Speakers

GMP Quality Management for OTC Manufacturers

Wednesday, 3/10 11:15 a.m. - 12:00 p.m.

Welcome and Orientation

Monday, 3/8 2:00-2:15 p.m.

Case Studies from GMP Inspections

Wednesday, 3/10 8:15-9:00 a.m.

Addressing Nitrosamine Concern in Pharmaceuticals – USP New General Chapter <1469>

Wednesday, 3/10 4:00-4:45 p.m.

GMP Inspection Recognition and Reliance Initiatives

Tuesday, 3/9 10:00-10:45 a.m.

Update from the Office of Regulatory Affairs

Tuesday, 3/9 8:30-9:15 a.m.

Health Canada Inspection Trends and Case Studies

Tuesday, 3/9 1:45-2:30 p.m.

Sterility Assurance for ATMPs: From Isolators Back to Grade A

Tuesday, 3/9 4:00-4:45 p.m.

Development of a Remote Auditing Program

Tuesday, 3/9 10:45-11:30 a.m.

Update on CFR 9 for Vaccine Manufacturing

Thursday, 3/11 9:00-9:45 a.m.

CMC of New Animal Drugs

Thursday, 3/11 8:15-9:00 a.m

Supplier Qualifications – USP General Information Chapter in Development

Thursday, 3/11 1:00-1:45 p.m.

Combating Counterfeit Pharmaceuticals with Technology

Wednesday, 3/10 1:45-2:30 p.m.

OTC Monograph Reform in the 2020 CARES Act

Wednesday, 3/10 10:30-11:15 a.m.

Impact of COVID-19 on the Pharmaceutical Supply Chain

Tuesday, 3/9 3:15-4:00 p.m.

Pharmaceutical Innovation: Challenges & Opportunities from an Industry Perspective

Thursday, 3/11 11:15 a.m.-12:00 p.m.

Update from CBER

Monday, 3/8 2:30-3:15 p.m.

Data Analytics: Holistic approach to implement the digital plant

Thursday, 3/11 4:00-4:45 p.m.

(Some) Legal and Regulatory Issues to Consider Relating to Quality Agreements

Thursday, 3/11 1:45-2:30 p.m.

BREXIT and GMP Inspections

Wednesday, 3/10 9:00-9:45 a.m.

Analytical Challenges for Nitrosamine Method Development and Testing in Pharmaceuticals

Wednesday, 3/10 3:15-4:00 p.m.

Update from CDER

Tuesday, 3/9 1:00-1:45 p.m.

Post Approval Change Management

Wednesday, 3/10 1:00-1:45 p.m.

Welcome and Orientation

Monday, 3/8 2:00-2:15 p.m.

Laboratory and OOS Investigations

Thursday, 3/11 3:15-4:00 p.m.