SQA April 2021 Quality College

A Virtual Event

In light of the situation regarding COVID-19, the April 2021 Quality College was a fully virtual event held in conjunction with the 37th SQA Annual Meeting that was held virtually, 12-15 April 2021. Quality College took place the following two weeks, 19-23 April 2021 and 26-29 April 2021.

A three-day course, Basic Concepts in Computer Validation, was taught in advance of the Annual Meeting, 2-4 March 2021.

 

Course Schedule

Tuesday-Thursday | 2-4 March 2021

CSV 101: Basic Concepts in Computer System Validation
This course has separate registration from the other Quality College courses. Follow the link above for details.
 

Monday | 19 April 2021

10:00 AM – 12:00 PM EDT
1 – GCP 202: Hot Topics & Industry Trends
2 – GLP 104: Auditing Techniques
3 – GMP 101: GMP Foundations

12:00 – 12:30 PM EDT | BREAK

12:30 PM – 2:30 PM EDT
1 – GCP 202: Hot Topics & Industry Trends, continued
2 – GLP 104: Auditing Techniques, continued
3 – GMP 101: GMP Foundations, continued
 

Tuesday | 20 April 2021

10:00 AM – 12:00 PM EDT
1 – GCP 202: Hot Topics & Industry Trends, continued
2 – GLP 104: Auditing Techniques, continued
3 – GMP 101: GMP Foundations, continued

12:00 – 12:30 PM EDT  | BREAK

12:30 PM – 2:30 PM EDT
1 – GCP 202: Hot Topics & Industry Trends, continued
2 – GLP 104: Auditing Techniques, continued
3 – GMP 101: GMP Foundations, continued
 

Wednesday | 21 April 2021

10:00 AM – 12:00 PM EDT
4 – GCP 301: Advanced Training
5 – GEN 205: QA and Supply Chain: 6 Pathways to Explore in Order to Enhance This Relationship
6 ‐ GLP 102: Lies, Deceit, and Drift: The Creation of the FDA GLPs and Why They Are Still Relevant Today

12:00 – 12:30 PM EDT  | BREAK 

12:30 PM – 2:30 PM EDT
 4 – GCP 301: Advanced Training, continued
5 – GEN 205: QA and Supply Chain: 6 Pathways to Explore in Order to Enhance This Relationship, continued
6 ‐ GLP 102: Lies, Deceit, and Drift: The Creation of the FDA GLPs and Why They Are Still Relevant Today, continued
 

Thursday | 22 April 2021

10:00 AM – 12:00 PM EDT
4 – GCP 301: Advanced Training, continued
7 – GEN 107: New Skills for Quality Professionals
8 – GMP 201: Effective GMPs
9 – GEN 206: Steering Through Regulatory Biomarker Qualification Expectations CANCELED

12:00 – 12:30 PM EDT  | BREAK 

12:30 PM – 2:30 PM EDT
4 – GCP 301: Advanced Training, continued
7 – GEN 107: New Skills for Quality Professionals, continued
8 – GMP 201: Effective GMPs, continued
  

Friday | 23 April 2021

10:00 AM – 12:00 PM EDT
 7 – GEN 107: New Skills for Quality Professionals, continued
8 – GMP 201: Effective GMPs, continued
10 – GLP 105: Introduction to FDA GLP Bioresearch Monitoring Compliance Program

12:00 – 12:30 PM EDT  | BREAK 

12:30 PM – 2:30 PM EDT

7 – GEN 107: New Skills for Quality Professionals, continued
8 – GMP 201: Effective GMPs, continued
10 – GLP 105: Introduction to FDA GLP Bioresearch Monitoring Compliance Program, continued
 

 

Monday | 26 April 2021

10:00 AM – 12:00 PM EDT
11 – GEN 108: Quality Assurance Roles in the Drug Development Process
12 – CAPA 101: CAPA Creation and Effectiveness: Beyond the Basics
13 – GMP 302: Critical Controls for Aseptic Processing

12:00 – 12:30 PM EDT  | BREAK 

12:30 PM – 2:30 PM EDT

11 – GEN 108: Quality Assurance Roles in the Drug Development Process, continued
12 – CAPA 101: CAPA Creation and Effectiveness: Beyond the Basics, continued
13 – GMP 302: Critical Controls for Aseptic Processing, continued
 

Tuesday | 27 April 2021

10:00 AM – 12:00 PM EDT
11 – GEN 108: Quality Assurance Roles in the Drug Development Process, continued
12 – CAPA 101: CAPA Creation and Effectiveness: Beyond the Basics, continued
13 – GMP 302: Critical Controls for Aseptic Processing, continued

12:00 – 12:30 PM EDT  | BREAK 

12:30 PM – 2:30 PM EDT

11 – GEN 108: Quality Assurance Roles in the Drug Development Process, continued
12 – CAPA 101: CAPA Creation and Effectiveness: Beyond the Basics, continued
13 – GMP 302: Critical Controls for Aseptic Processing, continued
 

Wednesday | 28 April 2021

10:00 AM – 12:00 PM EDT

14 – CSV 205: Over the River and Through Woods: Following the Audit Trail
15 – GMP 303: Chemistry and Manufacturing Controls (CMC) Post Approval Changes ‐ Integral to Continued Process Improvement  CANCELED

12:00 – 12:30 PM EDT  | BREAK 

12:30 PM – 2:30 PM EDT

14 – CSV 205: Over the River and Through Woods: Following the Audit Trail, continued
15 – GMP 303: Chemistry and Manufacturing Controls (CMC) Post Approval Changes ‐ Integral to Continued Process Improvement  CANCELED

 

Thursday | 29 April 2021

10:00 AM – 12:00 PM EDT
16 – GEN 101: QA Consulting
17 – GEN 104: The Three Cs of SOPs: Clear, Concise, and Compliant in a Regulatory Setting

12:00 – 12:30 PM EDT  | BREAK 

12:30 PM – 2:30 PM EDT

16 – GEN 101: QA Consulting, continued
17 – GEN 104: The Three Cs of SOPs: Clear, Concise, and Compliant in a Regulatory Setting, continued
 

Looking for basic training in GCPs or GLPs?

SQA has its basic courses in GCP and GLP available in on-demand online formats, available to you at your convenience:

Other on-demand courses are also available on the topics of GLP Study Director and Principal Investigator Training, Introduction to 21 CFR Part 11, and Introduction to Writing Effective Compliant GLP SOPs at sqa.org/learn.