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Workshop

Good Manufacturing Practices (GMPs) from R&D through Commercialization: Fundamentals, Regulatory Trends and Best Practices


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: (7)Alcami; BioDuro; BioKey, Inc.; MabPlex; MilliporeSigma; Nitto Avecia Pharma Services, Inc.; PerkinElmer
Registration: http://www.PBSS.org
Registration deadline:10/23/2017  (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

About the Speakers

Marion Weinreb has over 40 years of quality systems experience in the medical device and pharmaceutical industries. Marion has worked at major companies like Altana, Inc., Forest Laboratories, Johnson & Johnson, Syntex and Roche Bioscience. She focuses on GMP and/or QSR auditing in both non-sterile and sterile drug, device and combination systems, Pre-Approval Inspection preparation, PAI mock audits, quality systems development and continuous improvement, cGXP training, GMP document development, and problem resolution for compliance issues. She has worked for small and large companies and has a successful track record for dealing with complex compliance issues in development and commercial settings. Marion holds a BA in Biology and an MS in Pharmaceutical Marketing.  She is currently President of MWA Consulting, Inc. where provides GXP consulting expertise 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
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