In the past decades, there has been a change in the scrutiny of the way EMEA or FDA regulators looked at E&L data. They have gradually increased the requirements, not backed up with any official document (Guidance, guideline…) which left the Pharmaceutical Industry in the dark, second guessing of what the current position and requirements are of regulators to support a submission.
In this presentation, the key factors of success of any given E&L project will be highlighted. Crucial is to understand what regulators really want and to align the design space of an E&L study to their expectations.
Facing the reality of the ever-evolving regulatory landscape, analytical testing labs need to be on the forefront with expertise in the field of extractables and leachables testing and state-of –the art technology. Meeting the development needs and requirements, of the pharmaceutical and biopharmaceutical industries, also raises the bar for material suppliers.
Only through successful partnering between drug product vendors, material suppliers and the CRO performing the test, a true mitigation of the risk related to packing can be established.
This webinar is part of our 2-day live, pharma webinar series “Pharmaceutical Sterility Assurance, Contamination Control, and Extractables & Leachables” which will be held on 30 September and 1 October 2020. These webinars, presented by Expert Advisors from Sterigenics, Nelson Labs and Noxilizer are designed to bring you insights into the latest developments and innovations in Pharma Sterilization (Sterilization technologies & sterility assurance), Extractables & Leachables testing (Instruments & techniques & regulatory requirements), as well as Bacterial Endotoxin testing.
Webinars in this series include:
- Key Elements of a Sterility Assurance Program
- Gamma Radiation & EO/NO2 Sterilization: Concepts & Pharma Applications
- Bacterial Endotoxin Testing; History, Inhibition/Enhancement, & Process Control
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