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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.
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
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.