PDA and the IPEC Federation Publish Technical Report No. 54-6: Formalized Risk Assessment for Excipients - Webinar

Wednesday, March 25, 2020 - 9:00am

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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.

Learning Objectives

Attendees will be able to:
• Understand the risk assessment framework
• Walk away with examples to apply in their company’s internal risk assessment program
• Develop a strategy to review existing programs and identify areas for improvement
• Fine-tune their risk assessment process to meet the ever-increasing expectations of regulators for risk assessments

 

Presenter(s)

Janeen Skutnik-Wilkinson

Associate Director, Quality Intelligence
Biogen

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.

 

Cancellation Policy

Note:

Cancellations for live webinars must be made in writing and can be mailed or e-mailed to:

IPEC-Americas Webinars
3138 10th Street N
Arlington, VA 22201
Suite 500
E-mail: ipecamer@ipecamericas.org

Registration fees are refundable for attendees registered for individual webinars, if cancellation is received at least five (5) business days prior to the course. Notices of cancellation received 0-4 business days prior to the course will not be provided a refund. If you registered and are unable to attend the webinar, a recording of the webinar will be provided.

No cancellations are available for webcasts (archived recorded webinars). Recordings are available for 21 days after purchase.

Questions?
Please contact IPEC-Americas Training Coordinator
571-814-3450 or email ipecamer@ipecamericas.org