Biologics Facility Design & Pharmaceutical Regulatory Aspects - 2017
- Total time
Biologics Facility Design & Pharmaceutical Regulatory Aspects - 2017
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Description
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.
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 …
Frequently asked questions
There are no frequently asked questions yet. If you have any more questions or need help, contact our customer service.
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.
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
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. 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.
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com
Full Details & Registration Link: http://www.compliance4all.com/control/w_product/~product_id=501112LIVE?channel=mailer&camp=Webinar&AdGroup=springest_Apr_2017_SEO
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Do you have experience with this webinar? Submit your review and help other people make the right choice. As a thank you for your effort we will donate $1.- to Stichting Edukans.There are no frequently asked questions yet. If you have any more questions or need help, contact our customer service.