SQA Quality College

Virtual Courses held 11-21 September 2023

 

Course Descriptions

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

DEV 203 — Medical Device Testing: An Overview of Biocompatibility Tests (one half day, virtual)

Thursday, 21 September 2023, 10:00 AM - 2:30 PM EDT

 
Registration Rates
  • By 21 August 2023:  Member $400,  Non-member $530,  University/Government $290,*  Student/Outreach Members $185
  • After 21 August 2023:  Member $465,  Non-member $595,  University/Government $355,*  Student/Outreach Members $185
        Register Online
 
RQAP re-registration units: 4.00 GLP or non-GCP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenter(s)

Michael Brady, Vanessa M. Dubay, Felice Randi LaMadeleine, Christopher Parker

Description

This course will provide an overview of medical device testing and FDA recommendations/requirements. Lessons will touch upon some of the basic tests (e.g., In Vivo tests, In Vitro tests), genetic toxicology, and chemical characterization. This course will also discuss the reasons for and results of testing.

Objectives
At the end of the course, the participants shall be able to:
  • Provide information about various medical device tests
  • List reasons for administering the tests
  • Describe expected endpoints
Target Audience
Quality Assurance professionals who support the medical device industry and want to learn more about the tests conducted per the FDA's consensus standards, ISO 10993 series, and others
 
Agenda
  1. Overview of medical device testing
  2. In Vivo tests
  3. In Vitro tests
    • Cytotoxicity
    • Hemocompatibility
    • Genotoxicity
  4. Chemical Assays
Level
Basic/Intermediate

GEN 212 — How to Use QMS to Inspire Your Client/Customer (one half day, virtual)

Monday, 11 September 2023, 10:00 AM - 2:30 PM EDT

 
This course has been cancelled.

GEN 213 — QMS Optimization: A Guide for Small Companies (one half day, virtual)

Wednesday, 20 September 2023, 10:00 AM - 2:30 PM EDT

 
Registration Rates
  • By 21 August 2023:  Member $400,  Non-member $530,  University/Government $290,*  Student/Outreach Members $185
  • After 21 August 2023:  Member $465,  Non-member $595,  University/Government $355,*  Student/Outreach Members $185
        Register Online
 
RQAP re-registration units: 4.00 non-GCP or non-GLP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenter(s)

Kamila Novak, Melanie Willis, Judy Zahora

Description

Ensuring quality is managed well and building a QMS fit-for-the-purpose can be a challenging task for small companies, particularly for start-ups with limited financial resources, manpower, and experience. At the extreme, they may over-engineer the QMS, license solutions that better fit much larger companies with incomparable manpower, or neglect it. These actions have a significant impact on their viability and future. In this course, we will discuss common pitfalls, explore the QMS building process, and offer tips to both build a functional, scalable quality management system that can grow with participants' organizations and get buy-in from the organization's personnel, top management included.

Objectives
At the end of the course, the participants shall be able to:
  • Identify common pitfalls, such as over-engineering the system that increases the risk of deviations from the designed processes and procedures or designing a system too weak, increasing the risk of audit / inspection / due diligence findings
  • Design a fit-for-purpose QMS meeting quality and business objectives
  • Prepare justification of the proposed system
  • "Sell" the system to personnel to support compliance
Target Audience
QA professionals working in small or starting pharma, biotech, or medical device companies; GLP labs or CROs who are responsible to build or re-build/improve a fit-for-the-purpose QMS in their organizations
 
Agenda
  1. Not like this! Two bad examples – too much and too little
  2. Fit-for-purpose QMS key considerations - GMP, GLP, GCP specifics
  3. Is it fit-for-purpose? Business and compliance drivers
  4. I'm starting from scratch! Common constraints & what to do
  5. I need to re-build it completely! How to manage change
  6. Getting management buy-in
  7. Getting personnel buy-in
  8. Implementation steps
  9. Does it work? Assessment of effectiveness
  10. Continuing improvement
Level
Intermediate

GEN 214 — Risk Based Approach vs. Risk Management, and Determination of Acceptable Risk (one half day, virtual)

Tuesday, 19 September 2023, 10:00 AM - 2:30 PM EDT

 
Registration Rates
  • By 21 August 2023:  Member $400,  Non-member $530,  University/Government $290,*  Student/Outreach Members $185
  • After 21 August 2023:  Member $465,  Non-member $595,  University/Government $355,*  Student/Outreach Members $185
        Register Online
 
RQAP re-registration units: 4.00 non-GCP or non-GLP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenter(s)

Steve Gompertz

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 confuse that concept with the more formal Risk Management (RM) process, which is different but related. At its simplest, RM is a subset of RBA used when formal risk analysis, evaluation, and control is necessary. However, most situations only require an awareness of the risks and how to mitigate them, i.e., applying risk-based thinking or an RBA. This course will explain the differences between the two concepts and demonstrate how to avoid faulty thinking when assessing acceptable risk.


Objectives
At the end of the course, the participants shall be able to:
  • Differentiate between a Risk-Based Approach (RBA) and Risk Management (RM)
  • Describe why a calculated Risk Priority Number (RPN) can't be used to determine risk acceptability
  • Describe why "high" risks can still be acceptable
  • Aggregate individual risks into overall device/product risk
  • Establish clear benefit/risk rationale
Target Audience
Quality System Manager/Directors/VPs, Quality Engineers
 
Agenda
  1. What is Risk?
  2. Risk-Based Thinking vs. Risk Management
  3. Determining Acceptable Risk vs. Calculating an RPN
  4. Aggregating Individual Risks (Comparing Apples & Oranges)
  5. Making Benefit/Risk Analysis Less Subjective
Level
Intermediate/Advanced

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

Tuesday-Wednesday, 12-13 September 2023, 10:00 AM - 2:30 PM EDT

 
Registration Rates
  • By 21 August 2023:  Member $640,  Non-member $800,  University/Government $485,*  Student/Outreach Members $330
  • After 21 August 2023:  Member $705,  Non-member $865,  University/Government $550,*  Student/Outreach Members $330
        Register Online
 
RQAP re-registration units: 8.00 GLP or non-GCP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenter(s)

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:
  • Identify the regulatory requirements for FDA GLP QA, including high-level EPA/OCED GLP differences
  • Describe regulatory inspection process for nonclinical laboratory facilities, including a review of the Bioresearch Monitoring Program (BIMO) Compliance Program Guidance Manual (CPGM)
  • Effectively communicate FDA GLP requirements to management and study personnel
  • Audit protocols, laboratory records, electronic data and final reports for compliance with regulations
  • Identify compliance gaps and effectively communicate gaps and recommendations for correction via an audit report
  • Use knowledge and skills obtained through collaborative group exercises to enhance technical proficiency
Target Audience
This course is a comprehensive introduction or refresher training for all personnel working within an FDA Good Laboratory Practice facility
 
Agenda
  1. Course Overview
  2. Quality Assurance Responsibilities
  3. CPGM Overview
  4. Protocol Audits
  5. Process and Phase Inspections
  6. Facility Records
  7. Remote Auditing
  8. Electronic Records
  9. Study Data (including electronic data, and audit trails)
  10. Report Audit
  11. Writing and Resolving Audit Reports
  12. Quality Assurance Statements
  13. Conducting Internal Facility and External Vendor Audits*
  14. Hosting Sponsor/Regulatory Audits*

     *will be included if time permits

Level
Beginner

GLP 204 — Ensuring Quality Good Laboratory Practices from Start to Finish for FDA and EPA (two half days, virtual)

Thursday-Friday, 14-15 September 2023, 10:00 AM - 2:30 PM EDT

 
Registration Rates
  • By 21 August 2023:  Member $640,  Non-member $800,  University/Government $485,*  Student/Outreach Members $330
  • After 21 August 2023:  Member $705,  Non-member $865,  University/Government $550,*  Student/Outreach Members $330
        Register Online
 
RQAP re-registration units: 8.00 GLP or non-GCP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenter(s)

JoAnn Boyd

Description

This course will explore start to finish aspects of a good GLP program to meet FDA, client, and other regulatory requirements. Participants will learn about new programs developed with client insight and the Study Director's responsibility within the program to avoid FDA 483s.

The course will identify critical aspects of the GLPs regarding inventory, custody, training, equipment, materials, inspections, and procedures and discuss potential issues to avoid prior to problems. The training will also cover the required technical materials an individual must provide to the Study Director to avoid potential audit findings.

Objectives
At the end of the course, the participants shall be able to:
  • Assess material and sample inventory and custody
  • Describe the equipment qualification inspections required for GLP compliance
  • Describe QAU regulatory requirements as a team effort
  • List the documentation and evidence needed to ensure that regulatory requirements have been fulfilled
  • Provide regulators, clients and assessor with evidence in a timely manner that meets regulation
Target Audience
New and experienced Good Laboratory Practice personnel. The training includes GLP and potential laboratory cGMP requirements for new programs
 
Agenda
  1. Study Director and Staff Training
  2. Study Director Responsibilities
  3. Evaluation and Concepts of GLP Regulations
  4. Protocols and SOPs
  5. Material and Sample Custody, Handling and Storage
  6. Controlled Documents Recommended and Archives
  7. Quality Assurance Unit Responsibilities and Actions
  8. Quality Tools for Continuous Improvement
  9. Critical Phases and Inspections Required
  10. Study Preparation and Conduct
  11. Equipment Qualification and Verification
  12. Software Validation to 21 CFR Part 11
  13. Final Reports
  14. Preparation for Regulatory Audits
Level
Intermediate/Advanced

PUBHLTH 102 — Nutrivigilance: A Crying Need Worldwide (presented by the Nigeria Regional Chapter of SQA) (one half day, virtual)

Monday, 18 September 2023, 8:00 AM - 12:30 PM EDT

 
Registration Rates
  • By 21 August 2023:  Member $400,  Non-member $530,  University/Government $290,*  Student/Outreach Members $185
  • After 21 August 2023:  Member $465,  Non-member $595,  University/Government $355,*  Student/Outreach Members $185
        Register Online
 
RQAP re-registration units: 4.00 non-GCP or non-GLP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenter(s)

Chioli Pascal Chijioke, Fintan Ekochin, Chika Isabelle Ndiokwelu, Laura Okpala, Clement Ugwoke

Description

The course covers all relevant areas pertaining to food and drink safety and quality, including GMP aspects. Participants will learn about prevalence of adulteration with illegal additives. The course will also consider the undesirability and chronic toxicity of processed commercial foods, food and drink additives and their role in immune dysfunction and chronic diseases. Studies on acute toxicities and food poisoning will be included.


Objectives
At the end of the course, the participants shall be able to:
  • Explain and describe the dire need for much more extensive monitoring and research into food safety and quality
  • Assess current studies and reports on food and drink toxicity (illegal adulteration, microbial contamination)
  • Interpret research studies and reports bearing on the toxicity of processed commercial foods and food/drink additives and their role in immune dysfunction and chronic diseases
Target Audience
All QA professionals who have an interest in, or responsibility for, food safety and quality clinicians with an interest in diet and health
 
Agenda
  1. The dire need for much more extensive monitoring and research into food safety and quality
  2. Studies and reports on acute food toxicity, food poisoning (chemical, microbial)
  3. Studies and reports on food and drink toxicity (illegal adulteration, microbial contamination)
  4. Research studies and reports bearing on the chronic toxicity of processed commercial foods, food and drink additives and their role in immune dysfunction and chronic diseases
Level
Beginner

 

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