GlobalCompliancePanel to organize RAPS pre-approved webinar on "Good Deviation Practice: What you need to know"

"Good Deviation Practice: What you need to know" is the topic of a RAPS pre-approved webinar that GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize onNovember 27.

Wilmington, DE (prHWY.com) September 21, 2012 - Description:
This session covers deviation and CAPA process, and details best practices for both.
Having the right deviation and CAPA process in place in a Quality System is essential from a regulatory perspective. A robust and resilient deviation and CAPA process and thorough investigation helps avoid pitfalls and minimize regulatory scrutiny. This webinar will give participants an understanding of how to bring these about.
It will explore and evaluate the deviation process and offers examples of the best way to handle deviations and consequent CAPA's. This session will also offer reasons for which a strong deviation process has to be put in place. Examples are given of these.
This session covers the following areas:
o Explores typical deviation and CAPA processes within the Quality System
o Explores best practices for the deviation and CAPA processes
o Explores best practices for documentation
o Tips on how to avoid possible pitfalls with deviations
o Tips on minimizing regulatory scrutiny with deviations
o Examples of good deviation write-ups, investigations and CAPA's
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When:November 27, 10:00 AM PDT | 01:00 PM EDT
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By whom: John R. Godshalk, MSE, MBA, is a Senior Consultant at the Biologics Consulting Group.

John served as a Senior Review Biochemical Engineer and Lead cGMP inspector in the Divisionof Manufacturing and Product Quality at the Center for Biologics Evaluation and Research(CBER), Food and Drug Administration (FDA) for over three. Prior to joining FDA he worked asa management consultant after obtaining his MBA.

John has experience with products that include drugs,drug/device combination products, viral and bacterial vaccines, recombinant therapeutic andfractionation products, in vitro diagnostic test kits, and 510K medical devices. His inspectionexperience includes leading inspections of active pharmaceutical ingredient manufacturers,aseptic filling and finishing facilities, and contract manufacturers.

John has provided advice to industry on regulatory strategies, pharmaceutical product facility design, best practices, and validation approaches that meet FDA licensing requirements. He currently works to assist clients inthe areas of cGMP, regulatoryaffairs and management consulting.
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For whom:
The webinar will benefit
o Compliance Manager
o Process Engineer
o Production Manager
o Regulatory Manager
o Quality Manager
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Duration: 60 minutes
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To enroll for this webinar, contact
webinars@globalcompliancepanel.com
Phone: 800-447-9407

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Tag Words: capa processes, good deviation practice, online training

Categories: Health

Press Release Contact
GlobalCompliancePanel

Phone: 800-447-9407
Fax: 302-288-6884

webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

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