November 2013

For Pharmaceutical Companies

6 Ways to Leverage Risk-Based Monitoring & Clinical 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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SOP Training is Now “On-Line” But Are We Any More Compliant?

by Vivian Bringslimark, HPIS Consulting, Inc.

According to an excerpt from the PDA’s Pharmaceutical Sci-Tech Discussion Group, there is “almost a 100% correlation between the percentage of read and understood SOPs and the number of compliance issues the company has.” Has efficiency become the new metric for training and compliance? Using technology to read SOPs doesn’t guarantee learning transfer.

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Grid Analysis for Simplified Supplier Selection

by Jennifer Stepniowski, Pro QC International

The selection of a new supplier can be an arduous process, and the importance of the decision is inarguable. Changing suppliers when continuous improvement recommendations fail to succeed most surely will result in high switching costs. Ultimately, the decision is worth careful evaluation, which makes a grid analysis a useful and easy tool to use.

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