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Langue du site : Français - English
Réf : 29575
Evènement :Transfer of Analytical Methods according to USP <1224>

Date :Vendredi 17 Mai 2019

Lieu :Palo Alto
2479 East Bayshore Road,
Suite 200
94303 Palo Alto, California, États-Unis

Type :Conférence & Séminaire - Audience Internationale

Accréditation :--


 

Informations

Editorial

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.

Objectives

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.

Program

  • Method transfer approaches
  • Setting appropriate acceptance criteria
  • Preparing for method transfer
  • Is the method suitable?
  • Managing risk in the method transfer process
  • Common method transfer problems
  • Contingency planning in the event of method transfer failure
  • A risk-based approach to method transfer documentation

Speakers

Mark Powell

Mark Powell
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.

 
 
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Lieu

Plan et itinéraire
Adresse de la conférence :
Palo Alto
2479 East Bayshore Road,
Suite 200
94303 Palo Alto
California, États-Unis
Tél : +1-888-717-2436
Plan et itinéraire

Renseignements

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Précisions

Transfer of Analytical Methods according to USP <1224> Management
analytical method transfer, analytical method transfer problems, method transfer process, analytical method transfer approach, method transfer failure
Professionnels, Analytical development QC QA Regulatory affairs
10 -- --
English

Divers

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