Transfer of Analytical Methods according to USP <1224>

Speaker

Instructor: Mark Powell
Product ID: 706036

Location
  • Duration: 60 Min
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.
RECORDED TRAINING
Last Recorded Date: Jun-2021

 

$229.00
1 Person Unlimited viewing for 6 month info Recorded Link and Ref. material will be available in My CO Section
(For multiple locations contact Customer Care)

$399.00
Downloadable file is for usage in one location only. info Downloadable link along with the materials will be emailed within 2 business days
(For multiple locations contact Customer Care)

 

 

Customer Care

Fax: +1-650-362-2367

Email: [email protected]

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Why Should You Attend:

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:

  • 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

Who Will Benefit:

This webinar is intended for pharmaceutical scientists responsible for planning, executing or reviewing method transfer activities, including:

  • Analytical development
  • QC
  • QA
  • Regulatory affairs
Instructor Profile:
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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Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
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. ComplianceOnline 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. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).

 

 

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