Laboratory Transfer and Verification of Analytical Procedures - Integrating Future Philosophies into Current Practice
Many analytical procedures which require transfer / verification come to us with inherent problems. These don’t magically disappear during transfer or verification process but instead can cost us a lot of time, money and effort to resolve issues, either at the time of transfer or in routine use. We may get lucky if we use the best of everything (equipment, analyst etc). Although this may seem the best chance of success to tick that compliance box, it is not good science as it does not challenge the test procedure. Also, we tend not to test sufficient samples or even the correct samples in order to challenge future performance.
The exercise to qualify our method in our laboratory for routine use is often viewed as something that has to be done to check a compliance requirement. We need to change our way of thinking towards this exercise and bring back the science! It helps when we recognise that this exercise provides a great opportunity to understand the procedure, include any validation deficiencies and additional controls and really challenge it. In other words, address the fear of failure head on with knowledge, understanding and good science, rather than cross our fingers and toes and hope we get through it first time! Identifying and addressing the issues as part of the transfer/verification process will set the procedure up for success throughout its lifecycle.
In this 3 hour webinar, modern concepts such as QbD philosophies i.e risk assessment and method understanding are combined with our current practices to ensure a smoother method transfer process, a more robust performance, leading to fewer lab incidents/OOS results due to poor procedure perfomance in routine use.
Who should attend
Analytical Chemists, Supervisors and Managers involved in the technical transfer or verification of analytical procedures
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 MRSC 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. She has been involved in the evolution of the application of this topic since 2010.
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 a 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-17, 2020 9:00 am|
|Course End Date||Nov-17, 2020 12:00 pm|
|Registration Start Date||Oct 14, 2020|
|Cut off date||Nov 16, 2020|
|Course Leader||Pauline L. McGregor, P.h.D. CChem MRSC|