| Description |
Structured, defined and tested CGMP systems are the start in successfully passing the "real thing". Increasingly such systems are to be risk-based, as stated by the US FDA and the EU. So, where does a company look to ensure their compliance is structured and prioritized by risk? How to create and blend the Risk Management File findings into the company's internal and external audit plans? How is it established, maintained, formally updated, and documented? Learn from others mistakes - current FDA 483 observations. The receptionist - an auditor's first company contact. Strategic perception. Arrangements for and facilitation of the outside audit. Training personnel on how to be "audited". Close outs "musts". Where and how to draw the "line in the sand". Responses - how, what, frequency. Avoiding Warning Letters.
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