SQA Quality College

Virtual Courses held 16-30 September 2024

 

Course Descriptions

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

 

GEN 111 — Critical Thinking by Design (one half day, virtual)

Wednesday, 25 September 2024, 10:00 AM - 2:30 PM EDT

 
Registration Rates

• By 26 August 2024:  Member $400,  Non-member $530,  University/Government $290*,  Student/Outreach Members $185
• After 26 August 2024:  Member $465,  Non-member $595,  University/Government $355*,  Student/Outreach Members $185

      Register Online
    
RQAP re-registration units: 4 nonGCP|nonGLP
Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenter(s)

Tony Jones, Rita Hattemer-Apostel

Description

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

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

• Apply a straightforward and practical framework for critical thinking, as acquired through interactive exercises, discussions, and idea-sharing with fellow course participants, leading to a fresh perspective on problem-solving.
• Distinguish between appropriate critical thinking approaches, enabling them to effectively address both simple and complex situations with greater confidence and precision.
• Utilize a diverse array of lenses and tools to enhance critical thinking, providing them with valuable resources for analyzing and approaching problems in their professional endeavors.

Target Audience

All experience-levels of QA (and other) professionals who wish to expand their ability to apply critical thinking to quality and compliance problems.

Agenda

1. The Art of Critical Thinking
   • Introduction to Critical Thinking
   • Time and Focus
   • Lenses and Tools
   • A Model for Critical Thinking
2. The Critical Thinking Process
   • Zooming-In and Zooming-Out
   • Understanding "What's in the Water?" (culture, systems, complexity)
   • Deciding and Acting
   • Useful Lenses and Tools
3. Scenarios to Challenge Thinking
   • Scenario-Based Learning
   • Analyzing Real-World Scenarios
   • Group Discussions
   • Interactive Problem-Solving
4. Course Conclusion and Reflection

Level
Basic

GEN 216 — A Compliance Tool You Can Personalize and Implement (one half day, virtual)

Tuesday, 17 September 2024, 10:00 AM - 2:30 PM EDT

 
Registration Rates

• By 26 August 2024:  Member $400,  Non-member $530,  University/Government $290*,  Student/Outreach Members $185
• After 26 August 2024:  Member $465,  Non-member $595,  University/Government $355*,  Student/Outreach Members $185

        Register Online
 
RQAP re-registration units: 4 nonGCP|nonGLP
Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenter(s)

Jackie Torfin

Description

This course will explain and define the compliance metric and provide you with an easy-to-build example tool that you can utilize with any current system—electronic or paper-based. Attendees will be asked to bring their own (cleansed or example) data, and we will work to build a few example compliance risk tools to present to the class.  (The risk tool will be provided electronically to attendees for use). 

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

• Explain the difference between quality metrics and compliance metrics 
• Understand how metrics relate to compliance risk
• Understand the value of knowing and tracking your compliance risk

Target Audience
Organizational leaders who need to measure their compliance level and need to communicate this to their executive or management teams. This can apply to GLP, GMP, or GCP and, ideally, to all. It levels the playing field. 
  
Agenda

1. Quality Metrics vs. Compliance Metrics
2. How to Look at Compliance Risk
3. Building the Risk Tool
4. Using our data to populate the tool/share with the class
5. Showing the power of the tool over time/conclusion

Level
Intermediate/Advanced

GEN 217— Essentials of Change Management (one half day, virtual)

Friday, 20 September 2024, 10:00 AM - 2:30 PM EDT

 
Registration Rates

• By 26 August 2024:  Member $400,  Non-member $530,  University/Government $290*,  Student/Outreach Members $185
• After 26 August 2024:  Member $465,  Non-member $595,  University/Government $355*,  Student/Outreach Members $185

        Register Online
 
RQAP re-registration units: 4 nonGCP|nonGLP
Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenter(s)

Mojisola Komolafe , Nene Oche

Description

This concise course offers a foundational understanding of change management, focusing on key theories, strategies, and practices. It equips participants with essential skills to manage and lead change initiatives effectively within organizations. The course includes practical tools to handle resistance, communicate changes, and ensure successful adoption of change.

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

• Grasp the fundamentals and importance of change management.
• Analyze and apply key change management theories and models.
• Develop strategic plans for change and communicate change effectively to stakeholders.
• Implement change effectively within an organization.
• Manage resistance and foster support.

Target Audience
QA/QM Officers and Team Leads
  
Agenda

• 10:00 AM - 10:05 AM: Settle-ins and Introductions
  • Course introduction
  • Opening poll / Baseline quiz
• 10:05 AM - 10:40 AM: Introduction to Change Management
  • Definition and importance of change management
  • Types of change: transformational, incremental, remedial, developmental
  • Role and responsibilities of a change manager
• 10:40 AM - 11:25 AM: Change Management Theories and Models
  • Overview of fundamental Change Management Models
  • Questions / Discussions
  • Case Study Analysis: Analysis of a brief case study on a company using Kotter’s 8-Step Model
• 11:30 AM – 12:10 PM: Preparing for and Communicating Change
  • Developing a change management plan
  • Crafting key messages and managing stakeholder expectations
  • Breakout Discussion: Develop a communication plan for a given change scenario.
• 12:10 PM - 12:40 PM: Implementing Change
  • Leadership styles and their impact on change
  • Building and empowering a change management team
• 12:40 PM - 1:10 PM: Lunch Break
• 1:15 PM – 2:00 PM: Managing Resistance and Sustaining Change
  • Case Study Analysis: General Electric’s Two-Decade Transformation Under the Leadership of Jack Welch
  • Understanding and addressing resistance to change
  • Techniques for building support and engaging stakeholders
• 2:00 PM - 2:30 PM: Course Close out
  • Key takeaways / recap
  • Q & A
  • Closing poll / End of Course quiz
  • Course evaluation and feedback

Level
Basic/Intermediate

 

GCP 209 — Inspection Management: Risk-based Clinical Trial Site Inspection by NMPA (Chinese HA) (one half day, virtual)

Monday, 23 September 2024, 8:00 AM - 12:30 PM EDT

Developed by Members of the CQAF (China Quality Assurance Forum)

 
Registration Rates

• By 26 August 2024:  Member $400,  Non-member $530,  University/Government $290*,  Student/Outreach Members $185
• After 26 August 2024:  Member $465,  Non-member $595,  University/Government $355*,  Student/Outreach Members $185

        Register Online
 
RQAP re-registration units: 4 GCP|nonGLP
Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenter(s)

Cathy Liu, Hannah Chen, Sean Xu, Emma Hu, Theresa Wang

Description

Since the reform of the drug and medical device review and approval system was launched in 2015, great changes have taken place in the field of drug supervision in China. The supervision of drug clinical trials in China has gradually changed from GCP certification before implementation of drug clinical trials to supervision of the whole process. On 01 Jan 2022, NMPA launched the work procedures for initiation of drug registration inspections. Nowadays, clinical trial site inspections have become common and important for NDAs in China. Speakers will discuss key elements of the approach and procedures for NMPA site inspections, share their experience on current focused areas and how to best manage the inspections, and use common inspection finding metrics to help participants better plan their clinical trials for NDAs in China.

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

• Tell their peers about the risk-based approach for NMPA to initiate clinical trial site inspections.
• Be an expert on the procedures and current focused areas for NMPA site inspections
• Lead an inspection management team to prepare and facilitate NMPA site inspections
• Use QbD approach to plan their clinical trials in China through analyzing the common finding metrics for NMPA site inspections

Target Audience
GCP QA/QC professionals
GCP QA consultants
Clinical Development personnel in sponsors/CROs who have products in NDA submissions to NMPA

Agenda

1. Risk-based approach for NMPA to initiate clinical trial site inspections
2. Procedures and current focused areas for NMPA site inspections
3. Prepare and facilitate NMPA site inspections
4. Common finding metrics for NMPA site inspections

Level
Intermediate 

GCP 210 — Operational and Compliance Considerations for Investigational Drug Services (one half day, virtual)

Friday, 27 September 2024, 10:00 AM - 2:30 PM EDT

 
Registration Rates

• By 26 August 2024:  Member $400,  Non-member $530,  University/Government $290*,  Student/Outreach Members $185
• After 26 August 2024:  Member $465,  Non-member $595,  University/Government $355*, Student/Outreach Members $185

        Register Online
 
RQAP re-registration units: 4 GCP|nonGLP
Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenter(s)

Aurea M. Flores

Description

The course is divided in two sections: Investigational Drug Services explains the requirements for pharmacy services as part of the clinical trial team; Pharmacy versus Outsourcing dives into the operational and regulatory differences between the two. In both sessions, we will go over the review process as part of auditing responsibilities

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

• Understand the role and responsibilities of the principal investigator/designee/pharmacist as part of the clinical trial team
• Describe clinical trial regulatory requirements and best practices related to investigational pharmacy procedures
• Understand how the Investigational Plan directs investigational pharmacy operations
• Understand differences between investigational drug compounding and manufacturing
• Understand the differences between 503A and 503B facilities
• Describe best practices for 503A and 503B facilities
• Describe 503A and 503B operations review process

Target Audience
QA professionals auditing investigational pharmacies and outsourcing facilities  

Agenda

1. Investigational Drug Services Session
   • Role and responsibilities regarding investigational drugs
   • Regulatory requirements
   • Best practices and investigational pharmacy SOPs
   • Investigational Plan
2. Pharmacy Department vs. Outsourcing Facility Session
   • Definitions: Compounding vs. Manufacturing operations
   • Differences between licensed pharmacy departments and outsourcing manufacturing facilities supporting clinical trials
   • Best practices and SOPs for licensed pharmacy departments and outsourcing manufacturing facilities supporting clinical trials
   • Operational review processes for licensed pharmacy departments and outsourcing manufacturing facilities supporting clinical trials

Level
Basic/Intermediate/Advanced

 

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

Wednesday, 18 September 2024, 10:00 AM - 2:30 PM EDT

Thursday, 19 September 2024, 10:00 AM - 2:30 PM EDT

 
Registration Rates

• By 26 August 2024:  Member $640, Non-member $800, University/Government $485*, Student/Outreach Members $330
• After 26 August 2024:  Member $705, Non-member $865, University/Government $550*, Student/Outreach Members $330

        Register Online
 
RQAP re-registration units: 8 GLP|nonGCP
Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenter(s)

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 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*

Level
Basic 

GLP 106 — FDA GLP Preamble Overview (one half day, virtual)

Thursday, 26 September 2024, 10:00 AM - 2:30 PM EDT

 
Registration Rates

• By 26 August 2024:  Member $400,  Non-member $530,  University/Government $290*,  Student/Outreach Members $185
• After 26 August 2024:  Member $465,  Non-member $595,  University/Government $355*,  Student/Outreach Members $185

        Register Online
 
RQAP re-registration units: 4 GLP|nonGCP
Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenter(s)

Barb Munch, Steve Rogenthien, Greg Furrow, Eric Pittman, FDA 

Description

This course is intended to review the 1978, 1984, and 1987 FDA GLP Preambles, in sequence by regulation.  The goal of the class is to teach attendees how to use the Preambles as a tool, such that these documents can be used to help resolve regulatory questions.  New documents have been created that contain each preamble along with the subsequent changes.  Many important points of the preambles will be discussed, including examples of how to apply the intent as provided by the FDA Commissioner.  The class is encouraged to bring their own regulatory questions for discussion.

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

• Recognize the legal importance of preambles
• Identify some of the most important preambles
• Interpret the preambles to apply when issues arise

Target Audience
FDA GLP QA Auditors and Managers, from intermediate to experienced, as well as Study Directors, Principal Investigators, and Testing Facility Management.  

Agenda

1. Course Objectives
2. Review of Course Materials
3. Federal Rule Making
4. Preamble Use - Class Activity
5. Preamble Use - Presenter Examples
6. Attendee Open Question Time

Level
Basic 

GLP 205 — Moving GLP Compliance from Paper to Digital (two half days, virtual)

Tuesday, 24 September 2024, 10:00 AM - 2:30 PM EDT

Wednesday, 25 September 2024, 10:00 AM - 2:30 PM EDT

 
Registration Rates

• By 26 August 2024:  Member $640, Non-member $800, University/Government $485*, Student/Outreach Members $330
• After 26 August 2024:  Member $705, Non-member $865, University/Government $550*, Student/Outreach Members $330

        Register Online
 
RQAP re-registration units: 8 GLP|nonGCP
Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenter(s)

Jackie Torfin, Brendan Hyland

Description

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

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

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

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

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

Agenda

• Part 1 – Context and Motivation
  • What does going Digital actually mean?
  • Relevant workflows
  • Pros and Cons
• Part 2 – Modern GLP Compliance
  • How do we move on from the “old GLP” ideas
  • The latest FDA, EPA and OECD thoughts
• Part 3 – Developing Requirements
  • What are the GLP requirements for digital data?
  • Where does validation and Part 11 come into play?
  • What are the requirements for data archiving & retention?
• Part 4 – Approach and Strategy
  • What are some ways we can approach this transformation?
  • Building a phased implementation approach

Level
Intermediate/Advanced

 

CSV 104 — AI Unleashed: Fun and Exciting Tools, Tips, Tricks, and Techniques for Life Science! (one half day, virtual)

Monday, 16 September 2024, 10:00 AM - 2:30 PM EDT

 
Registration Rates

• By 26 August 2024:  Member $400,  Non-member $530,  University/Government $290*,  Student/Outreach Members $185
• After 26 August 2024:  Member $465,  Non-member $595,  University/Government $355*,  Student/Outreach Members $185

        Register Online
 
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.

Presenter(s)

Steve Thompson, "Tommi" Trudy Papson, Jacqueline Bushong

Description

AI has exploded on the scene, with Generative AI being the catalyst in 2022. Now almost everyone is talking about it, but who really understands what's really going on in this field of technology? How does this impact life science? Is it safe to use? Or do we need to put guardrails in place now to avoid a potential catastrophe? This course will provide an understanding of AI in general along with generative AI and Artificial General Intelligence; consider it AI 101. Attendees will gain insight on how AI is already being used today. Next, attendees will raise awareness of the risks imposed by use of AI and ethical considerations we need to start talking about, today. Finally, a basic blueprint will be presented so attendees can take the next steps in embracing AI, safely and ethically, while not stifling advancements in this field of technology. 

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

• Provide understanding of AI/ML/Generative AI
• Highlight applications used today in life science
• Identify future trends and applications
• Discuss ethics, risk, and potentials for misuse and possible catastrophes
• Blueprint on how we can move forward in a compliant manner and leverage, not throttle, this technology

Target Audience
QA, Regulatory Affairs, and Regulators at all levels of experience. Auditors. IT professionals in life science. GxP folks. This is a general awareness of AI to help life sciences properly apply, use, and regulate this technology, so many can benefit. 
 
Agenda

1. Introduction (10 min)
2. AI 101 (45 min)
3. Interactive Exercise (10 min)
4. AI Use in Life Science (45 min)
5. BREAK (10 min)
6. Predicting the Future (Trends & Applications) (45 min)
7. Risk and Ethics for AI (45 min)
8. Next Steps: How to Apply AI in Your Organization (30 min)

Level
Basic 

 

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