Course Schedule
Wednesday | 23 September 2020
9:00 AM – 1:00 PM EDT
1 – GCLP 101: An Introduction to GCLP
2 – GLP 104: Auditing Techniques
3 – GLP 102: Lies, Deceit, and Drift: The Creation of the FDA GLPs and Why They Are Still Relevant Today
1:00-2:00 PM EDT | BREAK | Optional virtual "break room" for networking and chatting
2:00 PM – 6:00 PM EDT
1 – GCLP 101: An Introduction to GCLP, continued
2 – GLP 104: Auditing Techniques, continued
4 – DEV 201: The Ventilator Diaries: Vendor Qualification and Management for Medical Device Imports during COVID-19
Thursday | 24 September 2020
9:00 AM – 1:00 PM EDT
5 – GMP 101: Basic Training: GMP History and Regulations
7 – GEN 107: New Skills for Quality Assurance Professionals
1:00-2:00 PM EDT | BREAK | Optional virtual "break room" for networking and chatting
2:00 PM – 6:00 PM EDT
5 – GMP 101: Basic Training: GMP History and Regulations, continued
6 – CSV 102: Auditing Agile Methodology in the Real World
Friday | 25 September 2020
9:00 AM – 1:00 PM EDT
8 – GLP 103: Basic GLP Archiving
10 – CSV 205: Over the River and Through Woods: Following the Audit Trail
11 – GMP 201: Foundations for GMP Quality and Compliance
1:00-2:00 PM EDT | BREAK | Optional virtual "break room" for networking and chatting
2:00 PM – 6:00 PM EDT
9 – GLP 203: Intermediate GLP Archiving
11 – GMP 201: Foundations for GMP Quality and Compliance, continued
Monday | 28 September 2020
9:00 AM – 1:00 PM EDT
12 – CSV 206: Implementing and Validating 21 CFR Part 11 Compliant e-Signatures
14 – GCP 301: Advanced Training
1:00-2:00 PM EDT | BREAK | Optional virtual "break room" for networking and chatting
2:00 PM – 6:00 PM EDT
13 – GEN 101: QA Consulting
14 – GCP 301: Advanced Training, continued
Tuesday | 29 September 2020
9:00 AM – 1:00 PM EDT
15 – GCP 202: Hot Topics & Industry Trends
16 – GEN 106: Auditor's Primer: Chromatography & Mass Spectrometry
1:00-2:00 PM EDT | BREAK | Optional virtual "break room" for networking and chatting
2:00 PM – 6:00 PM EDT
15 – GCP 202: Hot Topics & Industry Trends, continued