Preparing for 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 for its intended purpose..
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 by the laboratory.
• 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 analytical 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 initial USP expert panel for Validation, Verification and Transfer of Analytical Procedures and a member of a USP Chemical Medicines Monograph expert review committee. She continues to be an USP expert volunteer. Pauline is also a member of The Royal Society of Chemistry, UK and is listed on their current directory for consultants.
|Course Date||Nov-24, 2020 9:00 am|
|Course End Date||Nov-24, 2020 11:30 am|
|Registration Start Date||Oct 14, 2020|
|Cut off date||Nov 23, 2020|
|Course Leader||Pauline L. McGregor, Ph.D. CChem, MRSC|