•   The three speakers adeptly picked apart and exposed weaknesses in the new 2004 FDA Guidance "Sterile Drug Products Produced by Aseptic Processing." They very capably fielded people's questions including my own.

•   I didn't know that Jim Agalloco is a local member and volunteer on the PDA Metro chapter. I look forward to chatting with him at future meetings.

•   Dr. Sutton provided us a great overview of Rapid Microbiological Methods, some of which could be considered Process Analytical Technology (PAT). 

•   Dr. Scott Sutton gave us a microbiologist's perspective on the pluses and minuses of a number of rapid on-line and off-line microbiological methods, including new identification systems.

•   I enjoyed the "super sleuth" bacterial contamination investigations Dr. Ken Muhvich described. He shed considerable light on various preventive and corrective actions that pharmaceutical plants with microbial contamination should take.

•   It was terrific hearing Dr. Jim Akers speak on aseptic processing sterility assurance and risk mitigation technologies. He highlighted a number of subtle, and unaccounted for component exposures during filling operations, e.g., the time stoppers spend in the hopper, time periods of line stoppage, and the fact that more interventions occur when auditors are not present or during media fills.

•   It's incredible what widely published and informative speakers PDA Metro always attracts. What a great way for me to keep up with cutting edge methods and teachings as well as satisfy my ASQ recertification requirements.

•   The organization of these PDA Metro dinner meetings is perfect. I can chat with peers  and vendors over drinks and hors d'oevres, enjoy an excellent buffet dinner, and hear and learn from some of the true experts in Sterility Assurance, Microbiology, and Pharmaceutical GMPs.