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Good Documentation Lies At The Heart Of Gxp Environments

By Author: Adam Fleming
Total Articles: 43

Good Documentation Practice (GDP) constitutes the backbone of any GxP environment. Not only is GDP a sound business practice; it is also an FDA requirement. This being the case, it is absolutely essential for FDA-regulated organizations to get their GDP right. An organization that does not get its GDP right risks facing a number of consequences.
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.

A learning session to help get an idea of GDP
In order to make those in regulatory professions understand the essence of GDP for GxP environments, Compliance4All, a highly reputable provider of professional trainings for the regulated industries, is organizing a very valuable webinar. Details of this webinar can be had from http://www.compliance4all.com/control/w_product/~product_id=500978LIVE.
The speaker at this webinar, John Godshalk, will make participants understand what needs to be documented, and the rationale for it, such as what companies need to know to comply with regulations regarding documentation, what Good Documentation Practice (GDP) is, what needs to be documented, why it is documented, and FDA expectations for documentation.

Learning to understand the FDA’s requirements for GDP
This learning session will explain what the GxP regulations and guidances say about Good Documentation Practice and offer examples of both good and poor documentation. It will offer exercises of both good and poor practices, which will help participants 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, the relevant regulations that exist for documentation, and the related guidances.

John will cover the following areas at this webinar:
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

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