PDA Letter Article

Missouri Valley Chapter Dinner Taps Inspections/Annex 1

by Patrick Kane, Veltek Associates, Inc. and chapter board member

The PDA Missouri Valley Chapter held its fall dinner meeting at the Boulevard Brewing Co. in Kansas City, Mo. With an exceptional turnout and top-of-mind topics, PDA Missouri Valley was able to truly live up to the motto, Connecting People, Science and Regulation. More than 90 people signed up for this event.

Paula Pecos (ValSource) discussed Annex 1 and updates to Environmental Monitoring and Sampling in front of a room of attendeesPaula Pecos ValSource, Inc., discussed Annex 1 and updates to environmental monitoring and sampling. She immediately addressed questions revolving around the new Annex 1 release. With interactive discussion and dialogue, the timing, topic and questions had an immediate impact on the audience. Feedback from attendees pointed to great interest and direct impact on current needs and concerns.

Heath Coates discussed re-inspection readiness for Aseptic manufacturing facilities to a room of attendeesHeath Coates Dark Horse Consulting (formerly with the U.S. FDA), discussed reinspection readiness for aseptic manufacturing facilities. An FDA inspector in the audience helped explain how to properly prepare for any health authority inspection during the interactive presentation. His expertise and experience simplified the questions of what to expect, how to approach each visit and what investigators are trying to help companies understand. Having this insight and transparent reasoning when inspected by the FDA put a new perspective on investigations.

The surveys showed strong approval and appreciation for both topics.