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10 Aug 2020Ended

Good Documentation Practices - What Helps Make Your Controlled Documents Compliant

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upto 100
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Based on previous editions

Editions

10 Aug 2020
+1 more editions

Frequency

Quarterly
Next edition likely in Nov 2020
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Officially there is no requirements as per the FDA and other regulatory bodies for “good documentation practices”, however, it is a “current” .. Read more industry practice and if often reviewed and cited by auditors during audits. All legal and controlled documents are subject to the retention of information which should include the sign and dating of such data by the person responsible. Good documentation practices are expected to assure that all recorded data is accurate, legible and traceable. We all know that the FDA strongly believes “if it wasn’t documented, it didn’t happen”. FDA also wants to see how you document results. It’s also been observed that the lack of good GDP is consistently cited in FDA 483 observations. The training departments need to make GDP an integral part of every employee training.

Speaker
Kenneth Christie

Kenneth Christie

Quality Assurance and Validation Management
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