An Introduction to Analytical Procedure (Method) Lifecycle Management: Register for Our Upcoming Webinar with Experts from the US Pharmacopeia and Pharmaceutical Industry
Learn about the benefits of the Method Lifecycle Management approach and how to implement this approach in your lab
15 Feb 2019
The pharmaceutical industry relies on data generated by analytical methods for many critical decisions. Traditional approaches consist of distinct exercises — method development, validation, transfer, verification — with limited understanding of the effect of variation on method performance.
The Method Lifecycle Management (MLCM) approach is a holistic approach encompassing all activities from method development to validation, routine use, change control and retirement of the method. This enhanced approach improves the method understanding and performance, leads to fewer out-of-specification results (OOS), facilitates method transfer and has the potential to lessen the regulatory burden.
On Tuesday, March 5, we’ll be joined by Dr. Horacio Pappa, Director of General Chapters at the United States Pharmacopeia, Dr. Alexander Schmidt, Founder and CEO of Chromicent Pharmaceutical Services, and Mijo Stanic, Co-founder, General Manager and Technical Director of Chromicent Pharmaceutical Services, for a webinar covering the fundamentals of the Method Lifecycle Management approach, its benefits to drug manufacturers and patients, and the current thinking of the USP, FDA and ICH. Case studies will showcase how this approach is being implemented in the pharmaceutical industry.
The webinar will cover:
- How Method Lifecycle Management (MLCM) improves method understanding and robustness, by identifying and controlling the sources of variability
- Current thinking of the USP and regulatory bodies with an emphasis on USP proposed chapter <1220>
- Concrete examples on the implementation and impact of the lifecycle approach
Attend the live webinar on Tuesday, March 5, at:
- 15:00 GMT
- 10:00 EST
- 07:00 PST
- 16:00 CET
Interested, but have a scheduling conflict? Register to watch the webinar on demand at a time more suitable for you.
SelectScience runs 3-4 webinars a month across various scientific topics, discover more of our upcoming webinars>>
