Janera Harris, Cytonet | May 27, 2015
In March, I spent a week at the 2015 PDA Annual Meeting in Las Vegas not only learning more about the industry but also interacting and networking with other professionals in the areas of manufacturing and quality.
In March, I spent a week at the 2015 PDA Annual Meeting in Las Vegas not only learning more about the industry but also interacting and networking with other professionals in the areas of manufacturing and quality. This was my first time attending a PDA conference since joining last December. My interest in the topics covered at this meeting served as a driving force in my decision to join.
The Sunday before the meeting, I went down to the registration area following my arrival, picked up my packet and began meeting some very interesting and entertaining PDA board members during the Meet and Greet Reception. While talking with them, I learned about all the things that PDA does, how it’s strongly volunteer-driven and has a deep-seated role in the regulations issued from the different governing bodies. The next morning, I attended the new member breakfast where I met other new PDA members and learned even more about the various volunteer opportunities available within PDA.
One of the sessions I looked forward to the most was the plenary session “Importance of Science & Technology to Building a Quality Culture.” As Director of Quality at a small cell therapy company where everyone wears a lot of different hats, it is important to learn different ways to foster a quality culture. Another session I found beneficial explored new processes and challenges facing cell therapy products. It was interesting to hear about the different hurdles other cell therapy companies face with getting their product to market.
I also attended a couple of the breakfast sessions. At the quality metrics meeting, I learned about the quality metrics guidelines that the U.S. FDA plans to release at the end of 2015 and how that will impact the industry. At this same meeting, I also learned that the European Union now plans to focus on quality metrics during audits they perform. One of the other breakfast sessions I attended provided an update on the aging facilities task force. To hear about the different problems that companies experience when updating their facilities was eye opening.
One of the interest group sessions I attended covered management of outsourced operations. My company, Cytonet, is a contract manufacturer, but we also outsource different operations to other companies. Quality agreements are becoming more and more important in the relationship between the contract giver and contract acceptor, and, in many instances, this is where the communication is outlined between the two. Participants in this meeting lively discussed this topic and shared viewpoints from both those who work for a contract manufacturer and those who receive the services of a contract manufacturer.
Overall, my experience at the PDA conference was very positive. I learned a lot of valuable information and appreciated the opportunity to discuss with other professionals the various problems we all face. My biggest takeaway was that no matter what size company you work for—small, midsize or large—we all face the same problems and can all learn by sharing our experiences with each other.
About the Author
Janera Harris is the Director of Quality at Cytonet, a liver cell therapy company, located in Durham, N.C. She has been with Cytonet for eight years in the areas of manufacturing and quality.