Enhanced Approach Versus Traditional Approach for Analytical Procedures. What’s the Difference?
This webinar summarises and discusses the differences between the two approaches.
The objectives of the webinar are:
- To highlight key concepts and strategies of the enhanced approach for analytical procedures
- Put them in context and compare them to the traditional approach.
- Summarise some of the challenges and benefits of the enhanced approach
- Help you start your journey towards using more robust analytcal procedures.
This 3 hour webinar provides a useful platform to succinctly present the key concepts and differences of the two approaches and help you get started on your journey towards developing/transferring more robust analytical procedures.
In view of the pending new guidance, ICH Q14: Analytical Procedure Development and Revision of Q2(R1) Analytical Validation, due for publication next year, its time to find out what the differences are.
- Overview of Traditional approach
- Why change? Problems experienced using the traditional approach
- Overview of Enhanced Approach
- Key Concepts and Strategies
- High level differences
- Differences in more detail and comparisons
- Challenges and benefits of the Enhanced Approach
- Q and A session
Who Should Attend?
This Webinar is valuable for anyone involved in developing, validating, transferring or verifying analytical procedures for the testing of pharmaceutical materials and would like to know more about the enhanced approach for analytical procedures, how it is different from the traditional approach and how ito improve the performance 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 analytical procedures, quality systems and GMP regulations.
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 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-10, 2020 9:00 am|
|Course End Date||Nov-10, 2020 12:00 pm|
|Registration Start Date||Oct 14, 2020|
|Cut off date||Nov 09, 2020|
|Course Leader||Pauline L. McGregor, Ph.D. CChem, MRSC|