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:
Attend the live webinar on Tuesday, March 5, at:
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