PDA’s Quality Week is devoted to focusing on the principles and applications of Quality Risk Management (QRM). The first conference of week is devoted to the regulatory landscape that outlines the regulatory expectations for establishing a comprehensive risk management program. Attendees to this two-day conference will gain an understanding of the regulatory complexity of QRM principles and how ICH Q9 concepts are being used by industry today to improve and streamline their operations.
Dr. Janet Woodcock, Center Director, CDER, U.S. FDA, will kick off the first day of the event as one of the keynote speakers during the Opening Plenary session. She will discuss the FDA’s perspective on ICH Q9 risk management concepts and how the Agency employs them in their operations.
In addition to Dr. Woodcock’s perspective, Thomas Stanton from Johns Hopkins University will discuss how Enterprise Risk Management can be leveraged successfully within a company’s culture.
The Conference boasts an impressive lineup of speakers, including Martin VanTrieste, CEO, Civica Inc., and Immediate Past Chair, PDA Board of Directors, who explore how risk identification and risk management resulted in the creation of Civica, Inc. Civica was established to address drug shortages through partnering with healthcare systems to ensure that generic drugs are affordable and available as soon as possible.
Dr. Martin Nemec, Health Canada, will focus on risk management concepts from Health Canada’s perspective. Insight into how risk management works when dealing with complex combination products will be provided by Melissa Burns, FDA, and Doug Hamann, AstraZeneca. Guy Villax, CEO, Hovione, and Dr. Lucinda Buhse, FDA, will offer perspective on how risk models are being utilized during inspections and how a good risk management program can result in a positive inspectional outcome.
The second day of this opening Conference will focus on integrating QRM into a company’s quality systems operations. Sessions will delve into how an effective QRM program can assist in evaluating and managing the risk presented when there is a deviation and how QRM can potentially assist in expediting post-approval manufacturing changes.
The second day will also feature a session devoted to exploring the implementation of ICH Q9 from an industry and regulatory perspective. It will look at some of the common pitfalls companies have faced trying to implement ICH Q9 and identify potential improvements for future revisions. Attendees will have an opportunity to learn about the ICH process and offer their ideas on how to improve ICH Q9 through an interactive lunch session featuring two experts who are on the ICH Q9 working group: Gregg Claycamp, FDA, and Stephan Roenninger, Amgen.
The final session for this first of three in this series will discuss Quality Risk Management with respect to high-risk aseptic processing operations, including how QRM can be successfully used as an aid in establishing a comprehensive contamination control strategy.
Don’t miss this first Conference of 2019 PDA Quality Week to gain a better understanding of current QRM global regulatory expectations and how regulatory agencies are using risk-based decisions to determine inspection frequencies and provide oversight.