I just finished attending Reglera’s 7th Reproductive Compliance Conference in Arlington, VA. Two days of going over FDA regulations, current regulatory trends and case studies; and I can honestly say I thoroughly enjoyed it.
Day 1: Living Documents
Day 1 began with a welcome and introduction from Reglera president, Clay Anselmo. New to this year’s conference was the use of Bluetooth clickers for audience quizzes. Clay utilized them right away to get an understanding of the attendees’ knowledge of the FDA regulations.
We then heard from the VP of regulatory affairs, Marty Wells. He spoke about knowing who our regulators are and recent regulatory history. Clay then returned to the podium to give an overview of the applicable part of FDA 1271 requirements. This regulation goes over donor eligibility and good practices concerning human tissue based products.
After a morning break, the tissue services manager, Amy Johnson, went into great detail to help clarify the donor requirements as listed in regulation 1271. This was followed by tissue specialist, Cindy Blinci, thoroughly describing the donor testing requirements and how we can better implement systems regarding testing.
After we all got to have some lunch Amy continued on current trends in the reproductive industry and what we should be on the look out for as we engage with other facilities. This was particularly helpful as we heard from several clinics give constructive feedback for both sperm and egg banks. Cindy then got back up and gave a presentation about the importance of establishing and maintaining procedures. The big takeaway here is that, we need to view our procedures as living documents; always needing review, and updates when necessary.
At the end of the first day, Reglera was kind enough to host a reception for us. This was a lot of fun, and a great opportunity to connect with other professionals in the reproductive field.
Day 2: Applied Learning
Day 2 started up with Cindy speaking on the use of and regulations regarding electronic systems. This was followed by the quality assurance director, Rich Weiskopf, making his first trip to the podium to discuss how we as tissue manufacturers must qualify our manufacturing partners before utilizing their services; namely in regards to testing facilities.
Following the morning break, Amy got the audience to participate in case studies regarding gamete and embryo donation. We all broke into groups going over 15 different case studies to interpret the regulation and see how it applied to each case study. Rich then gave an interactive presentation about why and how to write an FDA 483 form response. The attendees were able to work in groups again to determine the best corrective and systemic action plans while formulating the 483 response.
At the end of day 2 Clay had the audience take another quiz with the Bluetooth clickers to assess what we had learned and to see what areas of our knowledge still needed improvement. This was the highlight of the conference for me, as it was encouragingly clear how much we as an audience had learned over the two days.
Overall the conference was very informative, sharpening and enjoyable. It not only provided an opportunity to keep us up to date with federal standards, but also brought us to strive for better practice in the future. I look forward to attending again next year.
