April 2018 Quality College Course Descriptions





1 — GLP 101: Basic Training (2 Days)

Sunday, 8 April 2018, 8:00 a.m. - Monday, 9 April 2018, 5:00 p.m.

RQAP re-registration units: 4 GLP, non-GCP

*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units

Prices

  • Before 9 March 2018: Student Member Rate $375, Member Rate $745, Non-member Rate $895
  • After 9 March 2018: Student Member Rate $405, Member Rate $805, Non-member Rate $955

Speakers
Gregory Furrow
Beth Moulaison
Barbara Munch
Thomas Purdue
Sara Rybak
Gina Tucker
Lori Wright

Description

This course is a comprehensive introduction to FDA Good Laboratory Practice regulations or refresher training for all personnel involved in a nonclinical laboratory study. The course also provides a review of GLP history, examination of the FDA Preambles, offers topical comparisons between FDA and EPA requirements and OECD Principles, and is intended to equip the participant with a working knowledge of GLP impacts on study conduct. Opportunities for group interaction and breakout periods help widen the educational exchange while enhancing the learning process. 

Objectives
At the end of the course, the participants shall be able to: 
  • Understand 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 FDA GLPs and identify topical differences between FDA and EPA requirements and OECD Principles of GLP
  • 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
This course is a comprehensive introduction to FDA Good Laboratory Practice regulations or refresher training for all personnel involved in a nonclinical laboratory study.


Agenda
  • Basic GLP Training Overview
  • Landmark Cases in the Development of GLP
  • Organization of the GLP Regulations
  • Scope and Definitions
  • Contracting Under GLPs and Inspections of Testing Facilities
  • Organization and Personnel
  • Facilities
  • Equipment
  • Testing Facilities Operation
  • Test and Control Articles
  • The Protocol
  • Conduct of Nonclinical Laboratory Studies
  • Reporting of a Nonclinical Laboratory Study
  • Storage, Retrieval, and Retention
  • Electronic Record Keeping in Nonclinical Laboratory Studies
  • Shall vs. Should
  • FDA/EPA Regulations vs. OECD Principles of GLP


2 — GCP 101: Understanding the Basics (2 Days)

Sunday, 8 April 2018, 8:00 a.m. - Monday, 9 April 2018, 5:00 p.m.

RQAP re-registration units: 4 GCP, non-GLP

*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Prices

  • Before 9 March 2018: Student Member Rate $375, Member Rate $745, Non-member Rate $895
  • After 9 March 2018: Student Member Rate $405, Member Rate $805, Non-member Rate $955

Speakers
Tony Brewer
Jacqueline Bushong
Jamie Colgin
Jenny O'Brien
Cheryl McCarthy

Description
This is a basic course providing an overview of the fundamentals of Good Clinical Practice. Exercises will be conducted including review of electronic documents. Topics include: Principles of GCP, Key Regulations and Guidelines, Audit Standards, and applying them to several types of GCP audits. A mock audit exercise will be conducted to give some hands-on experience.

Objectives
At the end of the course, the participants shall be able to: 
  • Define Good Clinical Practices.
  • Identify the contents of GCPs.
  • Find key regulations within 21 CFR and ICH GCP E6(R2).
  • Describe 3-4 Activities to be performed during an audit.


Target Audience
This course is for clinical auditors with less than 1 year experience, or GMP/GLP auditors with no GCP experience.


Agenda
  • Principles of GCP
  • Key Regulations and Guidelines
  • Electronic Records and eSignatures
  • Protection of Human Subjects
  • Institutional Review Boards / Ethics Committees
  • Financial Disclosure
  • Clinical Trial Essential Documents
  • Drug Accountability
  • Safety Reporting
  • Investigator Site Audits
  • Service Provider Audits
  • Internal Audits
  • Regulatory Inspections

 


3 — CAPA 101: Problem Definition - Beyond Human Error (1 Day)

Sunday, 8 April 2018, 8:00 a.m. - 5:00 p.m.

RQAP re-registration units: 2 GCP, GLP

*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.


Prices

  • Before 9 March 2018: Student Member Rate $255, Member Rate $510, Non-member Rate $660
  • After 9 March 2018: Student Member Rate $285, Member Rate $570, Non-member Rate $720

Speakers
Eric Humes
Donna McElcar
Judy Zahora

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 and analyzing the causal factors. 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 allowed the issue not to be detected?).

Objectives
At the end of the course, the participants shall be able to: 
  • Understand the difference between reactive and proactive
  • Understand the advantage of a systematic methodology
  • Know what is CAPA?
  • Define a problem (case studies to be provided for hands-on)
  • Understanding high level process mapping
  • Apply root cause analysis, including process tools (fishbone/is-is not/5 Whys)
  • Develop corrective action that addresses the Root Cause


Target Audience
Basic 


4 — CSV 101: Basic Concepts in Computer Validation (2 Days)

Sunday, 8 April 2018, 8:00 a.m. - Monday, 9 April 2018, 5:00 p.m.

RQAP re-registration units: 4 GCP, GLP

*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Prices

  • Before 9 March 2018: Student Member Rate $375, Member Rate $745, Non-member Rate $895
  • After 9 March 2018: Student Member Rate $405, Member Rate $805, Non-member Rate $955

Speakers
Helene Andersson
Joe Franchetti
Frank Moschetto
Joe Whittemore

Description
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.

Objectives
At the end of the course, the participants shall be able to: 
  • Provide a thorough understanding of computer system validation by providing a framework on how to execute the System Life Cycle.
  • Address how 21 CFR Part 11 (electronic record/electronic signature requirements) fits into the validation process.
  • Be familiar with expected content for computer validation deliverables through workshop exercises and examination of example documents, as well as how to 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
  • Understanding the Regulations and Guidelines.
  • Identifying the Components of the System Life Cycle.
  • In-depth look at the Validation Deliverable.
  • Planning, Conducting and Documenting the Computer Validation Audit.


5 — GMP 101: Basic Training: History and Intro of US FDA GMPs (1 Day)

Sunday, 8 April 2018, 8:00 a.m. - 5:00 p.m.

RQAP re-registration units: 2 non-GCP, non-GLP

*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Prices

  • Before 9 March 2018: Student Member Rate $255, Member Rate $510, Non-member Rate $660
  • After 9 March 2018: Student Member Rate $285, Member Rate $570, Non-member Rate $720

Speakers
Megan Callan
Christine Garvey

Description
This course provides a history of the GMP regulations, what is the purpose, why were they created, how did they develop over time and an overview of the sections of the regulations.

Objectives
At the end of the course, the participants shall be able to: 
  • Understand the purpose of the GMP regulations.
  • How the regulations developed over time.
  • Provide an overview of the regulations.


Target Audience
Quality Assurance professionals and management looking for an overview of the GMP regulations.


Agenda
  • History and Introduction of the US FDA GMPs
  • Overview of 21CFR Parts 210 and 211
  • Out of Specifications
  • SOPs
  • QA versus QC
  • Review of Warning Letters


6 — GCP 301: Audits in Biostatistics (1 Day)

Sunday, 8 April 2018, 8:00 a.m. - 5:00 p.m.

RQAP re-registration units: 2 GCP, non-GLP

*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Prices

  • Before 9 March 2018: Student Member Rate $255, Member Rate $510, Non-member Rate $660
  • After 9 March 2018: Student Member Rate $285, Member Rate $570, Non-member Rate $720

Speakers
Rita Hattemer-Apostel
Allan Rosen

Description
GCP Audits in biostatistics are a relatively rare occurrence, especially when compared to the vast number of investigator site audits in a clinical trial. Reasons for this include that biostatistics processes are done only once for a clinical trial regardless of the number of trial sites included and subjects enrolled. Also because of the strong focus on investigator site audits, many GCP auditors have little opportunity and therefore lack the knowledge to perform audits in biostatistics. The course offers a unique training opportunity for GCP auditors to be better equipped to assess data integrity and enhance inspection readiness in biostatistics.

Objectives
At the end of the course, the participants shall be able to: 
  • Understand core procedures in biostatistics related to the conduct of clinical trials
  • Know the GCP regulatory requirements and expected documentation for biostatistics
  • Perform audits and identify deficiencies and weaknesses in biostatistics procedures followed in GCP trials


Target Audience
GCP auditors with an interest in broadening their audit portfolio and wish to assess processes in biostatistics. Experience in the conduct of GCP audits is expected for this course. Biostatisticians who are interested to learn what GCP auditors are looking for in such audits and would like to be better prepared for audits and inspections.


Agenda
  • 08:00 - 09:00 Introduction, GCP Requirements pertinent to Biostatistics
  • 09:00 - 10:00 Overview on GCP Audits (preparation, conduct, follow-up)
  • 10:15 - 12:00 Auditing Biostatistics Processes (Part I): Protocol and Amendments, Sample Size Estimation, Randomization, Data Monitoring Committee
  • 13:00 - 15:00 Auditing Biostatistics Processes (Part II): Statistical Analysis Plan, Statistical Analysis Programming, Interim Analysis, (Blind) Data Review Meeting
  • 15:15 - 16:30 Auditing Biostatistics Processes (Part III): Unblinding & Final Analysis, Statistical Report & Final Report, Validation of Computerized Systems
  • 16:30 - 17:00 Wrap-Up, Questions & Answers
The course includes four exercises:
1. Protocol Sections on Statistics
2. SAP and Tracking Sheet
3. Table and Figure
4. CSR and Protocol Deviations


7 — CAPA 201: Creation and Effectiveness - (Across GxPs) (1 Day)

Monday, 9 April 2018, 8:00 a.m. - 5:00 p.m.

RQAP re-registration units: 2 GCP, GLP

*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Prices

  • Before 9 March 2018: Student Member Rate $255, Member Rate $510, Non-member Rate $660
  • After 9 March 2018: Student Member Rate $285, Member Rate $570, Non-member Rate $720

Speakers
Bob Figarotta 
Eric Humes
Donna McElcar
Judy Zahora

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 CAPA Process; the purpose, effective CAPA creation and how to use the information for fundamental organization change.

Objectives At the end of the course, the participants shall be able to: 
  • Understand 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)
  • Ensure CAPA is valid and validated
  • Effectiveness checking of CAPA via internal audit review
  • Systematically implement global CAPA process


Target Audience
Intermediate to advanced. Must have completed the CAPA Problem Definition - Beyond Human Error class or have a solid understanding of Root Cause Analysis.


Agenda
  • 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
  • 3:00 pm - 3:15 pm
  • Break
  • 3:15 pm - 5:00 pm
  • CAPA Systems
  • Group Scenario - CAPA Systems and Communication
  • Q&A


8 — GLP 103: Basic GLP Archiving (1/2 Day)

Monday, 9 April 2018, 8:00 a.m. - 12:00 p.m.

RQAP re-registration units: 1 GLP, non-GCP

*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Prices

  • Before 9 March 2018: Student Member Rate $145, Member Rate $285, Non-member Rate $385
  • After 9 March 2018: Student Member Rate $175, Member Rate $345, Non-member Rate $445

Speakers

Arif Demirel
Kathryn Hackett-Fields
Colleen Hanson

Description
This course will provide participants with an overview of GLP archiving and lay the foundation for requirements, critical thinking and agency expectations. 

Objectives
At the end of the course, the participants shall be able to: 
  • Gain an understanding of GLP archiving
  • Identify archiving risk areas within an archive
  • Provide value to his/her site by educating internal and external clients on archiving requirements


Target Audience
The target audience for these sessions will be for new GLP archivists. Topics will range from the basics of archiving to electronic archiving and everything in between. While new members will get the most out of the class, seasoned archivists will find the courses beneficial as a refresher and to share ideas and experiences.


Agenda
  • 8:00-8:15 Welcome, Logistics and Introductions
  • 8:15-9:30 The Who, What, When, Where, Why, & How of GLP Archiving
  • 9:30-10:00 Electronic Archiving
  • 10:00-10:15 Beverage break
  • 10:15-10:30 Electronic Archiving
  • 10:30-11:45 Auditing the Archive
  • 11:45-12:00 Q&A and Wrap up


9 — GCP 202: Hot Topics & Industry Trends (1 Day)

Monday, 9 April 2018, 8:00 a.m. - 5:00 p.m.

RQAP re-registration units: 2 GCP, non-GLP

*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Prices

  • Before 9 March 2018: Student Member Rate $255, Member Rate $510, Non-member Rate $660
  • After 9 March 2018: Student Member Rate $285, Member Rate $570, Non-member Rate $720

Speakers
Chrissy Cochran, FDA
Glenda Guest
Lee Truax-Bellows

Description
This interactive workshop will provide experienced GCP QA professionals with additional skills and techniques to expand their knowledge and implementation of important new topics and trends in the QA field. This session has been designed to provide best practices and audience participation activities in employing effective interview techniques, preparing for upcoming Device GCP changes in the EU, understanding the MDSAP program and upcoming organizational and outreach efforts by US FDA. In addition to these topics, this session will also provide the regulatory perspective as it relates to the current status of GCPs as experienced in the global community.

Objectives
At the end of the course, the participants shall be able to: 
  • Apply more effective interview techniques during audits
  • Describe important upcoming changes to Device GCPs in the EU
  • Discuss pros and cons of the MDSAP program
  • Explain FDA re-organization and outreach efforts (FDA Rep to be invited)


Target Audience
GCP professionals with 2 or more years of experience.


Agenda
  • Overview of Quality Management in Clinical Trials E6(R2) focus
  • Understanding the MDSAP program
  • Preparing for EU Regulatory Device GCP changes
  • Employing Effective Interview Techniques When Auditing
  • FDA Re-organization and Outreach Activities Update


10 — GLP 301: Metrics and You: Perfect Together (1/2 Day)

Monday, 9 April 2018, 8:00 a.m. - 12:00 p.m.

RQAP re-registration units: 1 non-GCP, non-GLP

*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Prices

  • Before 9 March 2018: Student Member Rate $145, Member Rate $285, Non-member Rate $385
  • After 9 March 2018: Student Member Rate $175, Member Rate $345, Non-member Rate $445

Speakers
Nancy Catricks
Matthew Vaneman
Pamela Walker

Description
It's all about the data. In a study, that data is the raw data. For Testing Facility Management in a GLP facility, that data is metrics. During this course, we will explore perspectives of QA and Testing Facility Management on value-added metrics and how to use them to make sound decisions for improving operations.

Objectives
At the end of the course, the participants shall be able to: 
  • Identify 3 ways in which QA and Operations metrics can be utilized in a GLP laboratory.
  • List 3 types of metrics that could be implemented in a GLP laboratory.
  • Analyze the data from the metrics to make recommendations.

Target Audience
GLP QA management and Testing Facility Management responsibilities.


Agenda
  • Opening Overview of Metrics
  • QA Perspective and Data on Metrics
  • TFM and Operations Perspective on Metrics
  • Operational Data
  • Group exercise
  • Summary


11 — GLP 203: Intermediate GLP Archiving (1/2 Day)

Monday, 9 April 2018, 1:00 - 5:00 p.m.

RQAP re-registration units: 1 GLP, non-GCP

*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Prices

  • Before 9 March 2018: Student Member Rate $145, Member Rate $285, Non-member Rate $385
  • After 9 March 2018: Student Member Rate $175, Member Rate $345, Non-member Rate $445

Speakers
Arif Demirel
Kathryn Newland
Thomas Purdue

Description
This course will provide participants with a detailed overview of archiving and the regulatory landscape.

Objectives
At the end of the course, the participants shall be able to: 
  • Identify GLP risk areas in an archive
  • Develop a robust chain of custody process for the transfer of archived material
  • Provide value to his/her site by educating internal and external clients on archiving requirements


Target Audience
Archiving 201 is targeted for seasoned archivists with a more detailed look at the regulatory landscape and agency expectations.


Agenda
  • 1:00-1:10 Welcome, Logistics and Introductions
  • 1:10-1:15 Regulatory Landscape
  • 1:15-2:15 My archive is moving. What should I do and expect?
  • 2:15-3:00 Records Management - A corporate approach
  • 3:00-3:15 Beverage break
  • 3:15-4:30 Electronic Archiving
  • 4:30-5:00 Q&A and Wrap up

12 — SQA Leadership Development (1/2 Day)

Monday, 9 April 2018, 1:00 - 5:00 p.m.

RQAP re-registration units: 1 non-GCP, non-GLP

*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Prices

  • Before 9 March 2018: Member Rate $0 (This course is only for SQA Members)
  • After 9 March 2018: Member Rate $0 (This course is only for SQA Members)

Speakers
Alison Cockrell, SQA Executive Director
Kim Frazier, SQA Secretary
Stephen Rogenthien, SQA Vice-President
Lucy Wingett

Description
The SQA Board of Directors has created this course for SQA members. This course is designed to provide SQA members with tools and skills that will enable them to be better leaders in both SQA volunteer leadership positions as well as in other areas of their lives. It will provide a better understanding of SQA leadership responsibilities and an understanding of how SQA is governed. SQA members who are considering running for election or volunteering on Committees or within Specialty Sections will gain a better understanding of the requirements and responsibilities of the positions and the resources and assistance SQA offers to support those positions;. It will also provide an opportunity to meet and network with past, current and future SQA leaders and to develop and discuss leadership concepts through fun group exercises.

Objectives
At the end of the course, the participants shall be able to: 
  • Describe how to attract appropriate 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.
  • 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
  • Why, What, and How of developing leadership skills
  • Volunteers: what are they and why are they important
  • Finding appropriate volunteers
  • Why volunteer – WIIFM
  • Motivating and empowering volunteers
  • Leading long-distance committees
  • Goal planning
  • Determining and retaining members
  • How to inspire, delegate, motivate, assign tasks, follow-up on tasks
  • Fine art of delegation
  • Transition of volunteers/chair
  • Evaluating how you are doing
  • Thank you notes
  • EXERCISE: Communication
  • Aligning with the SQA Strategic Plan
  • Minutes and reports
  • Website use
  • SQA conference lines
  • EXERCISE: Game
  • Examples of Great Leaders/Q&A


13 — GLP 202: Regulatory Surveillance Inspections (1/2 Day)

Thursday, 12 April 2018, 1:30 - 5:30 p.m.

RQAP re-registration units: 1 GLP, non-GCP

*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Prices

  • Before 9 March 2018: Student Member Rate $145, Member Rate $285, Non-member Rate $385
  • After 9 March 2018: Student Member Rate $175, Member Rate $345, Non-member Rate $445

Speakers
Jennifer Bravo
Dominique Chan
Sherry Lee Dawson
James Farmer
Nina Sahay

Description
This course provides an overview of the FDA surveillance inspection process, in particular as it applies to GLP facilities. This course describes how to prepare for an agency inspection, how to host the inspection, and how to interact with regulators during and after the inspection. Additionally, this course will touch on the Canadian accreditation/ re-accreditation inspection process.

Objectives
At the end of the course, the participants shall be able to: 
  • Prepare for an agency inspection
  • Host an agency inspection
  • Understand FDA's current thinking and approach during inspections
  • Understand Canada's accreditation/re-accreditation process


Target Audience
This course is targeted to personnel (e.g. management, auditors, study personnel) who participate in regulatory agency inspection readiness activities and/or hosting regulatory inspections.


Agenda
  • Inspection readiness
  • Hosting regulatory inspections
  • Investigator's approach during inspections
  • FDA regulatory expectations and current thinking
  • Canada re-accreditation inspections


14 — General 103: The Biologics Super Highway (1/2 Day)

Thursday, 12 April 2018, 1:30 - 5:30 p.m.

RQAP re-registration units: 1 non-GCP, non-GLP

*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Prices

  • Before 9 March 2018: Student Member Rate $145, Member Rate $285, Non-member Rate $385
  • After 9 March 2018: Student Member Rate $175, Member Rate $345, Non-member Rate $445

Speakers
Deborah Parker
Lucy Podbielski

Description
Provide an overview of the science behind Ligand Binding Assays used in regulated bioanalysis. The course will cover both PK and ADA assays, and describe some of the areas where auditors should focus their review.

Objectives
At the end of the course, the participants shall be able to: 
  • Overview of the science of ligand binding assays (LBAs)
  • PK LBAs
  • ADA LBAs
  • Bioequivalence vs. Biosimilars
  • Biomarkers


Target Audience
Auditors new to bioanalysis and new to auditing large molecules.

Agenda
  • Overview of the science of ligand binding assays (LBAs)
  • PK LBAs
  • ADA LBAs
  • Bioequivalence vs. Biosimilars
  • Biomarkers


15 — General 101: QA Consulting (1/2 Day)

Thursday, 12 April 2018, 1:30 - 5:30 p.m.

RQAP re-registration units: 1 non-GCP, non-GLP

*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Prices

  • Before 9 March 2018: Student Member Rate $145, Member Rate $285, Non-member Rate $385
  • After 9 March 2018: Student Member Rate $175, Member Rate $345, Non-member Rate $445

Speakers
Angela Eichelberger
Lisa Fink
Robin Guy

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 necessities and niceties. This course is targeted for those QA professionals who want to learn more about consulting or have desire to pursue consulting as a career.

Objectives
At the end of the course, the participants shall be able to: 
  • Develop ideas for setting up and running a consulting practice.
  • Weigh the pros and cons of different types of legal and tax options.
  • Learn sponsor's (your client) expectations, needs and methods of interactions.
  • Understand what laboratories/CROs expect from you.


Target Audience
This course is targeted for those QA professionals who want to learn more about consulting or have desire to pursue consulting as a career.


Agenda
  • Introduction
  • Meeting expectations of your client (the Sponsor)
  • What the CROs expect from you as a consultant
  • Setting up and running your consulting company


16 — General 104: Three Cs of SOPs: Clear, Concise, and Compliant in a Regulatory Setting (1/2 Day)

Thursday, 12 April 2018, 1:30 - 5:30 p.m.

RQAP re-registration units: 1 GCP, GLP

*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Prices

  • Before 9 March 2018: Student Member Rate $145, Member Rate $285, Non-member Rate $385
  • After 9 March 2018: Student Member Rate $175, Member Rate $345, Non-member Rate $445

Speakers
Joe Franchetti
Barbara Munch
Michelle Thompson
Judy Zahora

Description
This course will cover the full life-cycle of controlled process documents - from creation through archival. Topics will also include responsibilities, training, and non-compliance. Attendees should be prepared to bring examples of questions relating to SOPs (controlled process documents) and SOP management.

Objectives
At the end of the course, the participants shall be able to: 
  • Understand the purpose and benefit of effective SOPs
  • Understand the critical role of SOPs in Quality Documentation systems
  • How to write a concise, unambiguous SOP for its intended purpose
  • Define clear responsibilities to promote action and closure within the document
  • Training requirements
  • Manage revisions, nonconformance and deviations from a current SOP
  • Difference between GCP/GLP/GMP


Target Audience
Anyone who is responsible for life cycle and compliance of these key components of the Quality Management System. This course is applicable to all; GMP, GCP, GLP, and GVP. This course is applicable for beginners as well as experienced personnel. 


Agenda
  • Understand the purpose and benefit of effective SOPs
  • Understand the critical role of SOPs in Quality Documentation systems
  • How to write a concise, unambiguous SOP for its intended purpose
  • Define clear responsibilities to promote action and closure within the document
  • Training requirements
  • Manage revisions, nonconformance and deviations from a current SOP
  • Difference between GCP/GLP/GMP
Class will include team exercises


17 — General 105: Bias Control: Protecting Us From Ourselves (1/2 Day)

Thursday, 12 April 2018, 1:30 p.m. - 5:30 p.m.

RQAP re-registration units: TBD

*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Prices

  • Before 9 March 2018: Student Member Rate $145, Member Rate $285, Non-member Rate $385
  • After 9 March 2018: Student Member Rate $175, Member Rate $345, Non-member Rate $445

Description
Not too long ago, Francis Bacon issued his philosophical work entitled, Novum Organum Scientiarum ('new instrument of science'), that continued our understanding about the scientific method by focusing on empirical investigation. He noted that as humans we are programmed to pay more attention to evidence that agrees with our preconceptions and to reject evidence that doesn't. If we want to learn more about the universe, we needed to take this inherent tendency toward natural bias into consideration in the design of scientific experimentation and focus on empirical investigation. It's been 400 years since Novum Organum and we still struggle with preventing non-random error from influencing research planning, conduct, analysis and reporting. This course will explore potential sources of error and bias in experimental research. We will review some of the real dangers of research bias through case studies and examples and go over some of the techniques used to control or limit bias in research. 

Objectives
At the end of the course, the participants shall be able to: 
  • Define experimental error and bias.
  • Explain the different types of bias that may affect experimental research and provide examples.
  • Describe the dangers in not controlling for research error and bias.
  • Describe techniques we can use to control or limit bias in research


Target Audience
QA professionals, Study Directors, PI, Study Monitors, GXP professionals


Agenda
  • Introduction
  • Definitions - What is Bias?
  • Random (non-systematic) versus Non-random (Bias) Error
  • Types of Research Bias
  • When can error occur in research?
  • Classification and examples in the GXP data life cycle - Selection, Information and Confounding bias
  • Error and Bias Impacts on data
  • Positive/negative error
  • Towards or away from the null
  • Controlling from Bias
  • Reducing error
  • Detailed examples of tools (e.g., blinding, randomization, interobserver reliability testing, sample size selection, etc)
  • Case Studies and Discussion


18 — GCP 201: Advanced Training (1 Day)

Friday, 13 April 2018, 8:00 a.m. - 5:00 p.m.

RQAP re-registration units: 2 GCP, non-GLP

*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Prices

  • Before 9 March 2018: Student Member Rate $255, Member Rate $510, Non-member Rate $660
  • After 9 March 2018: Student Member Rate $285, Member Rate $570, Non-member Rate $720

Speakers
Chrissy Cochran, FDA
Glenda Guest
Cheryl McCarthy
Vaska Tone
Lee Truax-Bellows
 
Description
This interactive session will provide experienced GCP QA professionals with advanced GCP QA tools to incorporate into how they perform audits, training and GCP support within their roles. This session 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 GCP into their roles.
  • Understand and implement a quality management system approach into their roles.


Target Audience
GCP Professionals with 2 or more years of experience.


Agenda
  • 8:00 - 8:30 Welcome, Housekeeping, Agenda Review and Introductions
  • 8:30-9:15 Components of a Quality Management System (QMS) 
  • 9:15-10:00 FDA’s Approach to a Quality Management System Approach in GCPs
  • 10:00 - 10:15 Break
  • 10:15 - 11:00 EU’s Approach to Quality Management System Approach in GCPs
  • 11:00 - 12:00 Practical Application of a Quality Management System (QMS) Approach Within the GCP Arena
  • 12:00 - 1:00 Lunch
  • 1:00 - 2:00 GCP Risk Management
  • 2:00 - 3:00 Root Cause Analysis and CAPA Under GCPs
  • 3:00 - 3:15 Break
  • 3:15-4:30 Additional Strategies for Planning, Conducting and Reporting Audits Under a QMS Approach
  • 4:30 - 5:00 Q&A


19 — CSV 203: Auditing in the GxP eData Space (1 Day)

Friday, 13 April 2018, 8:00 a.m. - 5:00 p.m.

RQAP re-registration units: 2 GCP, GLP

*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.


Prices

  • Before 9 March 2018: Student Member Rate $255, Member Rate $510, Non-member Rate $660
  • After 9 March 2018: Student Member Rate $285, Member Rate $570, Non-member Rate $720

Speakers
Conrad Kawaguchi
Timothy Kuhn

Description
Electronic Data (eData) is pervasive in the GxP world and auditors in that GxP eData space need to understand what is most important in these areas. This course will explore considerations in establishing an eData audit program, give auditors with little Technology/eData/Computer System Validation(CSV)/IT savvy the understanding needed to assess the eData/eSystems they encounter in the course of their existing GxP audits, and expand the understanding of eData auditors beyond the software vendor audit so as to know what is most important in GxP audits. The course will demonstrate "what to look for" for a variety of audits, both technology-focused and more conventional areas in which technology has "encroached."

Objectives
At the end of the course, the participants shall be able to: 
  • Establish and differentiate between the eData Audit Function and the Operational CSV Quality Roles.
  • List the considerations for the GxP eData Audit Program (Contributing to other GxP Audits, Independent Focused Data Integrity Audits, etc.)
  • Explore the various roles that the eData Auditor may serve as part of an audit (SME, Co-Auditor, Audit Lead)
  • Define and list the desired skill set for the eData Audit Team
  • Break down the various types of audits and risk areas for each: GLP Labs, Central Clinical Labs, Central Readers (eCG, Imaging, etc.), ePRO (Electronic Patient Reported
  • Outcomes - AKA Diaries), Acquisition Due Diligence, GMP Manufacturing Sites and Vendors, PV, eSystem Validation, Databases, IT Infrastructure, Cloud Providers, Software Providers, SaaS vendors, Pharma, Device, Combo Product, and others.


Target Audience
Seasoned Auditors with little eData/CSV experience or CSV professionals with little auditing experience.


Agenda
  • Establish and differentiate between the eData Audit Function and the Operational CSV Quality Roles.
  • List the considerations for the GxP eData Audit Program (Contributing to other GxP Audits, Independent Focused Data Integrity Audits, etc.)
  • Explore the various roles that the eData Auditor may serve as part of an audit (SME, Co-Auditor, Audit Lead)
  • Define and list the desired skill set for the eData Audit Team
  • Break down the various types of audits and risk areas for each: GLP Labs, Central Clinical Labs, Central Readers (eCG, Imaging, etc.), ePRO (Electronic Patient Reported Outcomes - AKA Diaries), Acquisition Due Diligence, GMP Manufacturing Sites and Vendors, PV, eSystem Validation, Databases, IT Infrastructure, Cloud Providers, Software Providers, SaaS vendors, Pharma, Device, Combo Product, and others.


20 — General 201: Systems Thinking in Quality Management (1 Day)*

*Please note that this is the course that was formerly called "New Perspectives in QA."

Friday, 13 April 2018, 8:00 a.m. - 5:00 p.m.

RQAP re-registration units: 2 GCP, GLP

*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.


Prices

  • Before 9 March 2018: Student Member Rate $255, Member Rate $510, Non-member Rate $660
  • After 9 March 2018: Student Member Rate $285, Member Rate $570, Non-member Rate $720

Speakers
Rita Hattemer-Apostel
Anthony Jones

Description
The course provides an opportunity for the QA auditor to learn about systems thinking, system dynamics and related areas and how that knowledge may enrich quality management and lead to a deeper understanding of the nature of QA. The intention of the course is to enhance the effectiveness of the QA auditor's own activities and interactions in QA with peers, colleagues and auditees and to develop and refine QA competence beyond the training of GXP regulatory requirements. The course will consist of short presentations/briefings and discussions, case studies, workshops and exercises where participants are invited to contribute. Participants must be able to communicate fluently in English.

Objectives
At the end of the course, the participants shall be able to: 
  • Understand key features of systems thinking and how they are related to quality assurance
  • Have a selection of new tools and techniques for achieving quality outcomes and building an effective QA function in partnership with their organization
  • Identify activities that will provide the key to future professional and personal development


Target Audience
GXP professionals with some experience in QA (ideally 3 or more years), who wish to learn about new topics related to QA, in particular systems thinking tools and techniques, enhance professional and personal growth and their contribution towards a quality organization. 


Agenda
  • The Status Quo
  • Where are we in QA? What's our role?
  • What are the expectations?
  • What keeps us busy?
  • Broadening the Perspective: Systems Thinking and more
  • Key Features of Systems Thinking
  • Systems Thinking and Quality Management – how to combine?
  • More Ideas from Cybernetics, Psychology and Management
  • Putting the new Tools and Ideas to Use
  • Clarifying the Personal Vision
  • Understanding Mental Models
  • Building a Shared Vision
  • Learning as a Team
  • Engaging to add Value
  • The Learning Organization
  • New Roles for QA: Designer, Facilitator, Teacher, Coach
  • Creating a Quality Culture


21 — General 106: Auditor's Primer: Chromatography & Mass Spectrometry (1 Day)

Friday, 13 April 2018, 8:00 a.m. - 5:00 p.m.

RQAP re-registration units: 2 GLP, GCP

*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Prices

  • Before 9 March 2018: Student Member Rate $255, Member Rate $510, Non-member Rate $660
  • After 9 March 2018: Student Member Rate $285, Member Rate $570, Non-member Rate $720

Speakers
Charlie Kirsch
Deborah Parker
Stephen Rogenthien
Kimberly Wheeler

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 cover incurred sample reanalysis and conducting failure investigations. This course is intended for beginner to intermediate level quality assurance professionals.


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


22 — GLP 102: History Behind the FDA GLPs (1/2 Day)

Friday, 13 April 2018, 8:00 a.m. - 12:00 p.m.

RQAP re-registration units: 1 GLP, non-GCP

*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Prices
  • Before 9 March 2018: Student Member Rate $145, Member Rate $285, Non-member Rate $345
  • After 9 March 2018: Student Member Rate $175, Member Rate $385, Non-member Rate $445

Speakers
Barbara Munch
Kathryn 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 Guidance Manual to recent 483s.

Objectives
At the end of the course, the participants shall be able to: 
  • Learn the history behind the FDA GLP regulations
  • Learn the correlation between the initial fraud, regulations, and CPGM
  • Learn how to apply the GLPs to situations at their local labs
  • Understand how to apply history learnings to write better findings


Target Audience
Anyone interested in understanding why the FDA GLP regulations were written and how they can be applied, spans from beginner to experienced professionals.


Agenda
  • History prior to 1970s
  • Searle Pharmaceutical, Searle Task Force
  • Industrial Bio-Test Lab
  • Monsanto
  • Hazleton Lab
  • Congressional hearing, Bressler Report
  • Regulatory action, IBT Trial
  • Practical exercises to write robust audit findings by applying history learnings to specific situations


23 — CSV 204: SEND-Implementation, Validation, and Outsourcing (1/2 Day)


Friday, 13 April 2018, 8:00 a.m. - 12:00 p.m.

RQAP re-registration units: 2 non-GCP, non-GLP

*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Prices
  • Before 9 March 2018: Student Member Rate $145, Member Rate $285, Non-member Rate $385
  • After 9 March 2018: Student Member Rate $175, Member Rate $345, Non-member Rate $445

Speakers
Vince D'Angelo
Joe Franchetti
Joanne Tyas

Description
The deadline for implementation of the FDA SEND initiative is a little over a year away and many are feeling the pressure to implement and validate a SEND solution. This course will cover the process flow for harmonization, implementation and validation of a SEND solution, including the regulatory requirements covering a SEND compliant submission and potential pitfalls that may be encountered along the way. Emphasis will be placed on points to consider when meeting the expectations of SEND and workshops will allow for open discussion of issues brought forward by attendees.

Objectives
At the end of the course, the participants shall be able to: 
  • Define the regulatory requirements covering a SEND submission.
  • List the elements of a compliant SEND submission.
  • Identify potential pitfalls in the implementation of a SEND solution.
  • Access the tools available for validation of a SEND solution.


Target Audience
Any individual who is embarking on the process of implementing and validating a SEND solution. This course is a basic-intermediate level.


Agenda
  • SEND: the basics
  • Business Implementation
  • Data Integrity Considerations
  • Outsourcing
  • Validation