Unfortunately, all in class training programs and workshops have been cancelled due to the COVID 19 out break. Please observe your local governments advice to keep you and your families safe and healthy.
Changes to PMcG operations until the COVID-19 situation is resolved:
1) Reduced rates on online or telephone consulting sessions
2) Discounted document writing and review service
3) New Professional webinars to help increase efficiency of your operations/processes
Contact us for a customised quote for the above services.
Check out our interactive knowledge sharing industry webinars during April and May!
Start your week on a positive note and give your brain a boost! Sign up and drop in every Monday from April 27th through May 18th. We hope to boost those grey cells, make you laugh and not feel so alone! 10.00am EDT (Duration approx. 20 minutes).
Everyone is welcome! Last Session May 18th.- It's a Brain Blast!
Preparing and Understanding the Method Transfer Process - (Non technical session)
Failures during method transfer continue to be a burden in the pharmaceutical industry, in particular for Importers. The country from which we import the drug states the analytical procedure had been validated. Our contract testing labs are approved by our government agencies to test these products and they are generally extremely competent. 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
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 importers can do to make the transfer go more smoothly, efficiently and reduce cost to ensure only value-added testing is performed.
This webinar explains the process of transfer from a non technical perspective for QA importers that can help you communicate with the testing laboratories to improve the success rate of method transfers and gain an understanding of your procedure and the transfer process.
• 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 drugs and may not have a technical chemistry 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.
Pauline was a member of the USP expert panel for Validation, Verification and Transfer of Analytical Procedures and is currently on a USP Chemical Medicines expert committee. Pauline is also a member of The Royal Society of Chemistry, UK and is on their current directory for consultants.
|Course Date||May-12, 2020 11:00 am|
|Course End Date||May-12, 2020 12:30 pm|
|Registration Start Date||Apr 09, 2020|
|Cut off date||May 11, 2020|
|Course Leader||Dr. Pauline McGregor, Ph.D. Chem, MRSC|