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

Wednesday, March 25, 2020 - 9:00am

The webinar has been recorded and is available for purchase. Please select the links for pricing and forms.

The joint PDA IPEC risk assessment for excipient technical report has recently been published. The report provides guidance to drug manufacturers on how to tackle the risk assessments for excipients used in finished drugs and provides several examples that can be used by manufacturers 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 were 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 continuous improvement
• Fine-tune their risk assessment process to meet the ever-increasing expectations of regulators for risk assessments

Presenter(s)

Frithjof Holtz

Senior Expert Regulatory Intelligence Life Science, Regulatory Management
Merck KGaA, Darmstadt, Germany / IPEC Europe Chair

Frithjof Holtz is a biologist who has been working for nearly 30 years for Merck KGaA, Darmstadt, Germany. He has experience in operations, Quality Assurance and has held several positions in Regulatory Management (CMC) in Merck Life Science. Recently he has been working with a number of industry associations (e.g. Rx-360, APIC, EFCG, PDA, IPEC) and is currently a senior expert responsible for regulatory intelligence for Merck LS.

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
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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
571-814-3449 or email ipecamer@ipecamericas.org