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Phone: 800-447-9407

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

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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

Compliance Manager



Facility Manager Validation Manager Regulatory Manager


Design Team/Architects


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Click here to register for this webinar It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator GlobalCompliancePanel About GlobalCompliancePanel GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model for online compliance training by creating a single window of learning opportunities for compliance professionals & providing a forum for expert speakers/panelists to render their services through simplified online training delivery mechanisms. Our commitment is give compliance regulatory training, showcasing of best industry practices & quality enrichment training sessions in a most cost effective manner. Compliance professionals can benefit from a wide range of training sessions, giving a diverse choice of events & all sessions being either Live or recorded stream or in the form of audio CDs. GlobalCompliancePanel portal ensures a secure & cost effective online environment and also support your E-learning and development on/through our website. Keep track of all webinars arranged for your industry through notifications & event

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Pharmaceutical and Biologics Facility Design - Webinar By GlobalCompliancePanel  

This course explores some of the best practices of pharmaceutical facility design with an emphasis on the regulatory aspect. FDA and other r...

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