The PDA Letter reached out to the new Regulatory Affairs and Quality Advisory Board (RAQAB) Chair Jeff Broadfoot, Director, Corporate Quality Compliance, Emergent BioSystems, and Vice-Chair Jackie Veivia-Panter, Consultant, and asked them a few questions about their plans for the RAQAB.

PDA Letter: What are some of your overarching goals as the new co-chairs of the RAQAB?

Jeff and Jackie: First, we want to be proactive in identifying significant emerging regulatory and compliance issues, and then provide advice to the Board of Directors so that PDA can mobilize resources to support PDA’s membership.

We also plan to develop a robust succession plan for RAQAB in order to ensure we have the global and diverse knowledge available to meet the needs of ever-expanding and changing regulations.

And we will engage with PDA members about RAQAB’s role by communicating the benefits of RAQAB and understanding the needs of PDA members. This includes collaborating with PDA chapters, providing articles for the PDA Letter and PDA Journal, and reaching out to interest group members.

PDA Letter: What experience do you bring to RAQAB? Both from industry as well as from being members of RAQAB?

Jeff: I’ve been in QA/QC in the pharma industry for almost 25 years in facilities manufacturing everything from medicated ointments and creams to tablets and capsules to biologics and parenterals. I’ve been in management for about 15 years. I’ve covered a lot of ground in that time and understand the complexity of making pharmaceuticals, as well as the day-to-day challenges of running a manufacturing site. I’ve been a member of RAQAB since 2009 as the Canada Regional Rep. I spent the last three years as Vice-Chair before becoming Chair in July of this year. That experience has given me a great appreciation for the role that industry can and does play in shaping both the regulatory environment and the concept of quality.

Jackie: I have over 25 years of experience in pharmaceutical quality. My experience is in R&D and Operations in many aspects of the pharmaceutical quality system. Much of my time has been spent improving quality systems and ensuring regulatory requirements are met. This will be the first year as a co-chair on the RAQAB and I am really looking forward to it! I have learned so much from all the members and past chairs. It will be a great opportunity to continue the great work established and ensure improvement to meet the needs of the industry.

PDA Letter: What topics will RAQAB address in 2017?

Jeff and Jackie: RAQAB will continue to work on hot topics such as data integrity, post-approval changes, and quality culture metrics.

PDA Letter: What are you most looking forward to as co-chair?

Jackie: I have enjoyed being a member of the RAQAB. The breadth of knowledge within the RAQAB is incredible and has really challenged me to grow and learn. I am looking forward to continuing this and helping the RAQAB and its members succeed in their mission.

Jeff: One of my favorite quotes says, “If I have seen further it is by standing on the shoulders of giants.” There really have been some giants that have led RAQAB. I’m looking forward to building on their successes.