Raps Pre-approved Webinar On responding To Fda 483" s From Globalcompliancepanel
Description:
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 companys business, and is often a major factor in the companys 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:
oHow to respond to an FDA Form 483
oUsing the preferred format
oThe timing of the response
oThe wording and tone of the response
oHow to put your company in the best light with FDA regarding the response
oWhat to include as attachments
oWhat to include in the response itself
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When:December 11, 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
oManager/Director QA
oManager/Director Regulatory Affairs
----------------------------------------------------------------------------------------------------------------
Duration: 60 minutes
-----------------------------------------------------------------------------------------------------------------
To enroll for this webinar, contact
[email protected]
Phone: 800-447-9407
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 companys business, and is often a major factor in the companys 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:
oHow to respond to an FDA Form 483
oUsing the preferred format
oThe timing of the response
oThe wording and tone of the response
oHow to put your company in the best light with FDA regarding the response
oWhat to include as attachments
oWhat 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
oManager/Director QA
oManager/Director Regulatory Affairs
----------------------------------------------------------------------------------------------------------------
Duration: 60 minutes
-----------------------------------------------------------------------------------------------------------------
To enroll for this webinar, contact
[email protected]
Phone: 800-447-9407
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