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
Unfortunately, a webinar cannot replace a 2 day workshop that includes case studies and practical exercises as well as a greater amount of knowledge sharing and discussion. However, it does provide a useful platform to succinctly present the key concepts and differences of the two approaches.
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 testing of pharmaceutical materials and would like to know more about the enhanced approach for analytical procedures and how it is different from the Traditional approach
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-19, 2020 11:00 am|
|Course End Date||May-19, 2020 12:30 pm|
|Registration Start Date||Apr 09, 2020|
|Cut off date||May 18, 2020|
|Individual Price||plus HST|
|Course Leader||Dr. Pauline McGregor, Ph.D. Chem, MRSC|