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Workshop

Good Laboratory Practices (GLPs): Fundamentals, Regulatory Trends and Best Practices


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: (4)Intertek; MicroConstants; PHARMout Laboratories; Sekisui XenoTech, LLC
Registration: http://www.PBSS.org
Registration deadline:10/22/2017  (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

 


About the Speakers

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.


2018-08-03, The New EMA Guideline and Evolving Expectations for Patient Safety in First-in-Human Clinical Trials: Keeping the Focus on the Science
2018-09-12, Antibody Drug Conjugates: Chemistry, Biology, Pharmacokinetics and Toxicology
2018-09-27, Small Molecule Formulation Development: Strategies for challenging APIs (jointly with AAPS-BADG)
2018-10-16, Drug-Drug Interactions: Preclinical Risk Assessment and Review of the new FDA Guidance
2018-11-01, cGMP Compliance for Quality Control and Laboratory Operations
2018-11-16, Protein therapeutics and biomarkers: Recent developments in characterization and quantification by hybrid LC-MS
2018-12-04, Challenges in Peptide Discovery & Drug Development: Biology, Chemistry, PK, Delivery, Regulatory and Beyond
©Pharmaceutical & BioScience Society, International; Last Modified: 7/20/2018; Visited: 225; Admin Logon
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