January 2014

For Pharmaceutical Companies

6 Ways to Leverage Risk-Based Monitoring & CAPA

by Cindy Fazzi, MasterControl Inc.

While most companies have risk management and clinical CAPA processes, they’re not leveraging CAPA to strengthen risk management and vice versa. If your company is a sponsor or a CRO, how effective are your risk management and clinical CAPA processes? Are you using them to supplement each other?

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How to Confuse Your Trainees in 10 Easy Steps!

by Jill Drummond, Blood Systems

On-the-job training is usually conducted one-on-one or in small groups so it can be challenging to confuse trainees; but fear not — when employees start a new job, they are usually a little nervous or apprehensive. They want to make a good impression and they want to be successful in learning their new tasks. This is when they are most vulnerable and they are easy pickings for total confusion. Follow these simple steps and you will have your new hires running for the hills and totally flabbergasted and ineffective in their jobs.

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A Risk-Based Approach to Validation

by Peter Knauer, MasterControl Inc.

FDA classically has defined the requirements for validation under 21 CFR 820 and 210/211 regulations as a comprehensive testing process where all systems are given thorough examination and tested under equal weight, complete with an exhaustive evaluation process. This article describes a new definition of validation that has emerged. What is this new definition and how does it affect you?

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