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SQA Quality College

In Person: 12-13 and 16-17 March 2023 in National Harbor, MD, USA
Virtual: 20-21 and 28-30 March 2023

 

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 101 — Problem Definition – Beyond Human Error (one day, in person)

Sunday, 12 March 2023, 8:00 AM - 5:00 PM, EDT

 
Registration Rates
  • By 13 February 2023:  Member $640,  Non-member $800,  University/Government $485,*  Student/Outreach Members $330
  • After 13 February 2023:  Member $705,  Non-member $865,  University/Government $550,*  Student/Outreach Members $330
        Register Online
 
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

Christy Mazzarisi, Danielle Metzger, Renata Skros

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 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 did not allow the issue to be detected?). Shifting the mindset from reactive to proactive thinking.

Objectives
At the end of the course, the participants shall be able to: 
  • Explain the difference between reactive and proactive 
  • Explain the advantage of a systematic methodology (toolkit to be provided for hands-on activities)
  • Explain what RCA and CAPA are
  • Define a problem (case studies to be provided for hands-on activities)
  • Demonstrate high level use of industry best practice RCA tool (fishbone, is-is not/ 5 whys, etc.)
  • Apply root cause analysis principles
  • Generate CAPA plans against root causes 
Target Audience
Any Quality Professional who is involved in process improvement or Quality Events.
 
Agenda
  1. Define the problem – What, How Much, Where & When 
  2. Review Data to detect a “signal” 
  3. Apply Root Cause Analysis using toolkit
  4. Develop CAPA Plans

CSV 101 — Basic Concepts in Computer Validation (three partial days, virtual)

Tuesday-Thursday, 28-30 March 2023, 10:00 AM - 4:00 PM EDT

 
Registration Rates
  • By 13 February 2023:  Member $1030,  Non-member $1190,  University/Government $760,*  Student/Outreach Members $485
  • After 13 February 2023:  Member $1110,  Non-member $1270,  University/Government $840,*  Student/Outreach Members $485
        Register Online
 
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

Joe Franchetti, Joe Whitmore, Richie SIconolfi, Helen Andersson, Randy Basinger

Description
The purpose of this two-day introductory workshop training session is to provide the QA Professional with an overview of the validation process, regulatory expectations and auditing strategies based on industry standards and guidance. It also will provide the course attendees with an explanation of “how to get it done” by participating in breakout sessions and exercises that enhance their understanding of presented concepts. These concepts will be based on the industry-leading document from the Drug Information Association, Computerized Systems Used in Non-Clinical Safety Assessment: Current Concepts in Validation and Compliance. The guideline explores the current regulatory environment and new challenges in the development, validation, and use of computerized systems in non-clinical laboratories, while also describing the best practices to ensure their quality.

Objectives
At the end of the course, the participants shall be able to: 
  • Describe a framework on how to execute the System Life Cycle and its application to computer system validation.
  • Apply knowledge learned in workshop exercises and examination of example documents to real-life computer validation deliverables.
  • Develop the validation rationale for a variety of circumstances.
Target Audience
This course is designed for Validation, Quality, IT, and Business personnel responsible for implementing and using regulated computer systems in the pharmaceutical, biotech and medical device industries. The course is of special value to personnel seeking experience with computer validation and issues associated with regulated computer systems. The course is especially designed for attendees seeking a thorough introductory level of understanding, yet is also designed to be valuable to those with prior experience seeking to remain current with industry trends and approaches.
 
Agenda
  1. Understanding the Regulations and Guidelines
  2. Identifying the Components of the System Life Cycle
  3. In-depth look at the Validation Deliverable
  4. Planning, Conducting and Documenting the Computer Validation Audit

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

Sunday, 12 March 2023, 8:00 AM - Monday, 13 March 2023, 5:00 PM, EDT

 
Registration Rates
  • By 13 February 2023:  Member $1030,  Non-member $1190,  University/Government $760,*  Student/Outreach Members $485
  • After 13 February 2023:  Member $1110,  Non-member $1270,  University/Government $840,*  Student/Outreach Members $485
        Register Online
 
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

Jenny O'Brien, MaryEllen Lander, Dani Eaton, Dawn Niccum, Tony Brewer, Michele Weitz, Bernadette Bowen, Chrissy Cochran

Description
This course will provide presentations on topics as listed in the course objectives to ensure that course participants are given a thorough introduction to Good Clinical Practices for QA professionals.

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 (Regulation Book Provided)

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

Thursday, 16 March 2023, 1:30 - 5:30 PM, EDT

 
Registration Rates
  • By 13 February 2023:  Member $400,  Non-member $530,  University/Government $290,*  Student/Outreach Members $185
  • After 13 February 2023:  Member $465,  Non-member $595,  University/Government $355,*  Student/Outreach Members $185
        Register Online
 
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

Robin Guy, Kirk Smith, Steven Drzick, Nicolas Pelletier

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 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: 
  • List attributes of a good consultant.
  • Compare and contrast different types of legal and tax options.
  • Identify sponsor's (your client) expectations, needs and methods of interactions.
  • Identify the expectations of laboratories/CROs.
Target Audience
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

GEN 104 — The Three Cs of SOPs: Clear, Concise, and Compliant in a Regulatory Setting (half day, in person) - CANCELLED

Friday, 17 March 2023, 8:00 AM - 12:00 PM, EDT

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

Monday, 13 March 2023, 8:00 AM - 5:00 PM, EDT

 
Registration Rates
  • By 13 February 2023:  Member $640,  Non-member $800,  University/Government $485,*  Student/Outreach Members $330
  • After 13 February 2023:  Member $705,  Non-member $865,  University/Government $550,*  Student/Outreach Members $330
        Register Online
 
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
  1. Good Manufacturing Practices
  2. History of the US Food and Drug Administration
  3. Quality Management Systems
  4. Good Documentation Practices
  5. Electronic Records
  6. Change Control
  7. Deviation/Non-Conformance
  8. Plant Operations
  9. Laboratory Operations
  10. Regulatory Compliance
  11. Specialty Topics:
    • Medical Device
    • Phase Appropriate GMPs
  12. Phase Appropriate GMPs
 

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

Sunday, 12 March 2023, 8:00 AM - Monday, 13 March 2023, 5:00 PM, EDT

 
Registration Rates
  • By 13 February 2023:  Member $1030,  Non-member $1190,  University/Government $760,*  Student/Outreach Members $485
  • After 13 February 2023:  Member $1110,  Non-member $1270,  University/Government $840,*  Student/Outreach Members $485
        Register Online
 
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

Barbara Munch, Gina Tucker, Lori Wright, Greg Furrow, Beth Moulaison, Steve Drzick, Johanna Mazlo, Tim Valley, Theresa Donegan, Karen Waetjen, Eric Pittman

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 102 — Lies, Deceit, and Drift: The Creation of the FDA GLPs and Why They Are Still Relevant Today (half day, in person)

Monday, 13 March 2023, 8:00 AM - 12:00 PM, EDT

 
Registration Rates
  • By 13 February 2023:  Member $400,  Non-member $530,  University/Government $290,*  Student/Outreach Members $185
  • After 13 February 2023:  Member $465,  Non-member $595,  University/Government $355,*  Student/Outreach Members $185
        Register Online
 
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, Kathy Newland

Description
This training teaches the history behind the GLPs, why they were written as they were, and how to apply them in today's environment. The fraud uncovered by the FDA was astounding, and led to the creation of the GLPs. Have you heard of the magic pencil study or the swamp? Did you know that tissue masses were removed from live animals to "take a look to see what was inside"? This presents GLP training in a novel way, by linking fraud to regulations to SOPs to the FDA Compliance Program to recent 483s.

Objectives
At the end of the course, the participants shall be able to: 
  • Describe the history behind the FDA GLP regulations.
  • Compare the deceptions and fraud to the regulations and Compliance Program.
  • Use relevant course material to address situations at their firms or remote audits.
  • Apply history learnings to write more clear audit findings.
Target Audience
Anyone interested in understanding why the FDA GLP regulations were written and how they can be applied, This course spans from beginner to experienced professionals.
 
Agenda
  1. History prior to 1970s, including early pharma issues
  2. Searle Pharmaceutical, Searle Task Force
  3. Industrial Bio-Test Lab
  4. Monsanto
  5. Hazleton Lab
  6. Congressional hearing, Bressler Report
  7. Regulatory action, IBT Trial
  8. Practical exercises to write robust audit findings by applying history learnings to specific situations

GLP 103 — Basic GLP Archiving - What you need to know about GLP-compliant archives (half day, in person)

Monday, 13 March 2023, 1:00 - 5:00 PM, EDT

 
Registration Rates
  • By 13 February 2023:  Member $400,  Non-member $530,  University/Government $290,*  Student/Outreach Members $185
  • After 13 February 2023:  Member $465,  Non-member $595,  University/Government $355,*  Student/Outreach Members $185
        Register Online
 
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

Brooke Coblentz, Joyce Christian, Colleen Hanson

Description
This course answer the who, what, when, where, why & how of archiving (both physical and electronic) and associated processes.

Objectives
At the end of the course, the participants shall be able to: 
  • Summarize the basics of GLP Archiving
  • Describe electronic record archiving
Target Audience
GLP Auditors that audit archives, GLP Archivist and Archive staff
 
Agenda
  1. What Is a GLP - Compliant Archive?
  2. The Why:  Why Do We Archive Study Materials? Why Are GLP Complaint Archives A Best        Practice?
  3. The How:  How Does A GLP Archive Assure Completeness of the Record? How Does A GLP Archive Assure Record Integrity? How Do We Archive Study Materials? How Do the Archives Assure Retrievability?
  4. The What Else? What Happens to Records when they are delivered to the Archive? What Do We Archive? What do we use to protect Archives? What else do we Archive? What Hazards do we face when Archiving?  What permits might we need for Archival?  What are the exceptions to long-term Archival?
  5. The Who:  Staff Training: Who need it & What is required?  Who Supervises electronic Data and Procedures?  Who is responsible for getting materials to the ARchive? Who is respinsible for operations of the Archive?
  6. The When:  When are materials Archived?
  7. The Where:  Where do we archive materials?  Where have the investigators found lapses in GLP compliances? Some  regulatory findings related to Archiving
  8. Questions

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

Monday-Tuesday, 20-21 March 2023, 10:00 AM - 2:30 PM EDT

 
Registration Rates
  • By 13 February 2023:  Member $640,  Non-member $800,  University/Government $485,*  Student/Outreach Members $330
  • After 13 February 2023:  Member $705,  Non-member $865,  University/Government $550,*  Student/Outreach Members $330
        Register Online
 
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

Gina Tucker, Sara Rybak

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)

Friday, 17 March 2023, 8:00 AM - 5:00 PM, EDT

 
Registration Rates
  • By 13 February 2023:  Member $640,  Non-member $800,  University/Government $485,*  Student/Outreach Members $330
  • After 13 February 2023:  Member $705,  Non-member $865,  University/Government $550,*  Student/Outreach Members $330
        Register Online
 
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, Barb Munch, 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: 
  • Explain 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.
  • Identify 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
  1. The FDA GLP Compliance Program
  2. Compliance Program Content
  3. Managing an Inspection and Responses
  4. Remote Regulatory Assessments to On-site Inspections
  5. Other Useful FDA Documents
  6. Changes between Compliance Program versions
  7. Inspection Real Life Examples & Lessons Learned
  8. Discussion Topics

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

Thursday, 16 March 2023, 1:30 - 5:30 PM, EDT

 
Registration Rates
  • By 13 February 2023:  Member $400,  Non-member $530,  University/Government $290,*  Student/Outreach Members $185
  • After 13 February 2023:  Member $465,  Non-member $595,  University/Government $355,*  Student/Outreach Members $185
        Register Online
 
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, Steve Rogenthien, Greg Furrow, 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.

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
Anyone who is involved with FDA GLP work, including GLP QA, SD, TFM, etc.
 
Agenda
  1. Regulatory importance of preambles
  2. Review of each section of the GLP regulations and many important preambles
  3. Exercises to write regulation-based audit findings that reference the preambles

PV 101 — Pharmacovigilance Auditing - Basic Training (half day, in person)

Sunday, 12 March 2023, 1:00 - 5:00 PM, EDT

 
Registration Rates
  • By 13 February 2023:  Member $400,  Non-member $530,  University/Government $290,*  Student/Outreach Members $185
  • After 13 February 2023:  Member $465,  Non-member $595,  University /Government $355,*  Student/Outreach Members $185
        Register Online
 
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

Larry Thomas, Ann-Christin Becker, Cecilia Matos-Rosa, Cristina Uriarte, Crystal Dart, Vaska Tone

Description
This half-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 regulatory requirements for PV auditing.
  • Plan, conduct and report PV audits.
  • Identify compliance gaps in the PV system and suggest improvements based upon regulatory requirements.
  • Use the knowledge obtained by completing the training exercises to increase effectiveness as 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
  1. Introduction to PV auditing
  2. Regulatory basis for pharmacovigilance
  3. Audit planning
  4. Preparation and conduct of audits
  5. Auditing core PV topics
  6. Auditing PV interfaces and programs/studies
  7. Reporting
  8. Challenges of PV auditing, practical tips and best practices
 

Intermediate & Mixed Level Courses

CAPA 201 — CAPA Creation and Effectiveness - Beyond Training (one day, in person)

Monday, 13 March 2023, 8:00 AM - 5:00 PM, EDT

 
Registration Rates
  • By 13 February 2023:  Member $640,  Non-member $800,  University/Government $485,*  Student/Outreach Members $330
  • After 13 February 2023:  Member $705,  Non-member $865,  University/Government $550,*  Student/Outreach Members $330
        Register Online
 
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

Christy Mazzarisi, Danielle Metzger, Renata Skros

Description
An effective CAPA process begins with Root Cause Analysis and ends with CAPA Effectiveness. The process requires strategic direction, risk assessment, effective communication, accountability and responsibility agreed and clearly defined. This course will take a deep dive into the RCA, CAPA Process; the purpose, effective CAPA creation and how to use the information for fundamental organization change. Also, this course will teach how to use risk management principles during your RCA and CAPA planning to shift the organization to a proactive approach to CAPAs.

Objectives
At the end of the course, the participants shall be able to: 
  • Explain the value of an organization CAPA Process. 
  • 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).
    • Ensuring CAPA is valid and validated.
    • Checking effectiveness of CAPA via internal audit review and metrics review.
  • Describe how to shift to a proactive approach using Quality Risk Management.
Target Audience
Any Quality individuals who are a part of change management activities or Quality Events.
PREREQUISITE: Must have completed CAPA 101, Problem Definition – Beyond Human Error OR have a solid understanding of Root Cause Analysis principles and tools.
 
Agenda
  1. Review of Problem Definition and Root Cause Analysis
  2. Group Refresher Root Cause Analysis
  3. The Purpose of a CAPA
  4. How to Facilitate CAPA Effectiveness
  5. Group Practice (CAPA Steps 5-6)
  6. Lunch Break
  7. Group Practice and Report
  8. Fundamental Change through Trend Analysis and Process Improvement
  9. QRM Principles
  10. CAPA Systems
  11. Group Scenario – CAPA Systems and Communication
  12. Q&A

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

Monday, 13 March 2023, 1:00 - 5:00 PM, EDT

 
Registration Rates
  • By 13 February 2023:  Member $400,  Non-member $530,  University/Government $290,*  Student/Outreach Members $185
  • After 13 February 2023:  Member $465,  Non-member $595,  University/Government $355,*  Student/Outreach Members $185
        Register Online
 
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, Amanda Ulrey, additional speakers TBD

Description
Electronic records in the GxP woods are “lovely, dark, and deep”, but impossible to navigate if you don’t have an audit trail. To assure data integrity, individuals involved in a process, as well as Quality Assurance Auditors, need to review audit trails. How are audit trails reviewed when filtering is difficult? Do study monitors routinely review audit trails? Does the QAU address their audit trail practices in an SOP (as per OECD guidance)? When is audit trail review useful or necessary? This training has been developed following a 2019 SQA Annual Meeting 90 minute roundtable session. 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 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. The CVIC Data Integrity and Governance group has compiled several audit trail examples to use during discussions of scenarios. The examples, both real and fictitious, come from a variety of systems used in GLP, GMP, and GCP regulated industries. 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
  1. Introductions and Course Overview
  2. Data Integrity and Regulatory Requirements Overview
  3. Managing the Audit Trail Review Process and Paper Records Compared to their Electronic Audit Trail Equivalent
       (Topics covered include: who reviews them, where this process is defined, where the audit trails go, how to manage extensive audit trails)
  4. Group Work – Review of example audit trails and discussion
  5. Break Out One (Group Exercise 1)
  6. System Logs vs. Audit Trails
  7. Audit Trails in Action (Topics include: audit trail use as a monitoring tool for data integrity and audit trails for analyzed data)
  8. Break Out Two (Group Exercise 2)
  9. Warning Letter Review
  10. Break Out Three (Group Exercise 3)
  11. Q&A

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

Friday, 17 March 2023, 8:00 AM - 5:00 PM, EDT

 
Registration Rates
  • By 13 February 2023:  Member $640,  Non-member $800,  University/Government $485,*  Student/Outreach Members $330
  • After 13 February 2023:  Member $705,  Non-member $865,  University/Government $550,*  Student/Outreach Members $330
        Register Online
 
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, Lee Truax-Bellows, Pam Dellea-Giltner, Randall Basinger, Glenda Guest, Dawn Niccum

Description
This interactive workshop with expert industry and FDA speakers will focus on understanding digital vs electronic signatures and related risks; Decentralized Clinical Trial considerations; FDA Application "No-No's"; Key Risk/Performance/Quality Indicators and Quality Tolerance Limits; Proactive Quality Briefs to Support Regulatory Inspections and FDA's Planned Harmonization with The Common Rule. 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: 
  • Apply the concepts of key risk, performance and quality indicators and quality tolerance limits to their work.
  • Describe at least two things one should not do when submitting applications to FDA.
  • Explain the value of using Proactive Quality Briefs to support regulatory inspections.
  • Evaluate validity of digital and electronic signatures used in clinical research.
  • Give examples of considerations for decentralized clinical trial activities.
  • Explain proposed changes being made by FDA to harmonize with The Common Rule.
Target Audience
Experienced Quality Assurance professionals, 3+ years of experience, with an interest in learning more about new topics/trends in clinical research.
 
Agenda
  1. Quality Dossiers for GCP Inspections
  2. FDA Harmonization with the Common Rule, Part 1: IRBs and Cooperative Research
  3. FDA Harmonization with the Common Rule, Part 2: Protection of Human Subjects and IRBs
  4. FDA Updates and FDA Application No-No’s: A Dramedy
  5. Electronic Magic: Types of Electronic Signatures and Their Usage in Clinical Settings
  6. Decentralized Clinical Trail Activities: Things to Consider
  7. Key Risk Indicators (KRI), Key Performance Indicators (KPI), Key Quality Indicators (KQI) and Quality Tolerance Limits (QTL)
  8. Presenter Panel and Q&A

GCP 207 — You Suspect Fraud or Misconduct in Your Clinical Trial: Now What? (half day, in person)

Thursday, 16 March 2023, 1:30 - 5:30 PM, EDT

 
Registration Rates
  • By 13 February 2023:  Member $400,  Non-member $530,  University/Government $290,*  Student/Outreach Members $185
  • After 13 February 2023:  Member $465,  Non-member $595,  University/Government $355,*  Student/Outreach Members $185
        Register Online
 
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.

Presenters

Dawn Niccum, Bernadette Bowen, Greg Furrow, Scott Schillinger

Description
This interactive course will provide intermittent and experienced GCP QA professionals with techniques and tools to incorporate into how they detect and investigate suspected fraud and/or misconduct. This course will include an in-depth training regarding the regulatory requirements and best practices for managing cases of fraud and misconduct. The end of the course will include a Q&A session with the panel of GCP experts.

Objectives
At the end of the course, the participants shall be able to: 
  • Identify steps to take when fraud or misconduct is suspected.
  • Apply tools and techniques for the investigation.
  • Describe the methods to identify deliberate fraud.
Target Audience
Clinical QA professionals involved in the oversight or auditing of clinical trial sites.
 
Agenda
  1. Overview of fraud and misconduct, including regulatory requirements
  2. Detecting suspected cases
  3. Conducting a thorough investigation leading to confirmation of suspected fraud and misconduct
  4. Demonstration on conduct a for-cause audit
  5. Breakout session, exercises to learn how to detect fraud and misconduct
  6. Q&A Panel

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

Thursday, 16 March 2023, 1:30 - 5:30 PM, EDT

 
Registration Rates
  • By 13 February 2023:  Member $400,  Non-member $530,  University/Government $290,*  Student/Outreach Members $185
  • After 13 February 2023:  Member $465,  Non-member $595,  University/Government $355,*  Student/Outreach Members $185
        Register Online
 
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.

Presenters

Kerry Ellis, Michele Weitz

Description
GCP QA Professionals with an existing understanding of ICH Risk Management principles will have the opportunity to: 1) identify risks to clinical trial participants, data integrity, and regulatory compliance within their own work processes; 2) work in small groups to map a procedure that emphasizes the critical aspects of GCP risk management defined in ICH E6 (R2); and 3) outline a procedural document that addresses the risks identified in the workshop.

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
  1. Introduction and ice-breakers
  2. Brief review of GCP risk management concepts
  3. Identify risks in work processes
  4. In Small Groups: Select and map a process
  5. In Small Groups: Create procedural document outline
  6. All Attendees: Discussion of learnings and take-away messages
  7. Conclusion 

GEN 111 — Critical Thinking for Quality and Compliance (one day, in person) - CANCELLED

Sunday, 12 March 2023, 8:00 AM - 5:00 PM, EDT

 

 

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

Monday, 13 March 2023, 8:00 AM - 12:00 PM, EDT

 
Registration Rates
  • By 13 February 2023:  Member $400,  Non-member $530,  University/Government $290,*  Student/Outreach Members $185
  • After 13 February 2023:  Member $465,  Non-member $595,  University/Government $355,*  Student/Outreach Members $185
        Register Online
 
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

Steve Gompertz

Description
The term “guerilla tactics” likely conjures images of ragtag armed fighters skulking about the jungle to ambush a better outfitted target. A better definition in the context changing your organization’s culture around quality, is that of a member of a small independent group taking part in activities performed in an impromptu way, often without authorization. In business, we would more typically refer to such people as mavericks, leaders, change agents, or even loose-cannons, heretics, or disrupters. Regardless of which of those labels you consider positive or negative, the common theme is that they are people with strong convictions who persist and succeed in driving 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
  1. What are “Guerilla” Tactics?
  2. Common Quality Leadership Challenges
  3. Hide the Vegetables - Teaching new concepts without anyone realizing it
  4. Measurement Without Fear - Measuring Processes Rather Than People
  5. Less is More Documentation - Applying Lean Thinking to Documentation
  6. The 7 Habits of Highly Effective Quality Leaders - Stephen Covey’s Insights Applied to Quality Leadership

GEN 211 — Quality Management - Ethics Meets Compliance (one day, in person)

Monday, 13 March 2023, 8:00 AM - 5:00 PM, EDT

 
Registration Rates
  • By 13 February 2023:  Member $640,  Non-member $800,  University/Government $485,*  Student/Outreach Members $330
  • After 13 February 2023:  Member $705,  Non-member $865,  University/Government $550,*  Student/Outreach Members $330
        Register Online
 
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

Richie Siconolfi, Judy Zahora, Roxanne Law, Melanie Willis, Kamila Novak

Description
This new course was conceived at the end of the panel discussion “The Role of Ethics in Quality Culture” conducted at the SQA Annual Meeting 2022 and prompted by audience questions about continuing courses on ethics for QA professionals. Since such courses are scarce, the authors aim to fill this gap. The course includes key ethical concepts, their applicability in the regulated areas, case studies when ethics and compliance with regulations do not seem to align, situations when QA professionals may be exposed to ethically questionable situations and how to deal with them, ways to promote ethical awareness in organizations and the whole industry. The course is highly interactive with afternoon workshops focused on GCP, GLP, and GMP areas that will result in compiling a practical action list for the participants to apply.

Objectives
At the end of the course, the participants shall be able to raise awareness on how ethics complements compliance and ultimately improves quality by: 
  • Defining key ethical principles and behavior and their applicability in research and development.
  • Describing driving forces that may lead to ethically questionable decisions.
  • Clarifying where ethics and compliance intersect, align, collide, or divert.
  • Identifying and applying adequate response mechanisms to support ethical compliance.
  • Choosing, promoting, and supporting ethical decisions in difficult or grey-zone situations.
Target Audience
Quality Assurance professionals working in regulated areas (GMP, GCP, GVP, GLP).

Agenda
Morning Sessions:
  1. Introduction and setting the scene.
  2. Key ethical principles and behavior and clarification of definitions (e.g., moral, character, quality, integrity, ethical blindness vs. ethical awareness).
  3. Guidelines addressing ethics (e.g., Belmont Report, Declaration of Helsinki, etc.) – What is and what is not negotiable.
  4. Quality Management System: Driven by regulations only? How to infuse ethics into the QMS?
  5. Case studies: When ethics and compliance align or collide (examples, possible actions).
  6. Scenarios when QA professionals may be exposed to ethically questionable situations (examples, defense actions).
Afternoon Sessions: 
  1. Three roundtables (GCP, GLP, GMP; based on participants) with area-specific exercises/case studies, moderated discussions, brainstorming, etc. Each roundtable has a moderator / facilitator and a record-keeper.
  2. Joint discussion: How can I as a QA professional promote ethical awareness and behavior in my organization / the industry? Compile an action list (immediate, short-term, long-term actions).
  3. Recap, Take-aways, Adjourning.

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

Thursday 16 March 2023, 1:30 PM - Friday, 17 March, 5:00 PM, EDT

 
Registration Rates
  • By 13 February 2023:  Member $885,  Non-member $1045,  University/Government $665,*  Student/Outreach Members $440
  • After 13 February 2023:  Member $955,  Non-member $1120,  University/Government $715,*  Student/Outreach Members $440
        Register Online
 
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 understandingof GMP Quality Systems, ManufacturingOperations, Laboratory Operations, Facilities,Equipment, and Systems. Both near-term andlonger-term critical topics will be covered includingQuality 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:
  1. Rationale behind GMPs
  2. Quality Systems: Complaints, QRM CAPA, Out of Specifications/Trend, Supplier Qualification, AQR
  3. Manufacturing Technologies: Biologics Upstream, Downstream and Aseptic Fill, Aseptic Monitoring
  4. Laboratory Techniques: HPLC, GC, MSD, UPLC, micro, stability
  5. Quality Engineering: Facilities Utilities Equipment
  6. Qualification, Preventive Maintenance and Metrology
  7. Supplier Oversight
  8. Part 11: Electronic Records/Signatures
  9. Computer Software Validation-Data Integrity
  10. Laboratory Instrumentation and Manufacturing Equipment Qualification
  11. Compendia Method Verification
  12. Inspection Prep / Management
  13. Hosting U.S Inspections
  14. Responding to Observations
  15. Quality Management Maturity
  16. Quality Metrics

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

Sunday, 12 March 2023, 1:00 - 5:00 PM, EDT

 
Registration Rates
  • By 13 February 2023:  Member $400,  Non-member $530,  University/Government $290,*  Student/Outreach Members $185
  • After 13 February 2023:  Member $465,  Non-member $595,  University/Government $355,*  Student/Outreach Members $185
        Register Online
 
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: 
  • Explain strategies for accelerating their drug development while at the same time building quality into their products and processes.
  • Describe what strategic plans to put in place, sponsor vs. vendor responsibilities, and impact of priority reviews and fast track designations.
  • Describe the purpose of various types of stability studies and how to approach setting specifications.
  • List the benefits of front-end loading of CMC activities to increase efficiencies, reduce costs and protect patients.
Target Audience
Anyone interested in Chemistry, Manufacturing and Controls (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
 

Advanced Course

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

Sunday, 12 March 2023, 8:00 AM - 5:00 PM, EDT

 
Registration Rates
  • By 13 February 2023:  Member $640,  Non-member $800,  University/Government $485,*  Student/Outreach Members $330
  • After 13 February 2023:  Member $705,  Non-member $865,  University/Government $550,*  Student/Outreach Members $330
        Register Online
 
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

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

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 at least 3 years experience.
 
Agenda
  1. GCP Quality Management Systems (QMS) from a Regulator Perspective
  2. GCP QMS CAPAs from a Sponsor Perspective
  3. GCP QMS from an Auditing Perspective
  4. Auditing a Trial Master File

 

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