The Compliance Authority Synopses

Maturity of Hackers, IT Managers and End Users – By Rick Shaw, CEO/President, Awareity

As stated in a previous article, maturity is a psychological term used to indicate that an individual responds to the circumstances or environment in an appropriate and adaptive manner. The individual’s response is generally learned rather than instinctual and this maturity does not depend on one’s age. An individual’s maturity encompasses being aware of the correct time and place to behave and knowing when and how to respond.

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Training in a cGMP Environment
Presenter: Cynthia SM Kura, PhD – Medical Director, Dachshund Rescue of Bucks County & NJ

Abstract:
The most cited violation by FDA inspectors, the failure to train personnel. Learn why this process is such an important component in the FDA compliance wheel and the important components of a successful program.
Topics included are:

• Training and its place in the compliance arena
• Popular training methods currently in use and their downfalls
• Training and the tie-in to CAPA
• Who needs to be trained and when
• How to develop a good training program
• The future in compliance training

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