- FDA cGMP QSR GMP Online Training - respected cGMP online training classes offered by SkillsPlus International Inc.
According to GMP Trends Inc., "an FDA 483 is a form used by an FDA investigator following an inspection of your plant. It lists deficiencies in your quality system and potential non-compliance issues with GMP's. These observations are based on the investigators interpretation of the GMP regulations as they apply to your specific situation. During the investigator's closing meeting with management, you may be given a Form 483." You can learn more about the FDA's thinking on 483s by reading this section from one of their manuals, FDA Investigations Manual - Reports of Observations.
These 483s can do several things for you. They'll:
- Get you more familiar with what a 483 is all about
- Give you the willies so you'll never want to earn your own 483s
- Provide examples that you can incorporate into your GMP training efforts
Surviving An FDA Inspection - GMP Training - Taught by SkillsPlus International Inc.
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2 comments:
I totally agree - 483s are serious. With the recent increase in warning letters, 483s, and consent decrees, companies would be wise to respond as quickly, comprehensively, and logically as possible.
check out a new listing of FDA 483s:
http://www.fdazilla.com/fda/compliance/483/
it is a fully-searchable list of FDA 483s over the last 10 years.
FDA GMP QSR cGMP Online Training: FDA cGMP QSR GMP Online Training - popular online training courses by SkillsPlus International Inc. #FDA #cGMP #GMP #QSR #training
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