When: |
31 May through 31 May 2022 | |
Where: |
Online Event | United States | |
Website URL: |
https://www.complianceonline.com/major-cgmp-issues-in-2022-webinar-training-702185-prdw?channel=Brownwalker | |
Sponsoring organization: |
Compliance Online | |
Categories: |
Medicine & Health - Pharmaceutical / Medicinal |
Keywords:
Event description:
This webinar will evaluate the chief areas of FDA CGMP and EU compliance inspections to see actual and anticipated changes in emphasis, and how to better prepare with a company's proactive internal inspection / audit program.
Why Should You Attend:
A review of recent US FDA Inspectional Observations / FDA Form 483 Observations, as well as FDA statements and actions, indicate the major areas of regulatory concern. The past is no indicator of present or future concerns. The Agency uses publicized high-profile cases to drive compliance in the regulated industries. Certain CGMP areas, e.g., CAPA, are receiving increased scrutiny. "Risk-based" (patient risk) is another. Failure to correct problems leads to Warning Letters or more severe regulatory actions. Requirement for "better science" must be evident in compliance. "Business as usual" is never acceptable, but do some of a company’s documents reflect that outdated thinking. Also changes from the EU, MDD to MDR, ISO 13485:2016 .....
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Posting date:
23 April 2022 | 200 views
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