In this analytical method transfer webinar attendees will learn the options available for the transfer of validated, non-compendial methods to a different site. In addition to current regulatory guidance, the different options for method transfer will be discussed. The webinar will set out an efficient, risk-based approach that reduces effort whilst meeting the requirements of regulators.
Analytical method transfer is a critical GMP activity that must be performed successfully before the receiving laboratory is considered qualified to run the method. Often, insufficient time is spent planning for method transfer and risks in the method transfer process may not have been adequately considered. This webinar will introduce the concept of quality risk management to the method transfer process. The four types of method transfer (comparative testing, covalidation, revalidation and transfer waiver) will be explained, together with considerations regarding transfer acceptance criteria. Common problems encountered during method transfer (including documentation, equipment, reagents and data processing) will be described, together with approaches to mitigate the risk of failure.
After attending this webinar, participants will be able to select the most appropriate and efficient method transfer approach for a given situation. They will also understand the potential risks involved in the method transfer process, together with the importance of identifying and mitigating them.Areas Covered in the Webinar:
This webinar is intended for pharmaceutical scientists responsible for planning, executing or reviewing method transfer activities, including:
Director, Mark Powell Scientific Limited
Dr Mark Powell is a Fellow of the Royal Society of Chemistry (RSC) with over thirty years’ experience as an analytical chemist. Mark was Honorary Treasurer of the RSC’s Analytical Division and led a working group on continuing professional development until July 2016, when his term of office ended. Between 2003 and 2013, he was the Analytical Development Manager, and later Scientific Manager, of a UK-based contract research organization which specialized in early-stage oral drug development. In 2013, he set up Mark Powell Scientific Limited, which provides training and consultancy services to pharmaceutical companies. Mark has since enjoyed working with companies of all sizes around the world on a variety of training and consultancy assignments.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.
Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.
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