Pharmaceutical and Biologics Facility Design: FDA and Regulatory Aspects


  Duration: 60 Minutes  

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John R. Godshalk   Product Id : 500884
  Instructor : John R. Godshalk

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Overview:

This course explores some of the best practices of pharmaceutical facility design with an emphasis on regulatory aspects. FDA and other global regulatory body requirements are discussed and the reasoning behind them.

Examples of floorplans and flows (people, product, etc.) are examined and discussed. Specifics for fixtures, finishes, HVAC and other design aspects of cleanrooms are discussed in terms of current practices and GMP requirements. Examples of design choices for pressurization, flows and HVAC zones are given along with their possible application. Design specifications for both open and closed systems are discussed along with current standards.

Why should you Attend: The attendee will learn what is important in facility design from the FDA and regulatory standpoint. The attendee will understand what FDA looks for during a facility inspection. The attendee will be able to minimize possible design errors which are difficult and expensive to fix post-build. The attendee will understand what FDA looks for in reviewing the facility design and the flow patterns.

Areas Covered in the Session:

  • Best design practices for Pharma facilities
  • Best design practices for biologics facilities
  • Regulatory compliance for Pharma and biologics facilities design
  • Flow patterns and cross contamination controls
  • Design criteria for fixtures and finishes
  • Examples of good design
  • General specifications for different classification zones
  • Examples of design specs for cleanrooms

Who Will Benefit:
  • Compliance Manager
  • Facility Manager
  • Validation Manager
  • Regulatory Manager
  • Design Team/Architects


Speaker Profile
John R. Godshalk currently works for the Biologics Consulting Group as a Senior Consultant. He served as a Senior Review Biochemical Engineer and Lead cGMP inspector in the Division of Manufacturing and Product Quality at CBER, FDA. He contributed to formulation of FDA policy. He has audited/inspected hundreds of pharma and biotech companies and reviewed processes and PV at these plants. John has provided advice to industry on regulatory strategies, pharmaceutical product facility design, best practices, and validation approaches that meet FDA licensing requirements. John received his B.S. in chemical engineering from N.C. State University and his M.S.E. in biochemical engineering from Johns Hopkins University.




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