Excipient Risk Assessment as per the EU Guidance and SMARTRISK as a solution

1 December 2020 | 3PM CET


agenda

What to expect.

EU Guidelines on the formalized risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use were introduced in March 2015 at the same time as updates to EudraLex Volume 4, Part 1, Chapter 3 and 5. This guideline was introduced to provide a method for the assessment of the risks associated with excipients used in medicinal products, the establishment of the appropriate level of GMP control based on this risk and assessment of excipient suppliers risk profile against the chosen controls. 

The excipient risk assessment methodology sits outside the supplier management program but provides a valuable connection between the requirements of an excipient in a product formulation and the ability of a supplier to provide an excipient with the desired characteristics. This webinar will discuss the key points in the performance of a compliant excipient risk assessment and how the PharmaLex tool, SMARTRISK, can help provide a solution for Marketing Authorization Holders that need support with the management of Excipient risk. 


speakers

A full hour of inspirational speakers.

 

 

Kate Coleman

Director/Senior Consultant, Quality and Compliance, PharmaLex

Kate is a Quality professional with 18 years experience in the Pharmaceutical Industry across several platforms including Biologics, Sterile Fill Finish, High Potency oncology and Solid Oral Dose products. Kate is an SME in Quality Risk Management and works with her clients to deliver and remediate QRM programs providing efficiency and clarity across the product lifecycle.


Why Attend

The key learnings include:

  •  Gaining an understanding of the full requirements for Excipient Risk Assessment according to the EU Guidelines of 19th March 2015 - on the formalized risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use
  •  Identifying where the Excipient Risk Assessment sits in your overall Quality Risk Management plan?
  •  Understanding how SMARTRISK can provide a solution for compliance with the requirement for an Excipient Risk Assessment.

Register

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