25th April 2023 Content supplied by: Charles River Microbial Solutions
That’s a Wrap: The 2023 QC Micro Summit
The 2023 QC Micro Summit, the 4th annual industry thought leadership event, is an opportune time for quality control microbiologists and industry experts from all backgrounds and organizations including, AstraZeneca, Baxter, Thermo Fisher, the National Institute of Standards and Technology (NIST) & Steris to step out of the lab for a few days, connect with their peers and share their stockpiles of knowledge. The fact that this event is held in sunny Charleston, SC, every year is a plus for attendees.
Another plus is the aspect of keeping the event small. The focus of one-on-one perspectives is the priceless part of the week and is what delivers the real value in participating. It was evident that no one felt like just another number at a tradeshow.Canine cleanroom suits and regulatory updates
Yes, you read that correctly. Attendees had a comical conversation about the all-too-real Canine Cleanroom Suit, which only leads one to wonder why they had to invent such a thing in the first place.
The Summit kicked off with a keen focus on bacterial endotoxin testing (BET). As we all know, the industry is at an exciting crossroads with the onset of recombinant, cellular, and biochemical technologies. It is more important than ever to also be looking to the evolution of equivalence standards with these new methods of detection. Karen McCullough of MMI Associates, an expert in quality control and, more specifically, BET, honed in on the necessity of updates in equivalence standards due to a general lack of standards specifically for these new test methods.
Dr. Michael Miller from Rapid Microbiology Consultants reviewed case studies on contamination control strategies for non-sterile manufacturing facilities that have arisen in the last decade and led to US Food and Drug Administration warning letters, 483’s and even an indictment in 2022 with the former CEO of PharmaTech. These cases focused heavily on instances in which Burkholderia cepacia complex was detected and had affected both consumers and patients.
Returning speakers from our 2022 event included the renowned Dr. James Cooper, founder of the Endosafe® brand of BET, who gave us a history lesson on his journey toward becoming a better microbiologist. Ziva Abraham, Founder of Microrite, shared her knowledge on mold contamination control strategies for cell and gene therapy cleanrooms. Also back was Vanessa Vasadi Figueroa, owner of VVF Science, who offered a “best practices” lesson in how to implement environmental monitoring software.
Along with these seasoned veterans, we were excited to welcome several new speakers who brought stimulating and insightful perspectives, such as Scott Jackson, Group Lead for Microbiology at NIST. He gave us an overview on current happenings at the government agency and the group’s thoughts on standards for microbiome measurements. Also joining us for the first time was Abby Roth, owner of Pure Microbiology, who presented key takeaways from the USP 797 Environmental Monitoring updates. She emphasized the need for internal training and building confidence in your lab personnel.
Attendees took advantage of a networking opportunity with Jim Massey, Chief Sustainability Officer at Zai Lab. He gave a great presentation on taking action and achieving sustainability in your organization. Everyone went home with a signed copy of his new book, “Trust in Action: The Leader’s Guide to Act Right Now,” as well as a new perspective on caring for what you do in your career.
With days full of panel discussions, information gathering, and product demonstrations, we made sure we built in some play time, too. Attendees were able to “network” with horseshoe crabs and stingrays at the South Carolina Aquarium’s touch tank.
We’re actively planning for the QC Summit in 2024. If you’d like to be added to our Save the Date invitation next year, shoot us your message using the green "Request Information" button below.
Date Published: 25th April 2023
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