RAPS pre-approved webinar on "Responding to FDA 483's" from GlobalCompliancePanel
"Responding to FDA 483's" is the topic of a RAPS pre-approved webinar that GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize on December 11.
- Fresno, CA (1888PressRelease) December 11, 2012 - Timing and wording are at the core of a written response to a 483 by the FDA. Unfortunately, most companies do not realize this. They know that they have to give a response, but would unwittingly end up giving one that is low on the parameters most important to the FDA -timing and wording.
This response is crucial for a company's business, and is often a major factor in the company's continued relationship with the FDA.This webinar will give participants an idea of how to word and time their response to a 483. This learning will give them an understanding of how to put their best position before the FDA.
This webinar will offer examples of well written and badly written 483 responses. Participants will learn which the best response to an FDA 483 is, from this session. It will cover the following areas:
o How to respond to an FDA Form 483
o Using the preferred format
o The timing of the response
o The wording and tone of the response
o How to put your company in the best light with FDA regarding the response
o What to include as attachments
o What to include in the response itself
When:December 11, 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 Manager/Director QA
o Manager/Director Regulatory Affairs
Duration: 60 minutes
To enroll for this webinar, contact
webinars ( @ ) globalcompliancepanel dot com
Phone: 800-447-9407
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