Speakers: Lisa Helmonds, Vice President, MWA Consulting, Inc.
Organizers: 
Date: 10/24/2017
Time: 8:30-12:00
Registration fee (USD): Regular: $125; Academic: $75; For unemployed or students: $25; For major-sponsor rep (incl lunch): $0; For vendor-show reps: $25;
Location: SF Bay Area: Foster City Crowne Plaza
Major Sponsor: 
Vendor show vendors registered to date: (2)MicroConstants; PHARMout Laboratories
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 Laboratory Practices (GLP) regulations, the importance of the regulations, key definitions, areas covered by the GLPs, 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 GLP regulations.

8:45-9 am     PBSS Welcome & Workshop Overview

9-9:30 am     History of GLP Regulations

9:30-9:45 am    Areas Covered by GLPs

9:45-10 am    Key Definitions

10-10:15 am     Break & Vendor Show

10:15-11:15 am     Important Aspects of GLPs

• Subpart A: General Provisions
• Subpart B: Organization and Personnel
• Subparts C & D: Facilities and Equipment
• Subpart E: Testing Facilities Operations
• Subpart F: Test and Control Articles
• Subpart G: Protocol
• Subpart J: Records and Reports
• Subpart K: Disqualification

11:15 -11:30 am     FDA Actions and Misconduct

11:30-12 pm     Q & A