Biologics Facility Design & Pharmaceutical Regulatory Aspects - 2017
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Website http://www.compliance4all.com/control/w_product/~product_id=501112LIVE?channel=mailer&camp=Webinar&A |
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Category food and drug administration, fda drugs, drug administration, fda regulations, cgmp training, FDA Compliance Training, FDA compliance seminar, biologic, biologic drugs, biologics manufacturing, pharmaceutical companies
Deadline: April 03, 2017 | Date: April 04, 2017
Venue/Country: Fremont, U.S.A
Updated: 2017-02-24 18:44:17 (GMT+9)
Call For Papers - CFP
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 facilitiesBest design practices for biologics facilitiesRegulatory compliance for Pharma and biologics facilities designFlow patterns and cross contamination controlsWho Will Benefit:Compliance ManagerFacility ManagerValidation ManagerRegulatory ManagerDesign Team/ArchitectsSpeaker 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: +1-800-447-9407Email: supportcompliance4All.com
Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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