SQA Quality College

In Person: 6-7 and 10-11 April 2024 in Aurora, CO, USA
Virtual: 16-17 April 2024

 

Course Descriptions

Please note that individual courses will offer various RQAP Re-registration units, depending on the topic and length of the course. Unit categories include GCP/Non-GLP and GLP/Non-GCP.

 

Basic and Introductory Courses

CAPA 102 — Root Cause Analysis and the CAPA Lifecycle- Beyond Human Error and Training (two-day, in-person)

Saturday, 6 April 2024, 8:00 AM - Sunday, 7 April 2024, 5:00 PM, MDT

Note: In previous years, this course was offered as two separate courses, CAPA 101 and CAPA 201.


Registration Rates
  • By 12 January 2024:  Member $960,  Non-member $1105,  University/Government $705,*  Student/Outreach Members $450
  • 13 January - 4 March 2024: Member $1030,  Non-member $1190,  University/Government $760,*  Student/Outreach Members $485
  • After 5 March 2024:  Member $1110,  Non-member $1270,  University/Government $840,*  Student/Outreach Members $485
        Registration has closed.
 
RQAP re-registration units: 16.00 GCP or GLP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenters

Bob Figarotta, Christy Mazzarisi, Danielle Metzger

Description
Fundamental to an effective CAPA program is the practical application of Root Cause Analysis (RCA) and developing an understanding of the root cause(s), contributing cause(s), and possible cause(s) of the issue/problem. Defining the problem – setting boundaries – is integral to enabling an effective RCA. This course will provide tools, insight and best practice to support continuous process improvement and enable sustained results by emphasizing approaches to defining the problem, analyzing the causal factors, and applying RCA tools to develop robust CAPA plans. A common deficiency in many industry CAPA programs is a myopic RCA identifying human error and solely prescribing training as the preventive mitigation. By going beyond human error and training, the effective CAPA/EC program becomes a systematic assessment, focusing less on the individual and more on the process(es) in place (What about the process that allowed the issue to occur?) and the process quality control (What about the process that allowed the issue not to be detected?). Shifting the mindset from reactive to proactive thinking using risk management principles throughout the RCA lifecycle.

Objectives
At the end of the course, the participants shall be able to: 
  • Explain the difference between reactive and proactive (Quality Risk Management)
  • Describe the advantage of a systematic methodology (toolkit to be provided for hands-on activities)
  • Define a problem (case studies to be provided for hands-on activities)
  • Implement high level use of industry best practice RCA tool (fishbone, is-is not/ 5 whys, etc.)
  • Perform hands-on activities to generate CAPA plans against root causes
  • Move from Root Cause identified to corrective and preventative action by:
    • Developing a CAPA that addresses the Root Cause (case studies to be provided for hands-on)
    • Effectiveness checking of CAPA via internal audit review and metrics review (ECs)
Target Audience
Any Quality Professional who is involved with Quality Events or Process Improvements.
 
Agenda

Day 1:

  • Define the problem – What, How Much, Where & When
  • Review Data to detect a “signal”
  • Apply Root Cause Analysis using toolkit
  • Develop CAPA Plans

Day 2:

8:00 AM – 10:00 AM

  • Review of Problem Definition and Root Cause Analysis
  • Group Refresher Root Cause Analysis
10:00 AM – 10:15 AM - Break
10:15 AM – 12:00 PM
  • The Purpose of a CAPA
  • How to Facilitate CAPA Effectiveness
  • Group Practice (CAPA Steps 5-6)
12:00 PM – 1:00 PM - Lunch Break
1:00 PM –3:00 PM
  • Group Practice and Report
  • Fundamental Change through Trend Analysis and Process Improvement
  • QRM Principles
3:00 PM – 3:15 PM - Break
3:15 PM – 5:00 PM
  • CAPA Systems
  • Group Scenario – CAPA Systems and Communication
  • Q&A

 

GCP 101 — Understanding the Basics (two-day, in-person)

Saturday, 6 April 2024, 8:00 AM - Sunday, 7 April 2024, 5:00 PM, MDT

 
Registration Rates
  • By 12 January 2024:  Member $960,  Non-member $1105,  University/Government $705,*  Student/Outreach Members $450
  • 13 January - 4 March 2024: Member $1030,  Non-member $1190,  University/Government $760,*  Student/Outreach Members $485
  • After 5 March 2024:  Member $1110,  Non-member $1270,  University/Government $840,*  Student/Outreach Members $485
        Registration has closed.
 
RQAP re-registration units: 16.00 GCP or non-GLP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenters

Chris Both, Jonathan Campos (FDA), Aurea Flores, Glenda Guest, Nadine Jones, MaryEllen Lander, Camelia Lazalde, Cecilia Matos-Rosa, Cheryl McCarthy, Dawn Niccum, Audrey Vigil (FDA)

Description
This two day course will cover the evolution of GCP, applicable regulations and guidelines, GCP auditing of investigator sites and service providers, and applying what you have learned with interactive exercises.

Objectives
At the end of the course, the participants shall be able to: 
  • Define "Good Clinical Practice" and how it relates to the pharmaceutical development process
  • Describe the key aspects of GCP as it relates to data integrity, essential documents, informed consent, safety reporting, IP accountability, etc.
  • Explain GCP audits for investigator sites and vendor/service providers
Target Audience
CQA Professionals with 0-2 years of GCP QA experience
 
Agenda
  • Define Good Clinical Practice
  • Cite key events impacting the evolution of GCP
  • Familiarity with 21 CFR § 11, 50, 54, 56, 320 and ICH GCP

 

GEN 101 — QA Consulting (half-day, in-person)

Wednesday, 10 April 2024, 1:30 PM - 5:30 PM MDT

 
Registration Rates
  • By 12 January 2024:  Member $370,  Non-member $495,  University/Government $270,*  Student/Outreach Members $170
  • 13 January - 4 March 2024: Member $400,  Non-member $530,  University/Government $290,*  Student/Outreach Members $185
  • After 5 March 2024:  Member $465,  Non-member $595,  University/Government $355,*  Student/Outreach Members $185
        Registration has closed.
 
RQAP re-registration units: 4.00 non-GCP or non-GLP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenters

Jackie Bushong, Robin Guy, Kirk Smith, Deanna Talerico

Description
A consultant is an individual who possesses special knowledge or skills and provides that expertise to a client for a fee. This interactive course will give examples of the expectations of the sponsor (your client) and also CROs that host audits in certain situations. It will also cover ways of organizing the consulting business with regard to legal organization, tax information, physical office choices, marketing, payment structure, insurance and other important needs for a consultant. In addition, we will discuss hints and recommendations to bring more value to your clients and yourself as a consultant.

Objectives
At the end of the course, the participants shall be able to: 
  • Develop ideas for setting up and running a consulting practice
  • Evaluate the pros and cons of different types of legal and tax options
  • Identify sponsor's (your client) expectations, needs and methods of interactions
  • Determine what laboratories/CROs expect from you
Target Audience
This course is targeted to those QA Professionals who want to learn more about consulting or have a desire to pursue consulting as a career.
 
Agenda
  1. Introduction
  2. Meeting expectations of your client (the Sponsor)
  3. What the CROs expect from you as a consultant
  4. Setting up and running your consulting company
  5. How to be a valuable QA Consultant

 

GLP 101 — Basic Training in Good Laboratory Practice (two-day, in-person)

Saturday, 6 April 2024, 8:00 AM - Sunday, 7 April 2024, 5:00 PM MDT

 
Registration Rates
  • By 12 January 2024:  Member $960,  Non-member $1105,  University/Government $705,*  Student/Outreach Members $450
  • 13 January - 4 March 2024: Member $1030,  Non-member $1190,  University/Government $760,*  Student/Outreach Members $485
  • After 5 March 2024:  Member $1110,  Non-member $1270,  University/Government $840,*  Student/Outreach Members $485
        Registration has closed.
 
RQAP re-registration units: 16.00 GLP or non-GCP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenters

Theresa Donegan, Greg Furrow, Johanna Mazlo, Beth Moulaison, Barbara Munch, Eric Pittman (FDA), Thomas Purdue, Gina Tucker, Tim Valley, Karen Waetjen, Lori Wright

Description
This course is a comprehensive review of the FDA GLPs and offers topical comparisons between FDA and EPA requirements and provides a brief overview of the OECD Principles of GLP.

Objectives
At the end of the course, the participants shall be able to:
  • Describe the regulatory requirements for nonclinical laboratory facilities, equipment, personnel, methods, practices, records and controls to assure Management of compliance or report the lack thereof
  • Identify compliance gaps in the overall quality system of a facility and suggest improvements based upon regulatory requirements
  • Effectively communicate the requirements of EPA and FDA GLPs and identify topical differences between FDA and EPA requirements
  • Interpret and apply GLP requirements using a variety of resources
  • Use the knowledge obtained by completing the training exercises to increase effectiveness in current role

Target Audience
All levels of GLP experience 

Agenda
  1. Basic GLP training introduction
  2. Landmark cases in the development of GLPs
  3. Organization of GLPs
  4. Scope and Definitions
  5. Shall or Should (Legal Terminology)
  6. Contracts & Inspections
  7. Organization and Personnel
  8. Facilities
  9. Equipment
  10. SOPs, Reagents & Solutions, Animal Care
  11. Test and Control Articles
  12. Protocol
  13. Conduct of Nonclinical Laboratory Studies
  14. Reporting
  15. Storage, Retrieval, and Retention
  16. OECD Principles and Mutual Acceptance of Data
  17. Electronic Records

 

GLP 104 — Auditing Techniques (two half days, virtual)

Tuesday-Wednesday, 16-17 April 2024, 10:00 AM - 2:30 PM EDT

 
Registration Rates
  • By 12 January 2024:  Member $595,  Non-member $745,  University/Government $450,*  Student/Outreach Members $305
  • 13 January - 4 March 2024: Member $640,  Non-member $800,  University/Government $485,*  Student/Outreach Members $330
  • After 5 March 2024:  Member $705,  Non-member $865,  University/Government $550,*  Student/Outreach Members $330
        Registration has closed.
 
RQAP re-registration units: 8.00 GLP or non-GCP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenters

Sara Rybak, Gina Tucker

Description
This course is a comprehensive introduction to auditing GLP study data, final reports and facility records, utilizing data and examples from mock in-vitro and in-vivo studies. The course will incorporate how to effectively communicate and resolve audit observations. Opportunities for group interaction, interactive exercises, and discussion will enhance the learning process.

Objectives
At the end of the course, the participants shall be able to: 
  • Explain the regulatory requirements for FDA GLP QA, including high-level EPA/OCED GLP differences.
  • Describe regulatory inspection process for nonclinical laboratory facilities, including a review of the Bioresearch Monitoring Program (BIMO) Compliance Program Guidance Manual (CPGM).
  • Effectively communicate FDA GLP requirements to management and study personnel.
  • Audit protocols, laboratory records, electronic data and final reports for compliance with regulations.
  • Identify compliance gaps and effectively communicate gaps and recommendations for correction via an audit report.
  • Use knowledge and skills obtained through collaborative group exercises to enhance technical proficiency.
Target Audience
This course is a comprehensive introduction or refresher training for all personnel working within an FDA Good Laboratory Practice facility.
 
Agenda
  1. Course Overview
  2. Quality Assurance Responsibilities
  3. CPGM Overview
  4. Protocol Audits
  5. Process and Phase Inspections
  6. Facility Records
  7. Remote Auditing
  8. Electronic Records
  9. Study Data (including electronic data, and audit trails)
  10. Report Audit
  11. Writing and Resolving Audit Reports
  12. Quality Assurance Statements

 

GLP 105 — Introduction to FDA GLP Bioresearch Monitoring Compliance Program (one-day, in-person)

Thursday, 11 April 2024, 8:00 AM - 5:00 PM, MDT

 
Registration Rates
  • By 12 January 2024:  Member $595,  Non-member $745,  University/Government $450,*  Student/Outreach Members $305
  • 13 January - 4 March 2024: Member $640,  Non-member $800,  University/Government $485,*  Student/Outreach Members $330
  • After 5 March 2024:  Member $705,  Non-member $865,  University/Government $550,*  Student/Outreach Members $330
        Registration has closed.
 
RQAP re-registration units: 8.00 GLP or non-GCP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenters

Eric Pittman (FDA), Barb Munch, Gina Tucker, Lori Wright

Description
This class will review the FDA Compliance Program for Bioresearch Monitoring of the Good Laboratory Practice for Nonclinical Laboratory Studies (GLP) regulations (7348.808). FDA implemented this program of regular inspections and data audits to monitor laboratory compliance with the GLP regulations. The Compliance Program directs the FDA investigators on how to conduct their GLP inspections of firms. The class includes managing a FDA inspection, real-life examples of compliance issues, and explanations of relevant warning letter content.

Objectives
At the end of the course, the participants shall be able to: 
  • Understand how the FDA uses the Compliance Program to perform inspections
  • Apply the GLP Compliance Program information to build compliant processes
  • Manage an FDA Inspection and respond to a 483
  • Explain what records to provide the FDA Investigator/s during an inspection
  • Interpret selected warning letter findings based on understanding the Compliance Program and GLP regulations
Target Audience
FDA GLP QA Auditors and Managers, from beginners to experienced, as well as Study Directors, Principal Investigators, and Testing Facility Management
 
Agenda
  • The FDA GLP Compliance Program
  • Compliance Program Content
  • Managing an Inspection and Responses
  • Other Useful FDA Documents
  • Changes between Compliance Program versions
  • Inspection Real Life Examples & Lessons Learned and Discussion Topics

 

GLP 106 — FDA GLP Preamble Overview (half-day, in-person)

Sunday, 7 April 2024, 1:00 PM - 5:00 PM MDT

 
Registration Rates
  • By 12 January 2024:  Member $370,  Non-member $495,  University/Government $270,*  Student/Outreach Members $170
  • 13 January - 4 March 2024: Member $400,  Non-member $530,  University/Government $290,*  Student/Outreach Members $185
  • After 5 March 2024:  Member $465,  Non-member $595,  University/Government $355,*  Student/Outreach Members $185
        Registration has closed.
 
RQAP re-registration units: 4.00 GLP or non-GCP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenters

Barb Munch, Eric Pittman (FDA), Steve Rogenthien, Karen Waetjen

Description
This course is intended to review the proposed rule / final rule for 1976/1978, 1984/1987, and 1990/1991 FDA GLP Preambles, in sequence by regulation.  A new resource will be created that contains each preamble and regulation with the subsequent changes. Many of the important pieces of the preambles will be discussed, along with examples of how to apply the intent as provided by the FDA Commissioner. The class is encouraged to bring their own regulatory questions for discussion.

Objectives
At the end of the course, the participants shall be able to: 
  • Recognize the legal importance of preambles.
  • Identify many important preambles.
  • Interpret the preambles to apply when issues arise.
Target Audience
FDA GLP QA Professionals, intermediate to experienced Auditors and Managers, Study Directors, Principal Investigators, and Testing Facility Management
 
Agenda
  • Course Objectives
  • Review of Course Materials
  • Federal Rule Making
  • Preamble Use, Class Activity
  • Preamble Use, Presenter Examples
  • Attendee Open Question Time

 

GMP 101 — GMP Foundations (one-day, in-person)

Saturday, 6 April 2024, 8:00 AM - 5:00 PM, MDT

 
Registration Rates
  • By 12 January 2024:  Member $595,  Non-member $745,  University/Government $450,*  Student/Outreach Members $305
  • 13 January - 4 March 2024: Member $640,  Non-member $800,  University/Government $485,*  Student/Outreach Members $330
  • After 5 March 2024:  Member $705,  Non-member $865,  University/Government $550,*  Student/Outreach Members $330
        Registration has closed.
 
RQAP re-registration units: 8.00 non-GLP or non-GCP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenters

Edward Armstrong, Megan Callan, Steve Rogenthien

Description
This course provides an introductory overview of the History of the GMP Regulations, Quality Management Systems, Plant Operations, Laboratory Operations, Quality Engineering, Regulatory Compliance and select GMP Specialty Topics.

Objectives
At the end of the course, the participants shall be able to:
  • Describe the purpose of the GMP regulations and how the regulations developed over time
  • Apply the regulations in their work

Target Audience
Quality Assurance professionals with 0 – 2 years of GMP QA experience. 

Agenda
  • Good Manufacturing Practices
  • History of the US Food and Drug Administration
  • Quality Management Systems
  • Good Documentation Practices
  • Electronic Records
  • Change Control
  • Deviation/Non-Conformance
  • Plant Operations

 

PV 102 — Pharmacovigilance Auditing - Basic Training (one-day, in-person)

Saturday, 6 April 2024, 8:00 - 5:00 PM, MDT

 
Registration Rates
  • By 12 January 2024:  Member $595,  Non-member $745,  University/Government $450,*  Student/Outreach Members $305
  • 13 January - 4 March 2024: Member $640,  Non-member $800,  University/Government $485,*  Student/Outreach Members $330
  • After 5 March 2024:  Member $705,  Non-member $865,  University/Government $550,*  Student/Outreach Members $330
        Registration has closed.
 
RQAP re-registration units: 8.00 non-GCP or non-GLP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenters

Ann-Christin Becker, Michelleanne Bradley, Crystal Dart, Ebonie Gist, Loveleen Kukreja, Milind Nadgouda, Larry Thomas, and Karen Ward

Description
This one-day course is a practical session on pharmacovigilance auditing.  Methods of auditing and key compliance aspects of PV topics will be discussed. Numerous tips and best practices will be shared.  

Objectives
At the end of the course, the participants shall be able to: 
  • Explain the elements of a pharmacovigilance system, with a focus on PV auditing
  • Plan, conduct and report PV audits
  • Identify compliance gaps in the PV system and suggest improvements based upon regulatory requirements
  • Increase effectiveness as a PV auditor
Target Audience
Introductory to intermediate levels of experience with PV auditing.  This could include individuals transitioning to PV auditing from other quality areas, for example  GCP or GMP profession.
 
Agenda
  • Introduction to PV auditing
  • Regulatory basis for pharmacovigilance
  • The Holistic PV System and Auditing Core PV Topics
  • Audit Planning
  • Preparation and conduct of audits
  • Auditing PV interfaces and programs/studies
  • Reporting
  • Challenges of PV auditing, practical tips and best practices

 

NEW! RI 102 — 5 C's to respond to an FDA-483 (half-day, in-person)

Wednesday, 10 April 2024, 1:30 PM - 5:30 PM MDT

Note: This course falls under a new course designation, Regulatory Information (RI), which includes technical topics and concepts that are relevant across multiple QA disciplines.  

Registration Rates
  • By 12 January 2024:  Member $370,  Non-member $495,  University/Government $270,*  Student/Outreach Members $170
  • 13 January - 4 March 2024: Member $400,  Non-member $530,  University/Government $290,*  Student/Outreach Members $185
  • After 5 March 2024:  Member $465,  Non-member $595,  University/Government $355,*  Student/Outreach Members $185
        Registration has closed.
 
RQAP re-registration units: 4.0 GCP, GLP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenter(s)

Ed Armstrong, David Glasgow (FDA), Cheryl McCarthy, Barb Munch, Eric Pittman (FDA)


Description

In this new course, FDA personnel will review the FDA Investigations Operations Manual (IOM) regarding GCP, GLP, and GMP establishment inspections. The IOM directs FDA Investigators on how to conduct and report inspections including authority to enter, inspectional procedures, and reporting. SQA members from the industry will discuss differences and similarities between GCP, GLP, and GMP, when preparing for and hosting an FDA Inspection. Real-life examples of compliance issues will be presented, as well as a variety of scenarios with class participation with ways to respond, and ways not to respond, to an FDA Form 483.


Objectives

At the end of the course, the participants shall be able to:

  • Explain what to do when FDA identifies significant objectionable conditions and how to receive an FDA Form 483
  • Describe the FDA’s expectations regarding FDA Form 483 responses using the 5 C's
  • Identify and prevent incomplete or unclear FDA Form 483 responses that could lead to a Warning Letter
  • Identify relevant records that a firm should provide with their FDA Form 483 responses
  • Develop internal processes and training to generate FDA Form 483 responses that meet all 5 C’s

Target Audience

GCP GLP GMP QA auditors and managers, Study Directors, Testing Facility Management

 
Agenda

Topics discussed will include:

  • FDA Investigations Operations Manual (IOM)
  • IOM content relevant for inspections and FDA Form 483
  • Managing responses to an FDA Form 483
  • FDA Form 483 real life examples & lessons learned
  • Scenarios related to poor or proper FDA Form483 responses

 

RI 106 — Auditor’s Primer on the Science, Practice, and Auditing of Chromatography and Mass Spectrometry (one-day, in-person)

Thursday, 11 April 2024, 8:00 AM - 5:00 PM, MDT

Note: This course has been reassigned to a new course designation, Regulatory Information (RI), which includes technical topics and concepts that are relevant across multiple QA disciplines. It was listed as GEN 106 in previous years.  

Registration Rates
  • By 12 January 2024:  Member $595,  Non-member $745,  University/Government $450,*  Student/Outreach Members $305
  • 13 January - 4 March 2024: Member $640,  Non-member $800,  University/Government $485,*  Student/Outreach Members $330
  • After 5 March 2024:  Member $705,  Non-member $865,  University/Government $550,*  Student/Outreach Members $330
        Registration has closed.
 
RQAP re-registration units: 8.00 GCP or GLP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenters

Stephen Rogenthien, Natasha Savoie

Description

Chromatographic and mass spectrometric analyses provide critical data for many pharmacokinetic, dose analysis, safety, efficacy, and absorption, distribution, metabolism, and excretion (ADME) studies. Therefore, it is imperative that quality assurance professionals possess the knowledge and skills to properly audit this type of data. This course contains two distinct, but complimentary sessions.

The morning session covers the theory and practice of high-performance liquid chromatography (HPLC), ultra-performance liquid chromatography (UPLC), gas chromatography (GC), and mass spectrometry (MS). We will discuss auditing techniques, system suitability testing, incurred sample reanalysis (ISR), and failure investigation.

The afternoon session uses a problem-based learning (PBL) approach to enhance and hone the quality assurance professional’s skills for auditing chromatographic and mass spectrometric data. Participants will be placed into small teams and provided an example data and report packet to audit. We will then discuss the findings as a class. By combining background theory, practice, and applications with hands-on PBL, this course provides an all-around approach to auditing chromatographic and mass spectrometric analyses.


Objectives
At the end of the course, the participants shall be able to:
  • Identify different chromatographic techniques, their basic theory, and applications in a bioanalytical laboratory
  • Discuss mass spectrometry, its theory and applications
  • Define key chromatographic and mass spectrometry terms
  • Provide guidance on failure investigations
  • Use their newly gained understanding to better audit small molecule bioanalytical data

Target Audience
This course is for any quality assurance professional interested in understanding the science and auditing skills of bioanalytical chromatography and mass spectrometry. It will also over incurred sample reanalysis and conducting failure investigations. This course is intended for beginner to intermediate level quality assurance professionals

Agenda
  • Background (history) and types of chromatography
  • Theory and practice of HPLC/UPLC/GC
  • Theory and practice of mass spectrometry
  • Incurred Sample Reanalysis (ISR)
  • Failure investigations
  • Lunch break
  • Auditing chromatographic data
  • Auditing mass spectrometry data
  • Problem-Based Learning, Hands-On Exercise

 

 

Intermediate & Mixed Level Course

CSV 205 — Over the River and Through Woods: Following the Audit Trail (half-day, in-person)

Saturday, 6 April 2024, 1:00 - 5:00 PM, MDT

 
Registration Rates
  • By 12 January 2024:  Member $370,  Non-member $495,  University/Government $270,*  Student/Outreach Members $170
  • 13 January - 4 March 2024: Member $400,  Non-member $530,  University/Government $290,*  Student/Outreach Members $185
  • After 5 March 2024:  Member $465,  Non-member $595,  University/Government $355,*  Student/Outreach Members $185
        Registration has closed.
 
RQAP re-registration units: 4.00 GCP or GLP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenters

Chris Meister, Megan Gaydash, Joe Whittemore

Description
Electronic records in the GxP woods are “lovely, dark, and deep”, but impossible to navigate if you don’t have an audit trail. We will begin with an overview of the regulations covering audit trails and points made by regulators concerning audit trails and data integrity. This will be followed by more in-depth discussions and examples covering many questions with which auditors struggle, including the difference between system logs and audit trails and how both are useful in study based audits and data integrity audits. Individuals attending the training will leave with a greater understanding of points to consider concerning audit trails and more confidence in how to find compliance and data integrity problems when viewing audit trails.

Objectives
At the end of the course, the participants shall be able to: 
  • Describe requirements for electronic audit trails
  • Explain how both system logs and audit trails can be used to assess data integrity
  • Analyze a variety of compliant and non-compliant audit trails
  • Summarize gaps in compliance for example data based on audit trail review and recommend corrective actions
Target Audience
GLP, GCP, and GMP auditors responsible for reviewing and inspecting electronic instruments, equipment and system records and data. Anyone responsible for data integrity in electronic systems.
 
Agenda
  • Introductions and Course Overview
  • Data Integrity and Regulatory Requirements Overview
  • Managing the Audit Trail Review Process and Paper Records Compared to their Electronic Audit Trail Equivalent
  • Group work – Review of example audit trails and discussion
  • Break Out One (Group Exercise 1)
  • System Logs vs. Audit Trails
  • BREAK
  • Zoom Out and Make a Process (Topics covered include: who reviews them, where is this process defined, where do the audit trails go)
  • Audit Trails in Action (Topics include: audit trail use as a monitoring tool for data integrity and audit trails for analyzed data)
  • Break Out Two (Group Exercise 2) and/or Break
  • Warning Letter Review
  • Break Out Three (Group Exercise 3)
  • Discuss specific issues and questions
  • Open Discussion

 

DEV 204 — Risk Based Approach vs. Risk Management, and Determination of Acceptable Risk (half-day, in-person)

Thursday, 11 April 2024, 1:00 PM - 5:00 PM MDT

Note: This course has been re-designated. It was previously offered as GEN 214 in September 2023.

Registration Rates
  • By 12 January 2024:  Member $370,  Non-member $495,  University/Government $270,*  Student/Outreach Members $170
  • 13 January - 4 March 2024: Member $400,  Non-member $530,  University/Government $290,*  Student/Outreach Members $185
  • After 5 March 2024:  Member $465,  Non-member $595,  University/Government $355,*  Student/Outreach Members $185
        Registration has closed.
 
RQAP re-registration units: 4.00 non-GCP or non-GLP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenter(s)

Steve Gompertz

Description

Risk Based Approach and Risk Management are often incorrectly thought of and applied as synonyms when instead they are intended to be different but complimentary methods with a common goal of identifying and controlling risk. In addition, the so-called Risk Priority Number (RPN) has for many years been misconstrued as a measure of risk acceptability even though the name establishes its true purpose and limitations. This leads to further confusion over how to aggregate individual risks into overall product risk and then perform Benefit/Risk Analyses where quantification seems problematic. This presentation will be of interest to Quality Engineers and Quality System Managers, Directors, and VPs who want to learn how to make risk management much less painful and much more effective.

Objectives
At the end of the course, the participants shall be able to:
  • Explain differences between Risk-Based Approach and Risk Management
  • Describe why Risk Acceptability can't be determined by calculating a Risk Priority Number (RPN)
  • Explain "high" risks can still be acceptable
  • Aggregate individual risks into overall product/device risk
  • Clearly establish Benefit/Risk rationale
Target Audience
Medical Device Quality System Engineers, Managers, Directors, and VPs. Although this course is based on Medical Device standards, the content is easily applicable to other area where risk must be considered and managed.
 
Agenda
  • Understanding Risk-Based Approach
  • Formal Risk Management
  • Determination of Acceptable Risk

 

GCP 201 — Hot Topics & Industry Trends (one-day, in-person)

Sunday, 7 April 2024, 8:00 AM - 5:00 PM, MDT

 
Registration Rates
  • By 12 January 2024:  Member $595,  Non-member $745,  University/Government $450,*  Student/Outreach Members $305
  • 13 January - 4 March 2024: Member $640,  Non-member $800,  University/Government $485,*  Student/Outreach Members $330
  • After 5 March 2024:  Member $705,  Non-member $865,  University/Government $550,*  Student/Outreach Members $330
        Registration has closed.
 
RQAP re-registration units: 8.00 GCP or non-GLP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenters

Chrissy Cochran (FDA), Pam Dellea-Giltner, Paul Fenton, Glenda Guest, Cheryl McCarthy, Dawn Niccum, and Jeanine Pitts

Description
This interactive workshop will feature FDA and expert industry speakers sharing their experience on current issues and trends in clinical quality assurance. Please join us for an informative and fun day with plenty of time for questions and interaction with the speakers and your QA colleagues.

Objectives
At the end of the course, the participants shall be able to: 
  • Discuss the components expected as part of a Diversity Plan submitted for a clinical trial to the FDA
  • Describe the latest trends in decentralized clinical trials
  • Explain the updated rulemaking and guidances around informed consents
  • Forumulate a plan for audit trail review to ensure data integrity as part of oversight
  • Prepare for the updates within ICH E6 R3
  • Integrate risk-based techniques into auditing of TMFs
Target Audience
Experienced Quality Assurance professionals, 3+ years of experience, with an interest in learning more about new topics/trends in clinical research.
 
Agenda
  • FDA Mandate for Diversity Plans
  • Decentralized Clinical Trials - latest trends
  • Recent FDA notices of proposed rulemaking (2) and the recent informed consent guidance
  • Review of audit trails - how does this demonstrate oversight
  • Preparing for the ICH E6 R3
  • Advanced auditing techniques of the TMF

 

GCP 208 — Maximizing Risk Management in Your GCP SOPs (half-day, in-person)

Wednesday, 10 April 2024, 1:30 - 5:30 PM, MDT

 
Registration Rates
  • By 12 January 2024:  Member $370,  Non-member $495,  University/Government $270,*  Student/Outreach Members $170
  • 13 January - 4 March 2024: Member $400,  Non-member $530,  University/Government $290,*  Student/Outreach Members $185
  • After 5 March 2024:  Member $465,  Non-member $595,  University/Government $355,*  Student/Outreach Members $185
        Registration has closed.
 
RQAP re-registration units: 4.00 GCP or non-GLP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenter(s)

Kerry Ellis, Erin Wallace

Description

GCP QA Professionals with an existing understanding of ICH Risk Management principles will have the opportunity to work in small, guided groups to:

  1. Identify critical procedural steps and data
  2. Assign risk categories and compose risk questions
  3. Write steps that address the risks

Objectives
At the end of the course, the participants shall be able to: 
  • Evaluate critical work processes to identify potential risks to clinical trial participants, data integrity, and regulatory compliance
  • Outline a procedure that incorporates risk management language and concepts
  • Write a procedural document that addresses the defined risks
Target Audience
Anybody in a GCP Quality, Compliance, or Operations role with responsibility for writing or reviewing procedural documents within a GCP Quality System. Individuals in GxP roles could also benefit, though workshop examples will focus on GCP. Participants should have familiarity with Risk Management concepts defined in the ICH Guidelines.
 
Agenda
  • Introduction and ice-breakers
  • Brief review of GCP risk management concepts
  • Identify risks in work processes
  • In Small Groups: Select and map a process
  • In Small Groups: Create procedural document outline
  • All Attendees: Discussion of learnings and take-away messages
  • Conclusion 

 

NEW! GCP 209 — Challenges in Auditing Clinical Labs: Is CLIA Certification Enough? (half-day, in-person)

Saturday, 6 April 2024, 8:00 AM - 12:00 PM MDT

 
Registration Rates
  • By 12 January 2024:  Member $370,  Non-member $495,  University/Government $270,*  Student/Outreach Members $170
  • 13 January - 4 March 2024: Member $400,  Non-member $530,  University/Government $290,*  Student/Outreach Members $185
  • After 5 March 2024:  Member $465,  Non-member $595,  University/Government $355,*  Student/Outreach Members $185
        Registration has closed.
 
RQAP re-registration units: 4.0 non-GCP, non-GLP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenter(s)

Kim Frazier, Dawn Niccum, Jeanine Pitts


Description

This course will address challenges and provide tools for conducting clinical laboratory audits. Auditing of clinical laboratories presents a special challenge because the clinical trial regulations do not specifically address clinical laboratories. Presenters will discuss the application of principles of GLP, GCP, GCLP, CLIA certification, and other guidances to the conduct of these types of audits. This course will address auditing both larger laboratories and smaller specialty laboratories.


Objectives

At the end of the course, the participants shall be able to:

  • Describe the limitations of CLIA certification in ensuring regulatory compliance for clinical trials
  • Identify the critical areas of focus during the audits of clinical laboratories
  • Ensure clinical laboratories meet regulatory requirements for the processing of samples for the purposes of a clinical trial

Target Audience

QA professionals tasked with qualifying GCP laboratory facilities for use in clinical trials.

 
Agenda

This course will provide a mix of presentations, discussions and activities for the learners. Full agenda TBA.

 

GEN 102 — SQA Leadership Development (half-day, in-person)

Sunday 7 April 2024, 1:00 - 5:00 PM, MDT

 
Registration Rates
  • FREE for all SQA Members
  • By 12 January 2024:  Non-member $495,  University/Government $270*
  • 13 January - 4 March 2024: Non-member $530,  University/Government $290*
  • After 5 March 2024:  Non-member $595,  University/Government $355* 
        Registration has closed.
 
RQAP re-registration units: 1.00 non-GCP or non-GLP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenters

Jacqueline Bushong, Alison Cockrell, Kim Frazier, Tracy Henthorn, Michelle Holbrook, Cheryl McCarthy

Description

The SQA Board of Directors is pleased to again offer this in-person course to share how SQA can help our members interested in developing their leadership skills. As a volunteer organization, we recognize that there are many different ways to engage with our members. This course is intended to provide SQA members with tools and skills to provide insight on how to be an effective leader, both within SQA and other areas of their lives.

We will share information on SQA leadership responsibilities and how SQA as an organization is governed. SQA members who are considering running for an elected position or volunteering on a Committee or Specialty Section will learn about the requirements and responsibilities of these positions and the many SQA resources and assistance we offer in support of these positions.

We have leaders in many stages of their career as part of SQA. This course has some new content for 2024 so even if you have attended this course in the past, it continues to offer interactive and fun group activities on leadership concepts. Join us for this session to meet and network with past, current and future SQA leaders and join the conversation.

PLEASE NOTE: This is not a general leadership development course. While the course will discuss some general leadership tactics, it will primarily focus on topics relevant to leading an SQA Committee, Specialty Section, Chapter, or other affiliated group.


Objectives
At the end of the course, the participants shall be able to: 
  • Describe how to identify volunteers and how to get them actively involved
  • Discuss methods of motivating and rewarding volunteers
  • Describe how various leadership activities are linked to the SQA strategic plan
  • Identify areas where leadership skills can be used within SQA (examples include: Committees, Specialty Sections, Rapid Response Teams, Task Forces)
  • Implement effective leadership transition (when leaving a leadership position) so that progress can continue
  • Demonstrate practical and effective communication techniques
  • Identify who to ask for help with SQA leadership activities
  • Use the SQA website to effectively lead and manage committees, specialty sections, and/or other ad hoc groups and subcommittees within SQA
  • Use SQA Headquarters services to minimize workload and maximize results
Target Audience
This course is directed at SQA members who wish to become further involved with SQA in a leadership capacity, are considering becoming a future SQA leader or wish to further develop or gain knowledge of leadership skills.
 
Agenda

Identifying volunteers
  • Who are our volunteers?
  • Leveraging our volunteers’ strengths and passions
  • Volunteer Commitments
Aligning with the SQA Strategic Plan
  • Introducing the Roles/Responsibilities of the SQA Board of Directors
  • Goal Planning
Leadership Techniques
  • How to inspire, delegate, motivate, assign tasks, follow-up on tasks
  • Volunteer Appreciation
  • Transition of volunteers/chair
  • Effective Communication Methods
Resources
  • SQA Points of Contacts
  • Collaboration with SQA Headquarters
  • SQA Website
Interactive Activities
  • “What is: Jeopardy?”
  • Leadership Panel Q&A

 

GEN 111 — Critical Thinking by Design (half-day, in-person)

Saturday, 6 April 2024, 1:00 PM - 5:00 PM, MDT

 

Registration Rates
  • By 12 January 2024:  Member $370,  Non-member $495,  University/Government $270,*  Student/Outreach Members $170
  • 13 January - 4 March 2024: Member $400,  Non-member $530,  University/Government $290,*  Student/Outreach Members $185
  • After 5 March 2024:  Member $465,  Non-member $595,  University/Government $355,*  Student/Outreach Members $185
        Registration has closed.
 
RQAP re-registration units: 4.0 non-GCP, non-GLP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenter(s)

Anthony Jones

Description
In an era of growing complexity and information abundance, the role of critical thinking in the professional landscape, especially within Quality Assurance (QA), has never been more vital. The ability to think critically is now recognized as the linchpin of both success and failure in the workplace. This heightened importance is underscored by its increasing prevalence in industry guidance documents like GAMP and ICH E8. This course, designed for quality professionals and knowledge workers, offers an interactive learning experience. Through group discussions and thought provoking scenarios, participants will collaboratively refine their thinking skills, cultivate best practices, and forge a shared model for the application of critical thinking in the evolving world of QA and beyond.

Objectives
At the end of the course, the participants shall be able to: 
  • Apply a straightforward and practical framework for critical thinking, as acquired through interactive exercises, discussions, and idea-sharing with fellow course participants, leading to a fresh perspective on problem-solving
  • Distinguish between appropriate critical thinking approaches, enabling them to effectively address both simple and complex situations with greater confidence and precision
  • Utilize a diverse array of lenses and tools to enhance critical thinking, providing them with valuable resources for analyzing and approaching problems in their professional endeavors
Target Audience
All experience-levels of QA (and other) professionals who wish to expand their ability to apply critical thinking to quality and compliance problems.

Agenda
  • Session 1: The Art of Critical Thinking
    • Introduction to Critical Thinking
    • Time and Focus
    • Lenses and Tools
    • A Model for Critical Thinking
    • Problems, Puzzles, and Mysteries
  • Session 2: The Critical Thinking Process
    • Zooming-In and Zooming-Out
    • Understanding "What's in the Water?"
    • Deciding and Acting
  • Session 3: Scenarios to Challenge Thinking
    • Scenario-Based Learning
    • Analyzing Real-World Scenarios
    • Group Discussions
    • Interactive Problem-Solving
  • Session 4: Useful Lenses and Tools
    • Exploring Lenses
    • Cognitive Tools
    • Creating a Personal Toolkit
    • Course Conclusion and Reflection

 

GEN 209 — Wily Tactics for Quality Leadership (half-day, in-person)

Wednesday, 10 April 2024, 1:30 PM - 5:30 PM, MDT

 
Registration Rates
  • By 12 January 2024:  Member $370,  Non-member $495,  University/Government $270,*  Student/Outreach Members $170
  • 13 January - 4 March 2024: Member $400,  Non-member $530,  University/Government $290,*  Student/Outreach Members $185
  • After 5 March 2024:  Member $465,  Non-member $595,  University/Government $355,*  Student/Outreach Members $185
        Registration has closed.
 
RQAP re-registration units: 4.00 non-GCP or non-GLP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenter(s)

Steve Gompertz

Description
The term "wily tactics" might evoke thoughts of an individual that employs clever, cunning or possibly devious strategies to bring about a result by any means necessary. In the context of reshaping your organization's culture around quality, we often refer to such wily individuals as mavericks, leaders, change agents, or even as characters, heretics, or disrupters in the business world. Regardless of whether these labels are perceived positively or negatively, the shared characteristic is that these individuals possess strong convictions and effectively drive change.

Objectives
At the end of the course, the participants shall be able to: 
  • Implement new quality methods and concepts without conflict.
  • Obtain the data needed to drive analysis and decision making efficiently and without bias.
  • Create documentation that will ensure better comprehension and compliance.
  • Apply the “7 Habits of Highly Effective Quality Leaders”.
Target Audience
Anyone, whether in a formal leadership position or not, who wants to improve on making meaningful change happen and stick.
 
Agenda
  • What are “Wily” Tactics?
  • Common Quality Leadership Challenges
  • Hide the Vegetables - Teaching new concepts without anyone realizing it
  • Measurement Without Fear - Measuring Processes Rather Than People
  • Less is More Documentation - Applying Lean Thinking to Documentation
  • The 7 Habits of Highly Effective Quality Leaders - Stephen Covey’s Insights Applied to Quality Leadership

 

GEN 211 — Quality Management - Ethics Meets Compliance - CANCELLED

Sunday, 7 April 2024, 8:00 AM - 5:00 PM, MDT

GEN 213 — QMS Optimization: A Guide for Small Companies (one-day, in-person)

Thursday, 11 April 2024, 8:00 AM - 5:00 PM MDT

 
Registration Rates
  • By 12 January 2024:  Member $595,  Non-member $745,  University/Government $450,*  Student/Outreach Members $305
  • 13 January - 4 March 2024: Member $640,  Non-member $800,  University/Government $485,*  Student/Outreach Members $330
  • After 5 March 2024:  Member $705,  Non-member $865,  University/Government $550,*  Student/Outreach Members $330
        Registration has closed.
 
RQAP re-registration units: 4.00 non-GCP or non-GLP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenter(s)

Kamila Novak, Melanie Willis, Judy Zahora

Description

Ensuring quality is managed well and building a QMS fit for the purpose can be a challenging task for small companies and even more for start-ups with limited financial resources, manpower, and experience. In extremes, they may over-engineer it, license solutions fitting much larger companies with incomparable manpower, or neglect it. These extremes have a significant impact on their viability and future.

In this course, we will discuss and give examples of common pitfalls, as well as guide QA professionals and offer them tips to build a functional, scalable quality management system that can grow with their organization, as well as get the buy-in of organization personnel, Top Management included.

Objectives
At the end of the course, the participants shall be able to:
  • Identify common pitfalls, such as over-engineering the system that increases the risk of deviations from the designed processes and procedures or designing a system too weak increasing the risk of audit/inspection/due diligence findings
  • Design a fit-for-purpose QMS meeting quality and business objectives
  • Prepare justification of the proposed system
  • "Sell" the system to personnel to support compliance
Target Audience
QA professionals working in small or starting pharma, biotech, or medical device companies; GLP labs or CROs who are responsible to build, re-build, or improve a fit-for-the-purpose QMS in their organizations
 
Agenda
  • Not like this! Two bad examples – too much and too little
  • Fit-for-purpose QMS key considerations - GMP, GLP, GCP specifics
  • Is it fit for purpose? Business and compliance drivers
  • I start from scratch! Common constraints & what to do (manual QMS & eQMS)
  • I need to re-build it completely! How to manage change (manual QMS & eQMS)
  • Getting management buy-in
  • Getting personnel buy-in
  • Implementation steps
  • Does it work? Assessment of effectiveness
  • Continuing improvement
  • Afternoon Workshops

 

NEW! GEN 215 — Building a Quality Culture (half-day, in-person)

Saturday, 6 April 2024, 8:00 AM - 12:00 PM MDT

 
Registration Rates
  • By 12 January 2024:  Member $370,  Non-member $495,  University/Government $270,*  Student/Outreach Members $170
  • 13 January - 4 March 2024: Member $400,  Non-member $530,  University/Government $290,*  Student/Outreach Members $185
  • After 5 March 2024:  Member $465,  Non-member $595,  University/Government $355,*  Student/Outreach Members $185
        Registration has closed.
 
RQAP re-registration units: 4.0 non-GCP, non-GLP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenter(s)

Jeremiah Genest

Description

From the FDA's Quality Maturity Model to ICH E8, Quality Culture is a widely discussed concept. At the heart of culture is a set of behaviors and beliefs, that indicate what is important to the organization and drive all decision-making. Culture, and weaknesses within it, drive the root cause of many problems, and improving quality culture is an essential part of continuous improvement. This course will utilize best practices in nurturing and growing a quality culture within your organization by identifying behaviors, building key behavior indicators, and influencing individual and group behavior. At the end of the course, the participant will have a variety of tools that can be used in their own culture-building initiatives.

Objectives

At the end of the course, the participants shall be able to:

  • Identify the levels of culture within an organization
  • Develop values that drive desired quality behaviors
  • Implement key behavior indicators (KBI) to drive change within an organization
  • Identify relevant records that a firm should provide with their FDA Form 483 responses
  • Utilize key tools such as microfeedback, Gemba walks, and storytelling to build and maintain a Quality Culture
Target Audience

Quality leaders and managers engaged in building a quality culture in their organizations. This will be relevant to all quality areas across the GxPs.

Agenda
  • Identifying the elements and levers of a quality culture, including current regulatory agency thinking (45 min)
  • Building values that drive behavior (30 minutes)
  • Key behavior indicators (30 minutes)
  • Types of feedback, including applying microfeedback (45 minutes)
  • Gemba walks (30 minutes)
  • Building a Quality Culture Plan (30 minutes)
  • Call to Action (30 minutes)

 

NEW! GEN 216 — Performing More Effective Strengths, Weaknesses, Opportunities, and Threats (SWOT) Analyses (half-day, in-person)

Thursday, 11 April 2024, 8:00 AM - 12:00 PM MDT

 
Registration Rates
  • By 12 January 2024:  Member $370,  Non-member $495,  University/Government $270,*  Student/Outreach Members $170
  • 13 January - 4 March 2024: Member $400,  Non-member $530,  University/Government $290,*  Student/Outreach Members $185
  • After 5 March 2024:  Member $465,  Non-member $595,  University/Government $355,*  Student/Outreach Members $185
        Registration has closed.
 
RQAP re-registration units: 4.0 non-GCP, non-GLP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenter(s)

Steve Gompertz

Description

Analyzing strengths, weaknesses, opportunities, and threats through a SWOT Analysis is a common tool for strategic planning for businesses, business units, departments, or projects. The concept seems simple enough as the four elements are fairly easy to understand, but the results often seem to be subjective when the use of an “analysis” tool creates an expectation of more qualitative and definitive results.

The problem is often a result of using only one tool, brainstorming, for idea generation and not managing the use of that tool. While brainstorming is an ideal tool for starting this process, it isn’t the only tool that is needed to complete the process. Brainstorming tends to generate lots and lots of ideas, and without proper management can lead to generation of lots of redundant or irrelevant ideas.

The next step has to be leaning out the list to something more manageable and meaningful in terms of priorities. This is where subjectivity creeps in to muddy the waters based on participants’ biases, agendas, or perceived authority. A more democratic approach can address this and drive participants to consensus.

Lastly, knowing the priorities leads to the need to address them through action, where the same challenges pop up again in terms of generating too many options and not knowing how to select the right ones. This webinar presents a number of tips and tools to use to make this process much more effective in terms of producing more definitive and usable results.

Objectives

At the end of the course, the participants shall be able to:

  • More clearly explain the concepts of strengths, weaknesses, opportunities, and threats in relation to strategic planning
  • Condense even the most overwhelming brainstorming results into manageable common themes
  • Establish clear consensus on strategic priorities represented by those common themes
  • Identify effective action plans for implementing those strategic priorities
Target Audience

Quality and other leaders who participate in their organization's strategic planning.

Agenda
  • SWOT Concepts Overview
  • Idea Generation
  • Finding Common Themes
  • Prioritization
  • Action Planning

 

GMP 201 — Effective GMPs (1.5 days, in-person)

Wednesday 10 April 2024, 1:30 PM - Thursday, 11 April, 5:00 PM, MDT

 
Registration Rates
  • By 12 January 2024:  Member $825,  Non-member $970,  University/Government $620,*  Student/Outreach Members $410
  • 13 January - 4 March 2024: Member $885,  Non-member $1045,  University/Government $665,*  Student/Outreach Members $440
  • After 5 March 2024:  Member $955,  Non-member $1120,  University/Government $715,*  Student/Outreach Members $440
        Registration has closed.
 
RQAP re-registration units: 12.00 non-GCP or non-GLP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenters

Judy Carmody, Ed Armstrong

Description
The course provides a foundational understanding of GMP Quality Systems, Manufacturing Operations, Laboratory Operations, Facilities, Equipment, and Systems. Both near-term and longer-term critical topics will be covered including Quality Management Maturity, Quality Metrics, Data Integrity, Risk Management, Supplier Compliance, and Method Validation.

Objectives
At the end of the course, the participants shall be able to: 
  • Explain the foundations of GMP Quality and Compliance
  • Describe what to establish for in-house operations, what to look for when outsourcing, how to maintain compliance, and how to host an inspection
  • Summarize some risk-based approaches to GMPs
  • Identify where to access knowledge based on various GMP topics
Target Audience
  • Quality Assurance staff who may audit or review GMP operations
  • Industry Professionals who want GMP understanding
  • Appropriate for individuals with 2+ years in the industry

Agenda
Topics covered include:
  • Rationale behind GMPs
  • Quality Systems: Complaints, QRM CAPA, Out of Specifications/Trend, Supplier Qualification, AQR Manufacturing Technologies: Biologics Upstream, Downstream and Aseptic Fill, Aseptic Monitoring Laboratory Techniques: HPLC, GC, MSD, UPLC, micro, stability
  • Quality Engineering: Facilities Utilities Equipment
  • Qualification, Preventive Maintenance, and Metrology
  • Supplier Oversight
  • Part 11 - Electronic Records / Electronic Signatures
  • Computer Software Validation
  • Data Integrity
  • Laboratory Instrumentation and Manufacturing Equipment Qualification
  • Compendia Method Verification
  • Inspection Prep / Management
  • Hosting U.S Inspections
  • Responding to Observations
  • Quality Management Maturity
  • Quality Metrics

 

GMP 202 — Chemistry, Manufacturing, and Controls Strategies to Assure Quality While Accelerating Drug Development (half day, in person)

Sunday, 7 April 2024, 8:00 AM - 12:00 PM, MDT

 
Registration Rates
  • By 12 January 2024:  Member $370,  Non-member $495,  University/Government $270,*  Student/Outreach Members $170
  • 13 January - 4 March 2024: Member $400,  Non-member $530,  University/Government $290,*  Student/Outreach Members $185
  • After 5 March 2024:  Member $465,  Non-member $595,  University/Government $355,*  Student/Outreach Members $185
        Registration has closed.
 
RQAP re-registration units: 4.00 non-GCP or non-GLP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenters

Judy Carmody

Description
The development of therapeutics continues to accelerate with progress in chemistry and adoption of delivery and platform technologies. This course will discuss the necessary steps to execute to assure quality of your oligonucleotide Active Pharmaceutical Ingredients (APIs) and Drug Products (DPs), and compliance with agency expectations.

Objectives
At the end of the course, the participants shall be able to: 
  • Implement strategies for accelerating their drug development while at the same time building quality into their products and processes
  • Describe strategic plans to put in place, sponsor vs. vendor responsibilities, and the impact of priority reviews and fast-track designations.
  • Explain the purpose of various types of stability studies and how to approach setting specifications.

Most importantly, participants will gain perspective on the benefits of front-end loading of CMC activities to increase efficiencies, reduce costs, and protect patients.

Target Audience

Anyone interested in CMC, Impurity Control Strategies, manufacturing of therapeutics, and Quality Assurance during pre-clinical and clinical development of therapeutics or theranostics. This includes R&D Researchers, Manufacturing Personnel, Quality Assurance, Project Management, Business Development, and Scientific Management.

Appropriate for QA and other individuals with 2+ years of GMP experience in the industry or others in GLP or GCP who are interested in learning more about the GMP side of drug development.

Agenda
The course will include topics such as:
  • Sponsor and Vendor Responsibilities
  • Considerations for CMC, Regulatory, and Clinical Plans
  • Setting Specifications
  • Justifying Specifications
  • Stability-Method Validation

 

NEW!  GLP 205 — Moving GLP Compliance from Paper to Digital (half-day, in-person)

Saturday, 6 April 2024, 8:00 AM - 12:00 PM MDT

 
Registration Rates
  • By 12 January 2024:  Member $370,  Non-member $495,  University/Government $270,*  Student/Outreach Members $170
  • 13 January - 4 March 2024: Member $400,  Non-member $530,  University/Government $290,*  Student/Outreach Members $185
  • After 5 March 2024:  Member $465,  Non-member $595,  University/Government $355,*  Student/Outreach Members $185
        Registration has closed.
 
RQAP re-registration units: 4.0 GLP, non-GCP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenter(s)

Brendan Hyland, Jackie Torfin


Description

Is regulatory uncertainty keeping you from modernizing your GLP facility? Are you stuck with old software, paper archives, and "the printout is the raw data"? In this session we'll cover the different ways that you can 'go digital'; what the GLPs do and do not allow; and real strategies to help you modernize your GLP systems with confidence!


Objectives

At the end of the course, the participants shall be able to:

  • Identify candidates in their facility for modernizing workflows and systems
  • List the compliance requirements when implementing a technology for these candidates
  • Understand what the GLPs do and do not allow
  • Build a phased implementation approach to see immediate gains while preparing for the future

Target Audience

Management and other stakeholders in a GLP modernization effort, including:

  • QA Professionals
  • Quality Managers
  • Laboratory Managers
  • Validation Team Leaders
  • IT/KM Managers at GLP Facilities
 
Agenda

  • Module 1: Context & Motivation. Going Digital in a GLP Facility (45 minutes)
    • 1.1. Exercise: Where do you feel you are at with this topic?
    • 1.2. What does "Going digital" mean?
    • 1.3. GLP-relevant digital workflows
    • 1.4. Exploring the Benefits & Costs
    • 1.5. Group Breakout 1: Groups will choose a GLP-relevant workflow and work on those workflows throughout the course
  • Module 2: Modern GLP Compliance (1 hour)
    • 2.1. What’s different about GLP?
    • 2.2. Exercise. Are the Audit Trail requirements for GLP different than for other system?
    • 2.3. Can we Go Digital in a Compliant Manner?
    • 2.4. Where’s the FDA at Today?
    • 2.5. Why so few Part 11 Findings?
    • 2.6. *Exercise: Do we have to validate X??
    • 2.7. How about the EPA? OECDs?
    • 2.8. Digital GLP in the Wild
    • 2.9. *Group Breakout 2: What are the regulatory requirements around your workflow example? How would you satisfy them?
  • Module 3: Developing Requirements (1 hour)
    • 3.1. User vs. Regulatory Requirements
    • 3.2. GLP Requirements: Key Documents
    • 3.3. GLP Requirements: Inventories & Tracking
    • 3.4. GLP Requirements: Raw Data
    • 3.5. Exercise: Which is the raw data?
    • 3.6. GLP Requirements: Retained Records
    • 3.7. Archiving Electronic Data
    • 3.8. Exercise: Can a Backup be the Electronic Archives?
    • 3.9. Exercise: Can we subcontract electronic archives to IT?
    • 3.10. Backup vs Electronic Archives
    • 3.11. Group Breakout 3: Choose an example technology solution for your workflow. Start building a user requirements list. What are the options for data archiving & retention?
  • Module 4: Approach & Strategy (45 minutes)
    • 4.1. Approach
    • 4.2. Phased Implementation
    • 4.3. Building User Requirements
    • 4.4. Exercise: How Does the Archivist’s Role Change?
    • 4.5. Exercise: How does QA Change?
    • 4.6. Validation
    • 4.7. Case Studies
    • 4.8. Group Breakout 4: Build a phased implementation plan for modernizing your workflow
  • Q&A, Discussion & Conclusions (30 minutes)
    • Exercise: Where do you feel you are at with this topic now?

 

NEW! PV 202 — PV, QA, and AI: How to Not Do What We Have Always Done (half-day, in-person)

Sunday, 7 April 2024, 8:00 AM - 12:00 PM MDT

 
Registration Rates
  • By 12 January 2024:  Member $370,  Non-member $495,  University/Government $270,*  Student/Outreach Members $170
  • 13 January - 4 March 2024: Member $400,  Non-member $530,  University/Government $290,*  Student/Outreach Members $185
  • After 5 March 2024:  Member $465,  Non-member $595,  University/Government $355,*  Student/Outreach Members $185
        Registration has closed.
 
RQAP re-registration units: 4.0 non-GCP, non-GLP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenter(s)

Michelleanne Bradley


Description

This course will provide the structural framework to ensure that we are asking the relevant questions for implementation of AI solutions within QA and PV. Throughout this course, we will also consider the importance of including Subject Matter Experts in the development of AI solutions and validation.

Objectives

At the end of the course, the participants shall be able to:

  • Identify the potential benefits and challenges of using AI in pharmacovigilance (PV)
  • Describe some specific examples of how AI is currently being used in PV
  • Discuss ethical implications of using AI in PV
  • Identify potential future directions for AI in PV
  • Use AI to identify patterns and trends in PV
  • Develop predictive models for PV with AI

Target Audience

GVP, GCP, IT, Regulatory, and Quality Assurance professionals with interest in applications and approaches to implementation of Artificial Intelligence in PV functional areas.

Agenda

Topics discussed will include:

  • Introduction to AI in Pharmacovigilance (PV) and Quality Assurance (QA)
  • Ethics in Healthcare
  • AI applications in Pharmacovigilance
  • Ethical Considerations in AI Applications
  • Quality Assurance in Pharmacovigilance
  • AI for Quality Assurance
  • Ethical Guidelines and Regulations
  • Case Studies and Best Practices
  • Integrating Ethical AI and Quality Assurance
  • Ethical Challenges and Future Trends
  • Group Discussions
  • Assessment and Evaluation
  • Conclusion and Wrap-up

 

 

Advanced Courses

GCP 301 — Advanced Training in GCP (one-day, in-person)

Thursday, 11 April 2024, 8:00 AM - 5:00 PM, MDT

 
Registration Rates
  • By 12 January 2024:  Member $595,  Non-member $745,  University/Government $450,*  Student/Outreach Members $305
  • 13 January - 4 March 2024: Member $640,  Non-member $800,  University/Government $485,*  Student/Outreach Members $330
  • After 5 March 2024:  Member $705,  Non-member $865,  University/Government $550,*  Student/Outreach Members $330
        Registration has closed.
 
RQAP re-registration units: 8.00 GCP or non-GLP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenters

Chrissy Cochran (FDA), Pam Dellea-Giltner, Glenda Guest, Lee Truax-Bellows

Description
This interactive course will proved experienced GCP QA professional with advanced GCP QA tools to incorporate into how they perform audits, training and GCP support within their roles.  This course has been designed to provide best practices and audience participation activities that highlight the experience of the presenters and the attendees. 

Objectives
At the end of the course, the participants shall be able to: 
  • Incorporate presented professional development and advanced audit and training techniques into their roles
  • Incorporate current regulations and guidelines that impact CGP into their roles
  • Describe and implement a quality management system approach into their roles
Target Audience
GCP auditors with 3 or more years of experience
 
Agenda
  • GCP Quality Management Systems (QMS) from a Regulatory Perspective
  • GCP QMS CAPAs from a Sponsor Perspective
  • Best Practice or Regulations?
  • Update on ICH E6 (R3) Guidance
  • Auditing a Trial Master File

 

NEW! GMP 301 — Advanced GMP (one-day, in-person) - CANCELLED

Sunday, 7 April 2024, 8:00 AM - 5:00 PM MDT

 

NEW! GLP 302 — Quality Assurance for New Approach Methodologies (half-day, in-person)

Saturday, 6 April 2024, 1:00 PM - 5:00 PM MDT

 
Registration Rates
  • By 12 January 2024:  Member $370,  Non-member $495,  University/Government $270,*  Student/Outreach Members $170
  • 13 January - 4 March 2024: Member $400,  Non-member $530,  University/Government $290,*  Student/Outreach Members $185
  • After 5 March 2024:  Member $465,  Non-member $595,  University/Government $355,*  Student/Outreach Members $185
        Registration has closed.
 
RQAP re-registration units: 4.0 non-GCP, non-GLP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenter(s)

Mark Seaton (FDA), Amanda Ulrey


Description

The field of toxicology and pre-clinical testing is changing due to the emergence of new technologies such as organ/human-on-a-chip, novel in silico tools for safety assessment, and regulatory drivers for transitioning to human relevant models for regulatory use. Quality assurance professionals need to expand their skills to properly assess these methods both when they are used within the context of regulatory studies and prior to regulatory use when the focus of the work is on establishing the credibility and reliability of these New Approach Methodologies or NAMs. This Quality College course is designed to introduce quality professionals to the principles and practices described in OECD guidance document 286.


Objectives

At the end of the course, the participants shall be able to:

  • List several ways to improve the quality of methodologies and studies using cells, tissues, and microphysiological systems as the test systems
  • Describe considerations important in assuring the quality of regulated in vitro work
  • Explain Good In Vitro Method Practices (GIVIMP)
  • Describe how GIVIMP can be applied outside of regulated work to support the integrity of NAMs

Target Audience

Quality Assurance auditors who wish to gain an understanding of how to audit non-animal based test methods, or anyone interested in improving the quality and data integrity of New Approach Methodologies (NAMs). It is helpful if participants have a good understanding of GLP regulations.

 
Agenda

The course begins with an exploration of the foundational principles that underpin Good In Vitro Method Practices (GIVIMP) and GIVIMP's significance in maintaining high standards of quality for not just the performance of a study, but for the design and development of NAMs. Participants will gain insights into why GIVIMP was developed and where the application of GIVIMP principles are helpful in both academic and industry laboratories.

Participants will work through the chapters of GIVIMP and discuss topics such as roles and responsibilities; facility design; apparatus, material and reagents; test systems; test, reference and control items; standard operating procedures; performance of the method; reporting of results; and storage and retention of records and materials. Special attention will be given to those areas that differ from what is required for animal based studies and to those recommendations that differ from what is described in Good Laboratory Practice (GLP) regulations. A basic understanding of GLPs will be helpful but not necessary for this course. Through practical examples and case studies, participants will learn how recommendations within GIVIMP can be implemented within a laboratory to support reliable and reproducible science. The course aims to empower quality assurance professionals with the knowledge and tools necessary to navigate the complexities of in vitro methods, ensuring that the highest standards of quality and reliability are met in any lab.

 

 

* University staff and government employees — select the University option as registration type.