PBSS Workshop Workshop Good Laboratory Practices (GLPs): Fundamentals Regulatory Trends and Best Practices-2017-11-24

Event Information
Event Name: 
PBSS Workshop Workshop Good Laboratory Practices (GLPs): Fundamentals Regulatory Trends and Best Practices
Event Date: 
11/24/2017 - 8:30am
Event Location: 
SF Bay Area: Foster City Crowne Plaza
Event Details
Event Type: 
Event Details: 

PBSS, Friday, Nov. 24, 2017

Event: Workshop Good Laboratory Practices (GLPs): Fundamentals, Regulatory Trends and Best Practices
Speakers: Lisa Helmonds, Vice President, MWA Consulting, Inc.
Date and Time: 10/24/2017, 8:30-12:00
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
Location: SF Bay Area: Foster City Crowne Plaza
Registration fee (USD): Regular: $125; Academic: $75; For unemployed or students: $25; For major-sponsor rep (incl lunch): $0; For vendor-show reps: $25;
Registration: http://www.PBSS.org
Registration deadline: 10/22/2017 (it will close sooner if the seating cap is reached)

Event Description
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.

Speaker Bio
Lisa Helmonds has over 30 years of experience in Manufacturing and Quality Assurance in the pharmaceutical, biotechnology and medical device industries. She has extensive GXP knowledge, has held positions as a manufacturing chemist and QA manager/director as an FTE and as a consultant with several startups and large companies such as Syva, Syntex, Roche Bioscience, Alza, Shire, Gilead, along with many others and she understands the challenges facing the industry. She holds a BS in Zoology and minor in Chemistry from the University of Rhode Island and an MBA from Santa Clara University. She is currently Vice President of MWA Consulting, Inc. where she provides consulting services to MWA clients.