Speakers: Marion Weinreb, President, MWA Consulting, Inc.
Organizers: 
Date: 10/24/2017
Time: 13:00-17:30
Registration fee (USD): Regular: $125; Academic: $75; For unemployed or students: $25; For vendor-show reps: $25; For major-sponsor rep (incl lunch): $0;
Location: SF Bay Area: Foster City Crowne Plaza
Major Sponsor: (1)Pacific BioLabs
Vendor show vendors registered to date: (5)Alcami; BioDuro; MabPlex; Nitto Avecia Pharma Services, Inc.; PerkinElmer
Registration: https://www.PBSS.org
Registration deadline:10/20/2017  (it will close sooner if the seating cap is reached)

About the Topic

This workshop will include a discussion on the history of Good Manufacturing Practices (GMP) regulations from R&D through Commercialization, the importance of the regulations, key definitions, areas covered by the GMPs, a review of the regulations, examples of misconduct and, potential FDA actions.  After completing this workshop, participants should be able to understand the origin, purpose, and expectations of the GMP regulations.

12:45-12:55 pm

• PBSS Welcome & Workshop Overview
• History of Drug Regulations
• Basis of GMPs

12:55-2:00 pm

• CGMPs on a Continuum
  • Development vs Commercial Compliance
  • Review of Clinical Failures and Commercial Recalls

2:00-2:10 pm

• Major Sponsor Presentation

2:10-2:25 pm

• Break & Vendor Show

2:25-3:40 pm

• Current FDA Expectations and Focus
  • Data Integrity
  • Quality Metrics
  • Quality by Design

3:40-4:00 pm

• Break and Vendor Show

4:00-5:00 pm

• Oversight of CMOs

5:00-5:20pm

• Q & A