SQA April 2022 Quality College

3-4, and 7-8 April 2022, Online and in Palm Springs, CA, USA
Virtual-only Course 11 April 2022

 

Course Descriptions

 

1 — GLP 101: Basic Training (Two-day, In person only)

Sunday, 3 April 2022, 8:00 AM - Monday, 4 April 2022, 5:00 PM, PDT

Registration Rates

• By 7 March 2022:  Member $795,  Non-member $945,  University Members $585,*  Student/Outreach Members $375
• After 7 March 2022:  Member $855 , Non-member $1,005,  University Members $645,*  Student/Outreach Members $375

RQAP re-registration units: 16.00 GLP or non-GCP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenters

Theresa Donegan, RQAP-GLP; Greg Furrow;  Johanna Mazlo, RQAP-GLP; Beth Moulaison; Tom Purdue, RQAP-GLP; Tim Valley; Karen Waetjen, RQAP-GLP

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:

• 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
• 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. Shall or Should
5. Scope and Definitions
6. Contracting under GLPs
7. Organization and Personnel
8. Facilities
9. Equipment
10. Testing Facility Operation
11. Test and Control Articles
12. Protocol
13. Conduct of Nonclinical Laboratory Studies
14. Reporting
15. Storage, Retrieval, and Retention
16. Electronic Records
17. OECD Principles
    
     

 

2 — GCP 101: Understanding the Basics (Two-day, In person only)

Sunday, 3 April 2022, 8:00 AM - Monday, 4 April 2022, 5:00 PM, PDT

Registration Rates

• By 7 March 2022:  Member $795,  Non-member $945,  University Members $585,*  Student/Outreach Members $375
• After 7 March 2022:  Member $855 , Non-member $1,005,  University Members $645,*  Student/Outreach Members $375

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

Jackie Bushong, RQAP-GCP; Chrissy Cochran, PhD (FDA); Cheryl McCarthy, RQAP-GCP, CMDA

Description
This 2 day course will cover the evolution of GCP, applicable regulations & guidelines, GCP auditing of investigator sites & service providers, and applying what you have learned with interactive exercises.

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

• Define what constitutes Good Clinical Practices
• Cite key events impacting the evolution of GCP
• Familiarity with 21 CFR § 11, 50, 54, 56, 320 and ICH GCP (Regulation Book Provided)

Target Audience
Quality Professionals with no GCP experience up to 1 year experience. This is a very basic course.
 
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)

 

3 — CSV 101: Basic Concepts in Computer Validation (Two-day, In person and virtual)

Sunday, 3 April 2022, 8:00 AM - Monday, 4 April 2022, 5:00 PM, PDT

Registration Rates

• By 7 March 2022:  Member $795,  Non-member $945,  University Members $585,*  Student/Outreach Members $375
• After 7 March 2022:  Member $855 , Non-member $1,005,  University Members $645,*  Student/Outreach Members $375

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

Helene Anderson, Randy Basinger, Joe Franchetti, Richie Siconolfi, 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.
• 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
  
  

 

4 — GMP 101: GMP Foundations (One-day, In person and virtual)

Sunday, 3 April 2022, 8:00 AM - 5:00 PM, PDT

Registration Rates

• By 7 March 2022:  Member $495,  Non-member $615,  University Members $375,*  Student/Outreach Members $255
• After 7 March 2022:  Member $545,  Non-member $665,  University Members $425,*  Student/Outreach Members $255

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
Edward Armstrong, Megan Callan, Steve Rogenthien, RQAP-GLP
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 this course participants will be able to understand the purpose of the GMP regulations, how the regulations developed over time, provide a foundation of the regulations.

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

Agenda

• Course Agenda
• Good Manufacturing Practices
• History of the US Food and Drug Administration
• Quality Management Systems
• Good Documentation Practices
• Electronic Records
• Change Control
• Deviation/Non-Conformance
• Plant Operations
• Laboratory Operations
• Regulatory Compliance
• Specialty Topics:
  • Medical Device
  • Phase Appropriate GMPs

 

5 — CAPA 101: Problem Definition – Beyond Human Error (One-day, In person only)

Sunday, 3 April 2022, 8:00 AM - 5:00 PM, PDT

Registration Rates

• By 7 March 2022:  Member $495,  Non-member $615,  University Members $375,*  Student/Outreach Members $255
• After 7 March 2022:  Member $545,  Non-member $665,  University Members $425,*  Student/Outreach Members $255

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
Bob Figarotta; Eric Humes, RQAP-GLP; Christy Mazzarisi; Danielle Metzger; Judith Zahora, PMP

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)
• Understand 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
Any Quality Professional who is involved in process improvement

Agenda

• Define the problem - What, How Much, Where & When
• Review Data to detect a "signal"
• Apply Root Cause Analysis
• Develop corrective action

 

6 — GEN 208: Managing a Quality Assurance Department (One-day, In person and virtual)

Sunday, 3 April 2022, 8:00 AM - 5:00 PM, PDT

Registration Rates

• By 7 March 2022:  Member $495,  Non-member $615,  University Members $375,*  Student/Outreach Members $255
• After 7 March 2022:  Member $545,  Non-member $665,  University Members $425,*  Student/Outreach Members $255

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
Jackie Bushong, RQAP-GCP; Dawn Niccum, RQAP-GCP; Karin Rezzonico; Erin Rosenbaum
Description
Management of a QA department requires skills beyond a deep knowledge of regulations and compliance. Managers must think strategically to ensure the needs of the company and their direct reports are effectively administered.

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

• Describe the role of the QA Manager in a pharmaceutical company.
• Explain tools utilized in team management.
• Discuss the role of the QA Manager as part of the senior leadership team.

Target Audience
Current and future QA Managers

Agenda

1. Introduction
2. Overview of the QA Role
3. Effective Communication
4. Management Tools
5. Quality Management Reports
6. Managing Resources 
7. Forecasting & Budgets
8. Change Management Principles

 

7 — GCP 201: Hot Topics & Industry Trends (One-day, In person and virtual)

Sunday, 3 April 2022, 8:00 AM - 5:00 PM, PDT

Registration Rates

• By 7 March 2022:  Member $495,  Non-member $615,  University Members $375,*  Student/Outreach Members $255
• After 7 March 2022:  Member $545,  Non-member $665,  University Members $425,*  Student/Outreach Members $255

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
Angela Bazigos; Wendy Charles; Chrissy Cochran, PhD (FDA); Pam Dellea-Giltner, RQAP-GCP; Glenda Guest, RQAP-GCP; Lee Truax-Bellows, RQAP-GCP

Description
This interactive workshop with FDA and expert industry speakers will focus on Auditing Block Chain Technologies in Clinical Research, updated information from FDA on Data Integrity Considerations, Inspection Preparation and Conduct, Auditing Clinical Study Reports, Story Boarding and Remote Audit/Technology. Simulations of a GCP Remote Audit and a GLP Remote Audit will be conducted to verify that a Remote Audit yields comparable results to an onsite audit.

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

• Discuss data integrity considerations
• Discuss current areas of risk and explain common shortcomings in audit trails in the context of block chain in clinical trials
• Describe the purpose for Story Boarding
• Plan for Clinical Study Report Audits
• Prepare for fully remote GCP/GLP audits.

Target Audience
This course is relevant to GCP auditors with moderate to advanced level of experience and an interest in emerging trends.

Agenda

• Welcome, Introductions
• A Blockchain is Not What it Seems: How to Audit Blockchain Technology Used in Clinical Research
• Tips for Inspection Preparation and Conduct Part I
• Break
• Tips for Inspection Preparation and Conduct Part 2
• New Frontiers in Auditing: Leveraging Technology Advances to Convert to Remote Audits
• Lunch
• An FDA Perspective on Data Integrity Considerations
• Story Boards – What They Are and Why We Use Them
• Break
• Auditing Clinical Study Reports
• Presenter Panel / Audience Q&A

 

8 — CAPA 201: CAPA Creation and Effectiveness - Beyond Training (One-day, In person only)

Monday, 4 April 2022, 8:00 AM - 5:00 PM, PDT

Registration Rates

• By 7 March 2022:  Member $495,  Non-member $615,  University Members $375,*  Student/Outreach Members $255
• After 7 March 2022:  Member $545,  Non-member $665,  University Members $425,*  Student/Outreach Members $255

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
Bob Figarotta; Eric Humes, RQAP-GLP; Christy Mazzarisi; Danielle Metzger; Judith Zahora, PMP

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

Target Audience
Any Quality individuals who are a part of change management activities. NOTE: 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

• 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

 

9 — GCP 301: Advanced GCP (One-day, In person and virtual)

Monday, 4 April 2022, 8:00 AM - 5:00 PM, PDT

Registration Rates

• By 7 March 2022:  Member $495,  Non-member $615,  University Members $375,*  Student/Outreach Members $255
• After 7 March 2022:  Member $545,  Non-member $665,  University Members $425,*  Student/Outreach Members $255

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, PhD (FDA); Pam Dellea-Giltner, RQAP-GCP; Glenda Guest, RQAP-GCP; Lee Truax-Bellows, RQAP-GCP

Description
This interactive course 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 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 GCP into their roles;
• understand and implement a quality management system approach into their roles.

Target Audience
GCP Auditors with at least 3 years experience

Agenda

• GCP Quality Management Systems From Regulator Perspective
• GCP Quality Management System (QMS) CAPAs From  Sponsor Perspective
• GCP QMS From an Auditing Perspective
• Auditing a Trial master File

 

 

10 — GLP 102: Lies, Deceit, and Drift: The Creation of the FDA GLPs and Why They Are Still Relevant Today (Half-day, In person and virtual)

Thursday 7 April 2022, 1:30 PM - 5:30 PM, PDT

Registration Rates

• By 7 March 2022:  Member $310,  Non-member $410,  University Members $225,*  Student/Outreach Members $145
• After 7 March 2022:  Member $370,  Non-member $470,  University Members $285,*  Student/Outreach Members $145

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
Steve Drzick, RQAP-GLP; Barb Munch; Kathy Newland

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:

• Understand the history behind the FDA GLP regulations
• Compare the deceptions and fraud to the regulations and Compliance Program
• Use relevant course material to 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, spanning from beginner to experienced professionals

Agenda

• History prior to 1970s, including early pharma issues
• 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.

 

11 — CSV 205: Over the River and Through Woods: Following the Audit Trail (Half-day, In person and virtual)

Thursday, 7 April 2022, 1:30 PM - 5:30 PM, PDT

Registration Rates

• By 7 March 2022:  Member $310,  Non-member $410,  University Members $225,*  Student/Outreach Members $145
• After 7 March 2022:  Member $370,  Non-member $470,  University Members $285,*  Student/Outreach Members $145

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
Randal Basinger, Lisa Fink, Joe Franchetti, Chris Meister, Amanda Ulrey, RQAP-GLP
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. Individuals attending the training will leave with a greater understanding of points to consider concerning audit trails and more confidence in how to find compliance and data integrity problems when viewing audit trails.

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

• Describe requirements for electronic audit trails
• Explain how both system logs and audit trails can be used to assess data integrity
• Analyze a variety of compliant and non-compliant audit trails
• Summarize gaps in compliance for example data based on audit trail review and recommend corrective actions.

Target Audience

• GLP, GCP, and GMP auditors responsible for reviewing and inspecting electronic instruments, equipment and system records and data
• Anyone responsible for data integrity in electronic systems

Agenda

• Introductions and Course Overview
• Data Integrity and Regulatory Requirements Overview, Q&A
• Managing the Audit Trail Review Process and Paper Records Compared to their Electronic Audit Trail Equivalent, Q&A
  (Topics covered include: who reviews them, where is this process defined, where do the audit trails go, how to manage extensive audit trails)
• Group work – Review of example audit trails and discussion
• Break Out One (Group Exercise 1), Q&A
• System Logs vs. Audit Trails, Q&A
• Audit Trails in Action
  (Topics include: audit trail use as a monitoring tool for data integrity and audit trails for analyzed data), Q&A
• Break Out Two (Group Exercise 2), Q&A
• Warning Letter review
• Break Out Three (Group Exercise 3), Q&A
• Discuss specific issues and questions submitted at the time of registration/Open Discussion

 

12 — General 104: The Three Cs of SOPs: Clear, Concise, and Compliant in a Regulatory Setting (Half-day, In person and virtual)

Thursday, 7 April 2022, 1:30 PM - 5:30 PM, PDT
 
Registration Rates

• By 7 March 2022:  Member $310,  Non-member $410,  University Members $225,*  Student/Outreach Members $145
• After 7 March 2022:  Member $370,  Non-member $470,  University Members $285,*  Student/Outreach Members $145

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
Joe Franchetti, Gina Tucker, Judy Zahora, PMP
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 this course participants will 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 with regard to SOPs and how they are used.

Target Audience
Anyone responsible for the life cycle and compliance of these key components of the Quality Management System. This course is applicable to GMP, GCP, GLP and GVP - both beginners and more experienced.

Agenda

• Section 1: Introduction
• Section 2: Understand the Purpose and Benefit of Effective SOPs
• Section 3: SOP on SOPs
• Section 4: Characteristics of Good SOPs
• Section 5: Art to Writing SOP Content
• Section 6: Relationship between Plan/Protocol, SOPs, and Data
• Section 7: Deviations
• Section 8: Awareness/Training
• Section 9: Why people don't use SOPs
• Section 10: Wrap up

 

13 — General 101: QA Consulting (Half-day, In person and virtual)

Thursday, 7 April 2022, 1:30 PM - 5:30 PM, PDT

Registration Rates

• By 7 March 2022:  Member $310,  Non-member $410,  University Members $225,*  Student/Outreach Members $145
• After 7 March 2022:  Member $370,  Non-member $470,  University Members $285,*  Student/Outreach Members $145

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, RQAP-GLP; Lisa Fink; Deanna Talerico, RQAP-GLP
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:

• 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

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 good QA Consultant

 

14 — GLP 104: Auditing Techniques (One-day, In person and virtual)

Friday, 8 April 2022, 8:00 AM - 5:00 PM, PDT

Registration Rates

• By 7 March 2022:  Member $495,  Non-member $615,  University Members $375,*  Student/Outreach Members $255
• After 7 March 2022:  Member $545,  Non-member $665,  University Members $425,*  Student/Outreach Members $255

RQAP re-registration units: 8.00 GLP or non-GCP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenters
Sara Rybak, Gina Tucker

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

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

• Understand the regulatory requirements for FDA GLP QA, including high-level EPA/OCED GLP differences
• Understand 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
13. Conducting Internal Facility and External Vendor Audits
14. Hosting Sponsor/Regulatory Audits

 

15 — GLP 105: Introduction to FDA GLP Bioresearch Monitoring Compliance Program (One-day, In person and virtual)

Friday, 8 April 2022, 8:00 AM - 5:00 PM, PDT

Registration Rates

• By 7 March 2022:  Member $495,  Non-member $615,  University Members $375,*  Student/Outreach Members $255
• After 7 March 2022:  Member $545,  Non-member $665,  University Members $425,*  Student/Outreach Members $255

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
Barb Munch, Eric Pittman (FDA), Lori Wright, RQAP-GLP

Description
This course 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 how to conduct their GLP inspections of firms.

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

• Understand how the FDA uses the Compliance Program to perform inspections
• Apply the GLP Compliance Program information to build compliant processes
• Manage an FDA Inspection and respond to a 483
• Understand 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. Along with Inspection Real Life Examples & Lessons Learned and Discussion Topics

 

CANCELED - 16 — GCP 205: Dos and Don’ts of GCP Regulatory Inspection Interviews (One-day, In person only)

 

17 — GCP 206: GCP vendor risk‐based qualification and management (Virtual only)

Monday, 11 April 2022, 10:00 AM - 2:30 PM, EDT

Registration Rates

• By 7 March 2022:  Member $310,  Non-member $410,  University Members $225,*  Student/Outreach Members $145
• After 7 March 2022:  Member $370,  Non-member $470,  University Members $285,*  Student/Outreach Members $145

RQAP re-registration units: 4.00 GCP or non-GLP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenter
Kamila Novak

Description
This course provides an overview of GCP vendor collaboration life cycle. It focuses on key areas, including risk-based GCP vendor qualification, oversight, re-qualification, and end of collaboration as well as key documentation in each area needed for inspection readiness.

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

• Implement a fitting risk assessment of various GCP vendors.
• Develop an adequate GCP vendor oversight plan.
• List necessary documents as evidence for risk-based GCP vendor qualification and oversight expected by regulatory inspectors.

Target Audience
QA persons involved in vendor / supplier qualification, re-qualification. Anyone involved in GCP vendor oversight.

Agenda

1. GCP vendor life cycle
2. Qualification of GCP vendors
3. Basic documents and information to be obtained
4. Is your Vendor Qualification Questionnaire fit for purpose?
5. Risk Assessment 
6. Vendor score card
7. Qualification audit
8. Vendor contracting and onboarding
9. Vendor Oversight Plan and associated documents
10. Re-qualification
11. End of collaboration
12. Are you ready for inspections?
13. Discussion, Q & A

 

* University staff who are SQA members — Select the University rate when registering.