SQA Quality College

In Person: 6-7 and 10-11 April 2025 in Orlando, FL, USA
Virtual: 16 April 2025

 

Course Descriptions

Please note that individual courses will offer various RQAP Re-registration units, depending on the topic and length of the course. Units will be added to course descriptions soon and unit categories will include GCP/Non-GLP and GLP/Non-GCP.

 

Course Category: GEN

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

Thursday, 10 April 2025, 1:30 PM - 5:30 PM EDT

 
Registration Rates
  • By 13 January 2025:  Member $380,  Non-member $510,  University/Government $280*,  Student/Outreach Members $175
  • 13 January - 3 March 2025:  Member $415,  Non-member $545,  University/Government $300*,  Student/Outreach Members $190
  • After 3 March 2025: Member $480,  Non-member $615,  University/Government $365*,  Student/Outreach Members $190
      Register Online
    
RQAP re-registration units: 4.00 non-GCP | non-GLP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenters

Jacqueline Bushong, Robin Guy, Deanna Talerico, Laurie Taddonio

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, contracts, 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.
  • Define the qualities of a consultant.
  • Explain sponsor (your client) expectations, needs and methods of interactions.
  • Describe what laboratories/CROs expect from you.

Target Audience
This course is targeted to those QA Professionals who want to learn more about consulting or have a desire to pursue consulting as a career.
 
Agenda
  1. Introduction
  2. Meeting expectations of your client (the Sponsor)
  3. What the CROs expect from you as a consultant
  4. Setting up and running your consulting company
  5. How to be a valuable QA Consultant

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

Thursday, 10 April 2025, 1:30 PM - 5:30 PM EDT

 
Registration Rates
  • FREE for all SQA Members
  • By 13 January 2025:  Non-member $510,  University/Government $280*
  • 13 January - 3 March 2025:  Non-member $545,  University/Government $300*
  • After 3 March 2025: Non-member $615,  University/Government $365*
      Register Online
    
RQAP re-registration units: 4.00 non-GCP | non-GLP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenters

Cheryl McCarthy, Kim Fraizer, Tracy Henthorn, Joe Franchetti, Joe Whittemore, Lori Wright, Karrel Joseph

Description

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

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

We have leaders in many stages of their career as part of SQA. This course has some new content for 2025 so even if you have attended this course in the past, it continues to offer interactive and fun group activities on leadership concepts. Join us for this session to meet and network with past, current and future SQA leaders and join the conversation.

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


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

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

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GEN 103: The Biologics Super Highway (half-day, in-person) -- Cancelled

Thursday, 10 April 2025, 1:30 PM - 5:30 PM EDT

 

GEN 111: Critical Thinking by Design (half-day, virtual)

Wednesday, 16 April 2025, 10:00 AM - 2:00 PM EDT

 
Registration Rates
  • By 13 January 2025:  Member $380,  Non-member $510,  University/Government $280*,  Student/Outreach Members $175
  • 13 January - 3 March 2025:  Member $415,  Non-member $545,  University/Government $300*,  Student/Outreach Members $190
  • After 3 March 2025: Member $480,  Non-member $615,  University/Government $365*,  Student/Outreach Members $190
       Register Online
 
RQAP re-registration units: 4.0 non-GCP | non-GLP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenter(s)

Rita Hattemer-Apostel, Tony Jones

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.
  • Use different lenses and tools to enhance critical thinking, providing 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. Critical Thinking by Design
  2. The Critical Thinking Process
  3. Scenarios to Challenge Thinking
  4. Course Conclusion and Reflection

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NEW! GEN 112: Establishing a Process Approach in a Regulated QMS (half-day, in-person)

Thursday, 10 April 2025, 1:30 PM - 5:30 PM EDT

 
Registration Rates
  • By 13 January 2025:  Member $380,  Non-member $510,  University/Government $280*,  Student/Outreach Members $175
  • 13 January - 3 March 2025:  Member $415,  Non-member $545,  University/Government $300*,  Student/Outreach Members $190
  • After 3 March 2025: Member $480,  Non-member $615,  University/Government $365*,  Student/Outreach Members $190
     Register Online
    
RQAP re-registration units: 4 non-GCP | non-GLP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenters

Sahithi Datla, Steve Gompertz

Description
Quality Management Systems are often architected as a collection of activities reflecting a kind of checklist approach to meeting the requirements of applicable regulations and standards. However, those regulations and standards expect something different; interconnected activities establishing processes within and across the QMS. This course will clarify those expectations and provide methods for achieving the true intent of the regulations and standards, and more importantly, an effective QMS that provides value (business benefit) beyond just compliance.

Objectives
At the end of the course, the participants shall be able to: 
  • Describe the intent and concept of applying a process approach to a QMS.
  • Demonstrate practical methods for applying systems thinking to QMS activities to connect them as processes.
  • Explain how connecting activities into processes facilitates identification of more effective process performance monitoring.
Target Audience
  • At the Basic level, participants may just be getting started in establishing a QMS and need to understand this concept before going down the wrong path.
  • At the Intermediate level, participants may already be working with a QMS where the process approach was not properly considered and need to understand how to correct that.
  • At the Advanced level, participants may be leading organizations where the QMS similarly didn't incorporate the process approach and need to influence the organization to embrace it now.
Agenda
  • Introductions
  • What is a Process Approach?
  • Applying Systems Thinking to Connecting Activities into Processes
  • Hands-on Exercise
  • Identifying Meaningful Process Performance Metrics
  • Wrap-Up & Questions

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NEW! GEN 219: QA Consulting; Building a Sustainable Business (half-day, in-person)

Friday, 11 April 2025, 8:00 AM - 12:00 PM EDT

 
Registration Rates
  • By 13 January 2025:  Member $380,  Non-member $510,  University/Government $280*,  Student/Outreach Members $175
  • 13 January - 3 March 2025:  Member $415,  Non-member $545,  University/Government $300*,  Student/Outreach Members $190
  • After 3 March 2025: Member $480,  Non-member $615,  University/Government $365*,  Student/Outreach Members $190
      Register Online
    
RQAP re-registration units: 4 non-GCP | non-GLP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenters

Suheila Abdul-Karrim, Robin Guy, Chris Both, Pam Dellea-Giltner

Description
 Consulting 101 provided valuable information needed to establish a consulting practice, including legal considerations, insurance, contracts, and key attributes for a successful consultant. Having made the decision to launch the consulting practice, there are additional considerations to help ensure that your practice can not only survive but thrive.

Consulting 219 provides helpful information and insight on how to determine if you have a successful business model established. Included in this session will be pointers on how to establish appropriate pricing models; managing project loads, timing and schedules; establishing and managing customer expectations and assessing client satisfaction; effective marketing and sales strategies; and outsourcing considerations.

Consulting 219: Building a Sustainable Business is a half day course taught by successful consultants that will share the benefits of their years of experience in the industry, addressing the needs of clients across the spectrum of regulated activities including GLP, GCP and GMP and related activities.

Objectives
At the end of the course, the participants shall be able to:
  • Establish a service pricing model that meets the consultants financial requirements;
  • Develop pragmatic approaches to sales and marketing services offered;
  • Explain how to appropriately manage time necessary for running a business;
  • Develop processes that ensure clear communication for managing customer expectations and assess customer satisfaction;
  • Establish mechanisms for managing a fluctuating workload, including outsourcing and insourcing.
Target Audience
QA Consultants that have launched their business and have at least 1 year of active consulting experience. This course is not targeted for individuals who are considering becoming a consultant (See GEN 101 QA Consulting) or those who work as independent contractors for consulting firms.
 
Agenda
  • Time management
  • Managing client expectations
  • Marketing and sales
  • Outsourcing
  • Pricing considerations

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Course Category: GCP

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

Sunday, 6 April 2025, 8:00 AM - Monday, 7 April 2025, 5:00 PM EDT

 
Registration Rates
  • By 13 January 2025:  Member $990,  Non-member $1135,  University/Government $725*,  Student/Outreach Members $465
  • 13 January - 3 March 2025:  Member $1060,  Non-member $1225,  University/Government $785*,  Student/Outreach Members $500
  • After 3 March 2025: Member $1140,  Non-member $1310,  University/Government $865*,  Student/Outreach Members $500
      Register Online
    
RQAP re-registration units: 16.00 GCP | non-GLP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenters

Jenny O'Brien, Chris Both, Cheryl McCarthy, Dawn Niccum, Cecilia Matos-Rosa, Nadine Jones

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

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GCP 201: Hot Topics and Industry Trends (one-day, in-person)

Monday, 7 April 2025, 8:00 AM - 5:00 PM EDT

 
Registration Rates
  • By 13 January 2025:  Member $615,  Non-member $765,  University/Government $465*,  Student/Outreach Members $315
  • 13 January - 3 March 2025:  Member $660,  Non-member $825,  University/Government $500*,  Student/Outreach Members $340
  • After 3 March 2025: Member $725,  Non-member $890,  University/Government $565*,  Student/Outreach Members $340
      Register Online
    
RQAP re-registration units: 8.00 GCP | non-GLP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenters

Dawn Niccum, Cheryl McCarthy, Paul Fenton-Carter, Karin Rezzonico

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

Objectives
At the end of the course, the participants shall be able to: 
  • Support the development of a diversity plan
  • Describe the updates in ICH E6 (R3)
Target Audience
Experienced Quality Assurance professionals, 3+ years of experience, with an interest in learning more about new topics/trends in clinical research.
 
Agenda
  • FDA Mandate for Diversity Plans
  • Decentralized Clinical Trials - latest trends
  • Recent FDA notices of proposed rulemaking (2) and the recent informed consent guidance
  • Review of audit trails - how does this demonstrate oversight
  • Preparing for the ICH E6 R3
  • Advanced auditing techniques of the TMF

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GCP 209: Challenges in Auditing Clinical Labs: Is CLIA Certification Enough? (one-day, in-person)

Friday, 11 April 2025, 8:00 AM - 5:00 PM EDT

 
Registration Rates
  • By 13 January 2025:  Member $615,  Non-member $765,  University/Government $465*,  Student/Outreach Members $315
  • 13 January - 3 March 2025:  Member $660,  Non-member $825,  University/Government $500*,  Student/Outreach Members $340
  • After 3 March 2025: Member $725,  Non-member $890,  University/Government $565*,  Student/Outreach Members $340
      Register Online
    
RQAP re-registration units: 8 GCP | non-GLP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenters

Kim Frazier, Dawn Niccum, Jeanine Pitts

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

Objectives
At the end of the course, the participants shall be able to: 
  • Describe the limitations of CLIA certification in ensuring regulatory compliance for clinical trials
  • Identify the critical areas of focus during the audits of clinical laboratories
  • Ensure clinical laboratories meet regulatory requirements for the processing of samples for the purposes of a clinical trial
Target Audience
QA professionals tasked with qualifying GCP laboratory facilities for use in clinical trials.
 
Agenda
  • Introduction
  • CLIA Overview
  • GCLP Overview
  • EU Guidance
  • Other Regulations
  • Exercise
  • Wrap Up

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

Sunday, 6 April 2025, 8:00 AM - 5:00 PM EDT

 
Registration Rates
  • By 13 January 2025:  Member $615,  Non-member $765,  University/Government $465*,  Student/Outreach Members $315
  • 13 January - 3 March 2025:  Member $660,  Non-member $825,  University/Government $500*,  Student/Outreach Members $340
  • After 3 March 2025: Member $725,  Non-member $890,  University/Government $565*,  Student/Outreach Members $340
      Register Online
    
RQAP re-registration units: 8.00 GCP | non-GLP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenters

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

Description
This interactive course will provide experienced GCP QA professional with advanced GCP QA tools to incorporate into how they perform audits, training and GCP support within their roles. This course has been designed to provide best practices and audience participation activities and 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.
  • Describe and implement a quality management system approach into their roles.
Target Audience
GCP Auditors with 3 or more years of experience.
 
Agenda
  1. GCP Quality Management Systems (QMS) from a Regulatory Perspective
  2. GCP QMS CAPAs from a Sponsor Perspective
  3. Auditing a Trial Master File
  4. Best Practice or Regulations?
  5. Auditing a Clinical Study Report

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Course Category: GLP

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

Sunday, 6 April 2025, 8:00 AM - Monday, 7 April 2025, 5:00 PM EDT

 
Registration Rates
  • By 13 January 2025:  Member $990,  Non-member $1135,  University/Government $725*,  Student/Outreach Members $465
  • 13 January - 3 March 2025:  Member $1060,  Non-member $1225,  University/Government $785*,  Student/Outreach Members $500
  • After 3 March 2025: Member $1140,  Non-member $1310,  University/Government $865*,  Student/Outreach Members $500
      Register Online
    
RQAP re-registration units: 16.00 GLP | non-GCP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenters

Theresa Donegan, Greg Furrow, Beth Moulaison, Barb Munch, Karen Waetjen, Tom Purdue, Gina Tucker, Johanna Mazlo

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

Objectives
At the end of the course, the participants shall be able to: 
  • Describe the regulatory requirements for nonclinical laboratory facilities, equipment, personnel, methods, practices, records and controls to assure Management of compliance or report the lack thereof.
  • Identify compliance gaps in the overall quality system of a facility and suggest improvements based upon regulatory requirements.
  • Effectively communicate the requirements of EPA and FDA GLPs and identify topical differences between FDA and EPA requirements.
  • Interpret and apply GLP requirements using a variety of resources.
  • Use the knowledge obtained by completing the training exercises to increase effectiveness in current role.
Target Audience
All levels of GLP experience.
 
Agenda
  1. Basic GLP training introduction
  2. Landmark cases in the development of GLPs
  3. Organization of GLPs
  4. Scope and Definitions
  5. Shall or Should (Legal Terminology)
  6. Contracts & Inspections
  7. Organization and Personnel
  8. Facilities
  9. Equipment
  10. SOPs, Reagents & Solutions, Animal Care
  11. Test and Control Articles
  12. Protocol
  13. Conduct of Nonclinical Laboratory Studies
  14. Reporting
  15. Storage, Retrieval, and Retention
  16. OECD Principles and Mutual Acceptance of Data
  17. Electronic Records

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

Thursday, 10 April 2025, 1:30 PM - 5:30 PM EDT

 
Registration Rates
  • By 13 January 2025:  Member $380,  Non-member $510,  University/Government $280*,  Student/Outreach Members $175
  • 13 January - 3 March 2025:  Member $415,  Non-member $545,  University/Government $300*,  Student/Outreach Members $190
  • After 3 March 2025: Member $480,  Non-member $615,  University/Government $365*,  Student/Outreach Members $190
      Register Online
    
RQAP re-registration units: 4.00 GLP | non-GCP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenters

Brooke Coblentz, Megan Gaylor

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

Objectives
At the end of the course, the participants shall be able to: 
  • Summarize the basics of GLP Archiving.
  • Describe electronic record archiving.
Target Audience
GLP Auditors that audit archives, GLP Archivist and Archive staff, Study Directors and Test Facility Management.
 
Agenda
  1. What Is a GLP -Compliant Archive?
  2. The Why:
  3. The How:
  4. The What Else?
  5. The Who:
  6. The When:
  7. The Where:
  8. Questions

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GLP 105: Introduction to FDA GLP Bioresearch Monitoring Compliance Program (half-day, in-person) -- CANCELLED

Friday, 11 April 2025, 1:00 PM - 5:00 PM EDT

 

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

Friday, 11 April 2025, 8:00 AM - 12:00 PM EDT

 
Registration Rates
  • By 13 January 2025:  Member $380,  Non-member $510,  University/Government $280*,  Student/Outreach Members $175
  • 13 January - 3 March 2025:  Member $415,  Non-member $545,  University/Government $300*,  Student/Outreach Members $190
  • After 3 March 2025: Member $480,  Non-member $615,  University/Government $365*,  Student/Outreach Members $190
      Register Online
    
RQAP re-registration units: 4.00 GLP | non-GCP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenters

Greg Furrow, Barb Munch, Steve Rogenthien

Description
This course is intended to review the 1978, 1984, and 1987 FDA GLP Preambles, in sequence by regulation. 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: 
  • Explain the legal importance of preambles
  • Define some of the most important preambles
  • Describe 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
  • Course Objectives
  • Review of Course Materials
  • Federal Rule Making
  • Preamble Use, Class Activity
  • Preamble Use, Presenter Examples
  • Attendee Open Question Time

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GLP 302: Quality Assurance for New Approach Methodologies (NAMs) (half-day, in-person)

Monday, 7 April 2025, 1:00 PM - 5:00 PM EDT

 
Registration Rates
  • By 13 January 2025:  Member $380,  Non-member $510,  University/Government $280*,  Student/Outreach Members $175
  • 13 January - 3 March 2025:  Member $415,  Non-member $545,  University/Government $300*,  Student/Outreach Members $190
  • After 3 March 2025: Member $480,  Non-member $615,  University/Government $365*,  Student/Outreach Members $190
      Register Online
    
RQAP re-registration units: 4.0 non-GCP | non-GLP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenters

Amanda Ulrey, Mark Seaton, FDA (virtual), J Hickman (virtual), Chris McAleer, Melanie Willis (assisting)

Description
The field of regulatory toxicology and nonclinical safety testing is changing due in part to revisions in federal laws that mandate efforts to replace whole animal studies. These laws have supported the emergence of new in vitro technologies, also called New Approach Methodologies (NAMs), such as organ and human-on-a-chip, and novel in silico tools, for safety assessment in the regulatory setting. To meet the needs of the changing landscape, quality assurance (QA) professionals will need to expand theirs kills to properly audit these methods not only within the context of regulatory studies, but also prior to regulatory use, when the focus of the work must be on establishing the credibility and reliability of NAMs for use in regulated studies. This continuing education course is designed to introduce QA professionals to the principles and practices described in OECD guidance document 286: Good In Vitro Method Practices (GIVIMP).The GIVIMP guidance provides a supplement to good laboratory practice(GLP) regulations that QA professionals can refer to when preparing to audit NAMs. GIVIMP principles also support NAM method development, with guidance intended to ensure that NAMs are based on strong science.

Objectives
At the end of the course, the participants shall be able to: 
  • List several ways to improve the quality of methodologies and studies using cells, tissues, and microphysiological systems as the test systems
  • Describe considerations important in assuring the quality of regulated in vitro work
  • Explain Good In Vitro Method Practices (GIVIMP)
  • Describe how GIVIMP can be applied outside of regulated work to support the integrity of NAMs
Target Audience
Quality Assurance auditors who wish to gain an understanding of how to audit non-animal based test methods. Anyone interested in improving the quality and data integrity of New Approach Methodologies(NAMs). It is helpful if participants have a good understanding of GLP regulations with 3 or more years of experience in this area.
 
Agenda
  • The course begins with an exploration of the foundational principles that underpin GIVIMP and its significance in maintaining high standards of quality for not just the performance of a study using one or more NAMs, but for the design, development, and implementation of NAMs.
  • Participants will gain insights into why GIVIMP was developed and where the application of GIVIMP principles are helpful in academic as well as industry laboratories.
  • Participants will work through the chapters of GIVIMP and discuss how well-known topics such as: roles and responsibilities; facility design; apparatus, material and reagents; test systems; test, reference and control items; standard operating procedures; performance of the method; reporting of results; and storage and retention of records and materials, relate to the development and use of NAMs.
  • Special attention will be given to those areas that differ from what is required for animal based studies and to those recommendations that differ from what is described in GLP regulations. A basic understanding of GLPs is required for this course.
  • Through practical examples and case studies, participants will understand how recommendations within GIVIMP can be implemented within a laboratory to support reliable and reproducible science.

The course aims to empower QA professionals with the knowledge and tools necessary to navigate the complexities of in vitro methods, ensuring that the highest standards of quality and reliability are met in any lab.


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Course Category: GMP

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

Sunday, 6 April 2025, 8:00 AM - 5:00 PM EDT

 
Registration Rates
  • By 13 January 2025:  Member $615,  Non-member $765,  University/Government $465*,  Student/Outreach Members $315
  • 13 January - 3 March 2025:  Member $660,  Non-member $825,  University/Government $500*,  Student/Outreach Members $340
  • After 3 March 2025: Member $725,  Non-member $890,  University/Government $565*,  Student/Outreach Members $340
      Register Online
    
RQAP re-registration units: 8.00 non-GLP | non-GCP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenters

Edward Armstrong, Megan Callan, Steve Rogenthien

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

Objectives
At the end of the course, the participants shall be able to: 
  • Describe the purpose of the GMP regulations and how the regulations developed over time
  • Apply the regulations in their work
Target Audience
Quality Assurance professionals with 0 - 2 years of GMP QA experience.
 
Agenda 
  1. Good Manufacturing Practices
  2. History of the US Food and Drug Administration
  3. Quality Management Systems
  4. Good Documentation Practices
  5. Electronic Records
  6. Change Control
  7. Deviation/Non-Conformance
  8. Plant Operations
  9. Laboratory Operations
  10. Regulatory Compliance
  11. Specialty Topics
    1. Medical Device
    2. Phase Appropriate GMPs

Information on Interactive Exercises:

  1. Let’s Build an SOP
  2. Let’s Document a Change Control
  3. Let’s Document a Deviation
  4. Let’s Receive Some Materials
  5. What’s Wrong With this Picture(s)?

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GMP 201: Effective GMPs (one-day, in-person)

Monday, 7 April 2025, 8:00 AM - 5:00 PM EDT

 
Registration Rates
  • By 13 January 2025:  Member $615,  Non-member $765,  University/Government $465*,  Student/Outreach Members $315
  • 13 January - 3 March 2025:  Member $660,  Non-member $825,  University/Government $500*,  Student/Outreach Members $340
  • After 3 March 2025: Member $725,  Non-member $890,  University/Government $565*,  Student/Outreach Members $340
      Register Online
    
RQAP re-registration units: 8.00 non-GCP | 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

Description
This comprehensive Good Manufacturing Practices (GMP) course is designed to provide participants with a thorough understanding of the essential principles and practices required to ensure the quality and safety of pharmaceutical products. The course covers a wide range of topics, from handling complaints to advanced analytical techniques, ensuring participants are well-equipped to manage and improve quality systems in a regulated environment.

Objectives
At the end of the course, the participants shall be able to: 
  • Demonstrate and explain the rational and application behind the GMP regulations.
Target Audience
Quality professional with 2 - 5 years of compliance experience.
 
Agenda

Key Topics:

  1. Complaints Management:
    • Understanding the importance of effective complaint handling.
    • Procedures for documenting and investigating complaints.
    • Implementing corrective and preventive actions (CAPA).
  2. Quality Risk Management (QRM):
    • Principles of risk management in the pharmaceutical industry.
    • Tools and techniques for risk assessment and mitigation.
    • Integrating QRM into quality systems.
  3. Out of Specification (OOS) and Trend Analysis:
    • Identifying and investigating OOS results.
    • Trend analysis for continuous improvement.
    • Regulatory expectations and best practices.
  4. Analytical Quality Requirements (AQR) Media:
    • Overview of AQR media and its applications.
    • Ensuring the quality and consistency of media used in testing.
  5. Basic Biologics and Aseptic Fill:
    • Fundamentals of biologics manufacturing.
    • Aseptic processing techniques and contamination control.
    • Regulatory requirements for biologics and aseptic fill.
  6. Advanced Analytical Techniques:
    • High-Performance Liquid Chromatography (HPLC)
    • Gas Chromatography (GC)
    • Mass Spectrometry (MSD)
    • Ultra-Performance Liquid Chromatography (UPLC)
    • Microbiological testing and stability studies.
  7. Equipment and Compendial Method Software Qualification:
    • Qualification and validation of equipment and software.
    • Ensuring compliance with compendial methods.
    • Metrology and calibration practices.
  8. Hosting U.S. Inspections:
    • Preparing for FDA and other regulatory inspections.
    • Best practices for hosting and managing inspections.
    • Responding to inspection findings and observations.
  9. Responding to Observations:
    • Effective strategies for addressing regulatory observations.
    • Developing and implementing corrective action plans.
    • Ensuring sustainable compliance.
  10. Quality Management Maturity (QMM):
    • Understanding the concept of QMM.
    • Assessing and improving quality management systems.
    • Achieving higher levels of quality maturity.

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GMP 301: Advanced GMP Topics (one-day, in-person)

Friday, 11 April 2025, 8:00 AM - 5:00 PM EDT

 
Registration Rates
  • By 13 January 2025:  Member $615,  Non-member $765,  University/Government $465*,  Student/Outreach Members $315
  • 13 January - 3 March 2025:  Member $660,  Non-member $825,  University/Government $500*,  Student/Outreach Members $340
  • After 3 March 2025: Member $725,  Non-member $890,  University/Government $565*,  Student/Outreach Members $340
      Register Online
    
RQAP re-registration units: 8 non-GCP | 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

Description
This course delves into the multifaceted world of quality assurance in the pharmaceutical and biotech industries. Covering regulatory guidelines, advanced therapies, and inspection hosting, this program is designed for professionals aiming to deepen their expertise in quality systems and compliance.

Objectives
At the end of the course, the participants shall be able to: 
  • Develop a thorough understanding of worldwide GMPs and ICH guidelines
  • Gain expertise in advanced therapeutic modalities and vaccines
  • Master analytical techniques for biopharmaceutical applications
  • Prepare for and successfully host international inspections
  • Implement robust quality systems and validation protocols
Target Audience
  • Quality Assurance professionals with 5+ years of experience in GMP, GCP, or GLP.
  • Quality assurance professionals, regulatory affairs specialists, validation experts, and anyone involved in the biopharmaceutical manufacturing process looking to enhance their knowledge and skills.
Agenda
  • Worldwide Good Manufacturing Practices (GMPs)
  • Overview of global GMP regulations
  • Comparison of regional GMP standards
  • Case studies on GMP implementation
  • ICH Q10 Pharmaceutical Quality System (PQS), ICH Q8 & Q11, ICH Q12
  • Comprehensive analysis of ICH guidelines
  • Implementation of Pharmaceutical Quality Systems
  • Strategies for lifecycle management
  • Site Master File (SMF) and Validation Master Plan (VMP)
  • Development and maintenance of SMFs
  • Crafting and executing VMPs
  • Compliance and inspection readiness
  • Advanced Topics: Gene and Cell-Based Therapies, Vaccines
  • Cutting-edge advancements in gene and cell therapies
  • Quality assurance in vaccine development
  • Regulatory considerations and challenges
  • Analytical Techniques: ICP OES, TOFMS, Viral RNA
  • Introduction to advanced analytical methods
  • Applications of ICP OES and TOFMS
  • Techniques for detecting and analyzing viral RNA
  • Process, Cleaning, and Hold Time Qualification
  • Process qualification and validation strategies
  • Cleaning validation protocols
  • Hold time studies and their importance
  • Non-Compendial Methods
  • Development and validation of non-compendial methods
  • Ensuring accuracy and reliability
  • Regulatory acceptance criteria
  • Hosting International Inspections
  • Preparing for international regulatory inspections
  • Best practices for hosting inspectors
  • Handling post-inspection follow-ups
  • Process Analytical Technology (PAT) and Post Approval Changes
  • Fundamentals of PAT and its role in quality assurance
  • Managing changes post-approval
  • Regulatory submissions for post-approval changes

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Course Category: Other

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

Sunday, 6 April 2025, 8:00 AM - Monday, 7 April 2025, 5:00 PM EDT

 
Registration Rates
  • By 13 January 2025:  Member $990,  Non-member $1135,  University/Government $725*,  Student/Outreach Members $465
  • 13 January - 3 March 2025:  Member $1060,  Non-member $1225,  University/Government $785*,  Student/Outreach Members $500
  • After 3 March 2025: Member $1140,  Non-member $1310,  University/Government $865*,  Student/Outreach Members $500
      Register Online
    
RQAP re-registration units: 16.00 GCP | GLP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenters

Bob Figarotta, Danielle Metzger, Christy Mazzarisi

Description
Fundamental to an effective CAPA program is the practical application of Root Cause Analysis (RCA) and developing an understanding of the root cause(s), contributing cause(s), and possible cause(s) of the issue/problem. Defining the problem - setting boundaries - is integral to enabling an effective RCA. This course will provide tools, insight and best practice to support continuous process improvement and enable sustained results by emphasizing approaches to defining the problem, analyzing the causal factors, and applying RCA tools to develop robust CAPA plans.

A common deficiency in many industry CAPA programs is a myopic RCA identifying human error and solely prescribing training as the preventive mitigation. By going beyond human error and training, the effective CAPA/EC program becomes a systematic assessment, focusing less on the individual and more on the process(es) in place (What about the process that allowed the issue to occur?) and the process quality control (What about the process that allowed the issue not to be detected?). Shifting the mindset from reactive to proactive thinking using risk management principles throughout the RCA lifecycle.

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

Day 1:

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

Day 2:

  • Review of Problem Definition and Root Cause Analysis
  • Group Refresher Root Cause Analysis
  • The Purpose of a CAPA
  • How to Facilitate CAPA Effectiveness
  • Group Practice (CAPA Steps 5-6)
  • Group Practice and Report
  • Fundamental Change through Trend Analysis and Process Improvement
  • QRM Principles
  • CAPA Systems
  • Group Scenario – CAPA Systems and Communication
  • Q&A

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

Sunday, 6 April 2025, 8:00 AM - 5:00 PM EDT

 
Registration Rates
  • By 13 January 2025:  Member $615,  Non-member $765,  University/Government $465*,  Student/Outreach Members $315
  • 13 January - 3 March 2025:  Member $660,  Non-member $825,  University/Government $500*,  Student/Outreach Members $340
  • After 3 March 2025: Member $725,  Non-member $890,  University/Government $565*,  Student/Outreach Members $340
      Register Online
    
RQAP re-registration units: 8.00 non-GCP | non-GLP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenters

Ann-Christin Becker, Dan McKay, Karen Ward, Larry Thomas, Vaska Tone

Description
This one-day course is a practical session on pharmacovigilance systems and PV auditing. Methods of auditing and key PV topics will be discussed. Numerous tips and best practices will be shared. Hands-on activities will be included to further engage the participants.

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

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RI 102: 5 C’s to respond to an FDA 483 (half-day, in-person)

Thursday, 10 April 2025, 1:30 PM - 5:30 PM EDT

 
Registration Rates
  • By 13 January 2025:  Member $380,  Non-member $510,  University/Government $280*,  Student/Outreach Members $175
  • 13 January - 3 March 2025:  Member $415,  Non-member $545,  University/Government $300*,  Student/Outreach Members $190
  • After 3 March 2025: Member $480,  Non-member $615,  University/Government $365*,  Student/Outreach Members $190
      Register Online
    
RQAP re-registration units: 4.0 GCP | GLP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenters

Edward Armstrong, Chris Both, Barb Munch

Description
FDA personnel will review the FDA Investigations Operations Manual (IOM), regarding GCP, GLP, and GMP establishment inspections. The IOM directs FDA Investigators how to conduct and report inspections, including authority to enter, inspectional procedures, and reporting. SQA members from industry will discuss differences and similarities between GCP, GLP, and GMP, when preparing for and hosting an FDA Inspection. Real-life examples of compliance issues will be presented, as well as a variety of scenarios with class participation with ways to respond, and ways not to respond, to an FDA Form 483. This class builds on GLP information presented in QC GLP-105, ‘Introduction to FDA GLP Bioresearch Monitoring Compliance Program’.

Objectives
At the end of the course, the participants shall be able to: 
  • Explain what to do when FDA identifies significant objectionable conditions and how to receive an FDA Form 483
  • Describe the FDA’s expectations regarding FDA Form 483 responses using the 5 C’s
  • Identify and prevent incomplete or unclear FDA Form 483 responses that could lead to a Warning Letter or Untitled Letter
  • Identify relevant records that a firm should provide with their FDA Form 483 responses
  • Develop internal processes and training to generate FDA Form 483 responses that meet all 5 C’s
Target Audience
  • GCP GLP GMPQA auditors
  • Study Directors
  • Test Facility Management
Agenda
  • How not to respond
  • Why was this class developed?
  • FDA 483 Myths
  • FDA Investigations Operations Manual (IOM)
  • Oh no, they found something!
  • 5 C’s – Clear, Concise, Compelling, Complete, Compliant
  • Oh no, there’s a Warning Letter!
  • Frequent FDA 483 Topics
  • FDA 483 Real Life Examples
  • Scenarios repeated, better ways how to respond
  • FDA References
  • Class Exercises #1 and #2

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

Monday, 7 April 2025, 8:00 AM - 5:00 PM EDT

 

DEV 204: Risk-Based Approach, Risk Management, & Risk Assessment: Misconceptions, Expectations, & Effective Application (half-day, in-person)

Monday, 7 April 2025, 8:00 AM - 12:00 PM EDT

 
Registration Rates
  • By 13 January 2025:  Member $380,  Non-member $510,  University/Government $280*,  Student/Outreach Members $175
  • 13 January - 3 March 2025:  Member $415,  Non-member $545,  University/Government $300*,  Student/Outreach Members $190
  • After 3 March 2025: Member $480,  Non-member $615,  University/Government $365*,  Student/Outreach Members $190
      Register Online
    
RQAP re-registration units: 4 non-GCP | non-GLP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenters

Steve Gompertz, Mark Swanson

Description
For years, regulations and standards have been increasing their focus on application of a Risk-Based Approach (RBA) to quality management. Unfortunately, many people have confused that concept with the more formal Risk Management (RM) process. The two are related, but different concepts. In this 1/2 day tutorial, participants will learn how RM is a subset of RBA, where RBA focuses on QMS process risks and RM focuses on product risks. RBA is more about creating awareness of process risks, i.e. - applying risk-based thinking . RM is the formal process of identifying, assessing, controlling, and monitoring product risk. Within RM, requirements for assessing risks are also frequently misunderstood due to attempts to simplify the process through a single tool to try to consolidate it into a simply calculation. Unfortunately, it doesn't work that way. The common approach of estimating severity and probability of harm don't actually provide the required indications of whether risks are acceptable and whether the product manufacturer has made adequate attempts to eliminate, lower, or maintain risk levels. This tutorial will explain those misconceptions, clarify what's really intended, and offer suggestions for how to achieve them. This will include discussions about benefit/risk analysis and aggregating individuals risks to determine the overall product risk.

Objectives
At the end of the course, the participants shall be able to: 
  • Describe the differences between Risk-Based Approach and Risk Management, when each is required, and how to implement them
  • Explain why a calculated Risk Priority Number (RPN) can't be used to determine risk acceptability nor demonstrate that risks have been reduced as low as reasonable practicable or as far as possible
  • Demonstrate how to aggregate individual risks into overall product risk
  • More clearly establish Benefit/Risk rationale
Target Audience
Anyone responsible for assessing or managing medical device risk, whether a novice or expert.
 
Agenda
  • Introductions
  • What are Risk, Risk-Based Approach, and Risk Management
  • Implementing a Risk-Based Approach
  • Fundamentals of Risk Management
  • Determining Risk Acceptability
  • Aggregating Individual Risks
  • Establishing Benefit/Risk Rationale
  • Wrap-Up / Final Questions

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