RAPS Approved Webinar on
Pharmaceutical and Biologics Facility Design: FDA and Regulatory Aspects Date: Tuesday, November 6, 2012
Time: 10:00 AM PDT | 01:00 PM EDT
Course "Pharmaceutical and Biologics Facility Design: FDA and Regulatory Aspects" has been preapproved by RAPS as eligible for up to 1.00 credits towards a participant's RAC recertification upon full completion.
Duration: 60 Minutes Instructor: John R. Godshalk Location: Online Price : $245.00 (for one participant)
John R. Godshalk Senior Consultant, Biologics Consulting Group, LLC
John currently works for the Biologics Consulting Group as a Senior Consultant. John 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. ...more
Overview: This course explores some of the best practices of pharmaceutical facility design with an emphasis on the regulatory aspect. FDA and other regulatory body requirements are discussed and the reasoning behind them. Examples of floorplans and flows (people, equipment, 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.
Areas Covered in the Session: l l l
l l l l
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: l
Facility Manager Validation Manager Regulatory Manager
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This course explores some of the best practices of pharmaceutical facility design with an emphasis on the regulatory aspect. FDA and other r...