Check out the interactive, knowledge sharing industry webinars during July and August 2020!
Contact us to customize an interactive and discussion format webinar to suit your company's training needs
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It is hoped that in classroom training will resume in October.
Thanks to all who participated in one or more of the Social Brain Break sessions. They were lots of fun! Watch this space for the return of this popular event
Preparing and Understanding the Method Transfer Process - (For QA personnel)
So why do we still have problems?
Some of the main issues are:
- The transfer process is viewed from a compliance (not science) perspective
- The transfer process is often combined with testing of samples we want to release
- Not enough samples are tested to gain a realistic projection of future performance
- The testing laboratory is not provided with enough information
- The original validation was inadequate
These issues indicate we don’t take the time to gain an adequate understanding of the test method or how it will operate in a new environment (one other than the lab who validated it). This understanding is essential to the success of the method transfer. It needs to be undertaken prior to the transfer protocol being executed.
We need to adopt the mindset that method transfer is an exercise that adds value and is an investment to ensure robust performance of our methods throughout its period of use.
There are things QA staff can do to make the transfer go more smoothly, efficiently and reduce cost to ensure only value-added testing is performed.
• Introduction and overview of Method Transfers
• Common causes for failure of method transfers
• The transfer team, responsibilities and communication
• The transfer process and how you can help
o Gather Information: resources, documents, gap analysis
o Transfer protocol
o Testing and handling failures
o Transfer Report
o Method approval
• Recap: Tips to Set the transfer up for success
• Q and A Session
Who Should Attend?
This Webinar is valuable for Quality Assurance staff and managers in companies who Import/distribute drugs and may not have a laboratory background but want to be able to gain a more in depth knowledge and understanding of analytcal methods and the transfer process.
What’s included with the webinar?
Each participant will receive:
- A certificate of attendance upon completion
- An electronic copy of the presentation
Pauline McGregor, PhD. CChem has fulfilled a variety of roles in over thirty years in the pharmaceutical industry. She is an expert in quality systems and procedures, GMP regulations and analytical chemistry.
She brings a technical expertise to laboratories which enable her to assist them to develop, transfer, verify and validate analytical procedures, and also optimize efficiency with regards to laboratory operations and troubleshooting in an analytical development and QC environments.
Her current passion is Lifecycle Management of Analytical procedures and application of QbD philosophies to improve method robustness.
As a USP volunteer, Pauline was a proud member of the USP expert panel for Validation, Verification and Transfer of Analytical Procedures and a member of a USP Chemical Medicines Monograph review committee. Pauline is also a member of The Royal Society of Chemistry, UK and is listed on their current directory for consultants.
|Course Date||Aug-11, 2020 9:30 am|
|Course End Date||Aug-11, 2020 11:30 am|
|Registration Start Date||Jun 17, 2020|
|Cut off date||Aug 10, 2020|
|Course Leader||Dr. Pauline McGregor, Ph.D. Chem, MRSC|