When: |
25 Aug through 25 Aug 2020 | |
Where: |
Online Event | United States | |
Website URL: |
https://www.complianceonline.com/prepare-fda-cgmp-audit-cfr-webinar-training-706513-prdw?channel=brownwalker | |
Sponsoring organization: |
Compliance Online | |
Categories: |
Medicine & Health - Other |
Keywords:
Event description:
Recent US FDA Inspections ("audits") indicate the "c" in CGMP is a moving target – with expectations growing upward! In this webinar, learn how to use the FDA's inspection flow charts and questions, past inspections, and key elements of the CGMPs to prepare for an FDA GMP Compliance Inspection. Recognize that past results are not an accurate of future inspection results. You will learn how to incorporate industry findings into your gap analysis and remediation plan.
There is an on-going major shift in the emphasis of U.S. FDA CGMP compliance inspections (audits). These changes in focus have a major impact on individual compliance objectives, efforts and measurements of success. All this affects the Agency's approach to audits and their expectations for companies. They also use GMP compliance audits to drive companies to do much of their work for them.
Failure to anticipate, find and correct compliance problems before an FDA site inspection can result in unnecessary 483 Observati...
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Posting date:
09 August 2020 | 177 views
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