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The new joint PDA IPEC risk assessment for excipients technical report has recently been published. The report provides guidance to industry on how to tackle risk assessments and provides several examples that can be used by companies in their quality programs. The document also provides a mechanism to review existing programs and fine-tune the risk assessment process to align with industry best practices.
Presenter(s)
Janeen Skutnik-Wilkinson
Ms. Skutnik is the Associate Director for Quality Intelligence at Biogen, the chair of PDA’s Pharmacopoeial interest group and the current Chair of IPEC Americas. Her former positions include: Vice President at NSF DBA,.Director /Team Leader of Quality & Regulatory Policy at Pfizer, responsible for working with various trade associations and also developing Pfizer Positions on Quality and CMC issues. She has over 25 years experience and expertise in compendial activities, quality and regulatory policy, and has held a variety of positions with responsibilities in documentation, change control, analytical method validation and product launch. Ms. Skutnik earned a Bachelors of Science from the University of Connecticut in 1994. She is a member of the ICH IWG for ICH Q3D Elemental Impurities, and was also on the EWG for Q3D. She was the Chair of PhRMA’s Compendial Liaison Team (2000-2012); and the PhRMA Topic Leader for the ICH Topic – Q4B Regulatory Acceptance of Pharmacopoeial Interchangeability. She is the IPEC Delegate to the ICH Assembly and ICH Informal Quality Discussion Group.