February 2014

For Pharmaceutical Companies

"3 Loops in 1" as Reflected in FDA Warning Letters

by Cindy Fazzi, MasterControl Inc.

Anyone who keeps an eye on the FDA’s website for enforcement actions and warning letters knows that violations pertaining to corrective action and preventive action (CAPA) are among the most common issues cited by the agency (1).

Many of the citations could have been avoided, or at least mitigated, with the help of a closed-loop or “three loops in one” CAPA process. What is it and why is it critical?

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Collaboration is More Than Just a Buzzword

by Marty Jackson, MasterControl Inc.

Each year, there seems to be a buzzword that pervades the business community. This year, I recall hearing the word “collaboration” more than ever. For most organizations, the word is synonymous with “participate.”

Indeed Merriam Webster offers this definition: “to work jointly with others or together especially in an intellectual endeavor.”

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Responding to FDA 483s: Do’s, Don’ts, and When to Call in a Remediation Partner

by Lisa Weeks, MasterControl Inc.

Operating under the oversight of the FDA and other global regulatory agencies creates a climate of transparency for regulated companies; any misstep can result in severe consequences such as product seizures, recalls, or company closure. Therefore, the way you respond to FDA Form-483 observations, warning letters, and other critical events is vital to your company's survival. Having a sound quality management system in place is critical, but when remedial action is necessary, time is of the essence. After all, you have only 15 working days from the receipt of the 483 to respond!

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