FDA Hosts Tour, Experts Discuss Risk and Rapid Methods at PDA Missouri Valley Chapter Event
The PDA Missouri Valley Chapter held its Fall Meeting in St. Louis, Missouri, on September 22, 2014. We began with a tour of FDA's Division of Pharmaceutical Analysis laboratory in St. Louis. This laboratory moved into new facilities within the past year and our group was the first to receive a full tour. Cindy Buhse, Division Director, hosted the tour of approximately 45 individuals from industry with an expert team of guides. The tour consisted of laboratories equipped for chromatography, mass spectroscopy, particle size determination and assessment, UV spectroscopy, dissolution, along with a variety of both research- and compliance-related analytical expertise. The tour was very informative and productive.
Eldon Henson of Mallinckrodt Pharmaceuticals provided an overview on the practical application of risk management to pharmaceutical manufacturing. He outlined the contents of PDA Technical Report #54 and provided a number of uses of quality risk management (QRM) approaches for both retrospective (e.g., quality and compliance issues that have already occurred, such as customer complaints and stability issues) and prospective (e.g., potential concerns, such as equipment changes, process changes, new regulations, etc.) issues. Henson noted that, though FDA is not currently asking for Quality Risk Management SOPs and general approaches in most facility inspections, it is wise to ensure that QRM be included, as appropriate, in procedures outlining key activities, such as investigations, technology transfer, and data trend analysis.
John Albright of BioMerieux provided a presentation on PDA Technical Report #33 regarding Rapid Microbiological Methods. He provided an overview of the development of the TR along with the rationale for many of its key elements. Albright stated that FDA has been very open to the approval of rapid microbiological methods, though key elements of cGMPs, such as assessment for the specific application, validation, training, etc., must be included in the conversion process.
Following Albright's presentation, a panel discussion was convened that included Albright, along with Erin Patton of Charles River Labs, Dave Mason of Lonza and Julie Sperry of Rapid Micro Biosystems. This panel addressed a significant number of questions from the 75 or so members attending. Key questions of interest revolved around the process of transitioning to rapid methods, FDA approval of rapid methods, and acceptance by global regulatory authorities.
The PDA Missouri Valley Chapter Learns About PDAs Quality Metrics Activities, Spring 2014
The Missouri Valley Chapter held its Spring Meeting at the Airport Hilton in Kansas City, Missouri on April 21. Three great speakers addressed about 70 attendees.
Warren Lopicka, from the Kansas City District Office of the U.S. FDA gave updates on the local FDA office organization and initiatives of the region.
Denyse Baker, Senior Advisor for Scientific and Regulatory Affairs with PDA, then gave an enlightening presentation on PDA’s Regulatory Affairs and Quality Advisory Board (RAQAB). We learned where this fits into the overall PDA structure, how RAQAB interacts with external agencies such as the FDA, EMA, ICH and others, and she reviewed the specific, recent process used to provide comments to the FDA regarding their quality metrics initiative.
Susan Schniepp, VP, Quality and Regulatory Affairs with Allergy Laboratories, then presented a detailed update on the background behind the quality metrics initiatives, the importance of these tools, areas of risk when trying to use quality metrics across a wide population of products/sites, and engaged the crowd with several real-life examples about how to implement quality metrics in a meaningful way.
The presentation concluded with a look at PDA’s future quality metrics activities. These include collecting feedback from members on specific definitions, updating PDA’s Points to Consider document, conducting a survey and holding a follow up conference to the 2013 PDA Pharmaceutical Quality Metrics Conference.
We look forward to our next meeting in the fall in St. Louis, Missouri! [Editor’s Note:
Updates on PDA’s quality metrics activities will be forthcoming in subsequent issues of the PDA Letter
. For an overview of PDA’s Points to Consider document and the 2013 PDA Pharmaceutical Quality Metrics Conference,
see the cover story of the February 2014 issue.]
PDA Missouri Valley Fall 2013 Event
The Missouri Valley Chapter had a successful Fall meeting in St. Louis, Missouri which focused on current trends in Environmental Monitoring. The chapter presented a recognition plaque to founding member and past-president, Eldon Henson, to thank him for his strong leadership and service as the chapters 2nd President. With many vendors and about 70 attendees, we viewed 2 very timely presentations.
The 1st was from Jeanne Moldenhauer. Jeanne shared her thoughts on the current issues facing microbiologists in Environmental Monitoring, with regards to regulations and expectations of regulatory inspectors. The 2nd presentation was from Joe Gecsey of Hach. Joe came to the meeting directly from his committee work as a long-standing member of the standards committee for ISO-14644. Joe shared valuable insights into the upcoming changes proposed for this cornerstone particulate classification and monitoring guidance.
Our next meeting will be in the Spring in Kansas City, Missouri, where we will continue our momentum as we grow our now-3-year-old chapter.
PDA Missouri Valley Spring 2013 Event
The Spring Meeting of the Missouri Valley Chapter of PDA was held on Monday, April 15, 2013, at the Overland Park Convention Center in Overland Park, KS. Approximately 70 attendees gathered to hear presentations from FDA and industry perspectives associated with the implementation of the “FDA Guidance on Process Validation. . .” Read more....
PDA Missouri Valley Fall 2012 Event
The Missouri Valley Chapter of PDA held its Fall Event on September 17, 2012. The dinner meeting was held at the Embassy Suites Conference Center in St. Charles, MO. The topic of the evening was “The Cost of Non-Compliance.”
Following a networking/social time and dinner, the Chapter was addressed by two excellent speakers; Mr. Jason Sapsin, JD, MPH, of Polsinelli Shughart, and Dr. Eric Good, of KV Pharmaceutical. . . Read more....
PDA Missouri Valley Spring 2012 Event
The Missouri Valley Chapter of PDA held its Spring Event on March 26, 2012. The dinner meeting was held at the Kansas City Airport Hilton Inn on the topic “Current Industry and Enforcement Trends.”
Following a networking/social time and dinner, the Chapter was addressed by two excellent speakers; Mr. Miguel Hernandez, Director, Compliance Branch at KAN-DO FDA, and Mr. Jim Polarine, Technical Services Manager, Steris Corperation. . Read more....
Second Event a Success for PDA Missouri Valley Chapter
On Monday, September 12th, the PDA Missouri Valley Chapter hosted its Fall meeting at the award winning Embassy Suites in St Charles, Missouri (St. Louis metro). The meeting topic was Supply Chain Trends.
Following a networking and vendor reception and buffet dinner, the meeting included talks from two great speakers representing industry and the U.S. FDA. Read more....
Missouri Valley Chapter Holds First Event
On Monday, April 25, the PDA Missouri Valley Chapter hosted its inaugural chapter meeting at the Kansas City Airport Hilton hotel. Following a networking/ vendor reception and buffet dinner, the meeting included talks from three distinguished speakers representing industry and the U.S. FDA. Read more....