GlobalCompliancePanel to organize webinar on "Good Documentation Practice for GxP Environments"
GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize a webinar on the topic; "Good Documentation Practice for GxP Environments"on January 15.John R. Godshalk, Senior Consultant at Biologics Consulting Group will be the Speaker at this session.
- Fresno, CA (1888PressRelease) January 15, 2013 - The scope of this webinar is to discuss Good Documentation Practices (GDP) for GxP environments.
Today's regulatory requirements are stricter than ever before. In this environment of very rigid regulatory environment; individuals and companies have to comprehend and adhere to good documentation that meets FDA regulatory requirements.
This webinar will make participants understand what needs to be documented, and the rationale for it. This will enable them to come up with GDP that meets FDA requirements.
This session will give participants an idea of GDP for GxP environments. They will be able to understand what the FDA looks for in documentation, relevant regulations that exist for documentation, as well as the related guidances.
This session covers the following areas:
o FDA 101: Who is the FDA, regulations, guidances, documentation and me
o Why document?
o What needs to be documented?
o What documentation does FDA look for during an inspection?
o What do the GMP, GCP, and GLP regulations and guidance's say about documentation?
o Examples and exercises for good documentation
o Summary/Q&A
When:January 15, 10:00 AM PDT | 01:00 PM EDT
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.
For whom:
The webinar will benefit
o GxP personnel involved with GxP Documentation
o R&D
o Production
o Quality
o Regulatory
Duration: 60 minutes
To enroll for this webinar, contact
webinars ( @ ) globalcompliancepanel dot com
Phone: 800-447-9407
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