Equipment qualification protocols and validation

For equipment manufacturers, validation and proper documentation can be a barrier to entry in the pharmaceutical sector. Manufacturer representatives from packaging equipment firms have often told me how their company was interested in the pharmaceutical market, enthused about a new machine's potential to succeed in this market. Then, a few months later, that enthusiasm wanes.

It's easy to become overwhelmed by validation's challenges. Experienced guidance is the key. Next March in Philadelphia, Healthcare Packaging will host the Pharmaceutical Packaging Forum. One of the speakers is Edward M. Sybert, Heritage Biotechnology Consulting. Sybert's afternoon program, "Developing Installation and Operational Qualification Documents for your Packaging Equipment," will educate packagers about developing installation and operational qualification documents for packaging equipment.

This informative presentation will include an overview of FDA expectations, as illustrated by real world examples. Sybert brings to the one-day Forum more than 35 years of experience in biotechnology and engineering and will offer insights about equipment qualification protocols and validation for packagers.

By Jim Chrzan, Publisher