September 2016 Quality College
The September 2016 Quality College was held Tuesday through Thursday, 27-29 September 2016, followed by a Special Symposium on Friday, 30 September 2016 just outside Seattle, WA, USA. The Symposium was co-sponsored by the Pacific Regional Chapter of the Society of Quality Assurance (PRCSQA). Below is a list of courses that were held with links to course descriptions.
Tuesday, 27 September 2016
1-History Behind the FDA GLPs (1/2 day) - 27 September 2016, 8:00 AM - 12:00 PM
2-Good Clinical Practice: Understanding the Basics (1 and 1/2 days) - 27 September 2016, 8:00 AM - 5:00 PM; 28 September 2016, 8:00 AM - 12:00 PM
4-Business Continuity and Disaster Recovery (1/2 day) - 27 September 2016, 1:00 PM - 5:00 PM
Wednesday, 28 September 2016
2-Good Clinical Practice: Understanding the Basics (1 and 1/2 day) - 27 September 2016, 8:00 AM - 5:00 PM; 28 September 2016, 8:00 AM - 12:00 PM
5-Basic Training: Good Laboratory Practice (2 days) - 28 September 2016, 8:00 AM - 29 September 2016, 5:00 PM
6-Auditing Software and Data Providers with a Focus on Cloud Services (1 day) - 28 September 2016, 8:00 AM - 5:00 PM
7-CAPA Day One: Problem Definition - Beyond Human Error (1 day - this is day one of a two day course) - 28 September 2016, 8:00 AM - 5:00 PM
8-Pharmacovigilance for QA (1/2 day) - 28 September 2016, 1:00 PM - 5:00 PM
Thursday, 29 September 2016
5-Basic Training: Good Laboratory Practice (2 days) - 28 September 2016, 8:00 AM - 29 September 2016, 5:00 PM
9-GCP Beyond the Basics: Quality Management in the Clinical Study Environment (1 day) - 29 September 2016, 8:00 AM - 5:00 PM
10-Data Quality/Data Integrity: Can You Trust the State of Your Data? (1 day) - 29 September 2016, 8:00 AM - 5:00 PM
11: CAPA Day Two: CAPA: Creation and Effectiveness - Beyond Training (Across GxPs) (1 day - this is day two of a two day course. Attendees must attend CAPA Day One or have a strong background in RCA) - 29 September 2016, 8:00 AM - 5:00 PM
Friday, 30 September 2016
Special Symposium: A Changing Future for QA Professionals
Friday, 30 September 2016, 8:00 AM – 5:00 PM
Cosponsored by the Pacific Regional Chapter of the Society of Quality Assurance
Featuring discussion of the Notice of Proposed Rule Making (NPRM) to amend the FDA GLPs