Regulatory Guidelines on Analytical Method Development: USFDA, ICH and USP Perspective

The successful regulatory filing of any pharmaceutical product development dossier relies on scientific and rational way of analytical method development.

There are many analytical development strategies which can be followed like “Traditional” or “Enhanced approach”. Enhanced Approach as stated by ICH, or DoE based Quality-by-Design (QbD) approach are one of such method development strategies which will be discussed in webinar. These approaches are now part of regulations across USP, ICH and USFDA. We will also discuss the different concepts like ATP, Lifecycle Management, Risk Assessment etc. Join us for this webinar to understand different guidelines related to analytical development and how can you adopt QbD or Enhanced approach in the analytical method development.

Presenter: Manu Grover (Business Development Manager – Pharma Markets, Agilent Technologies, Inc.)

Manu Grover holds a postgraduate degree in Pharmacy from Manipal Academy, India. He has more than 21 years of chromatography experience and has worked in pharmaceuticals to support IND, NDA, and ANDA filings incompanies such as Dr. Reddy's, Panacea Biotec, and Ozone Pharmaceuticals. During his professional journey, he has developed and validated analytical methods on HPLC, GC, particle sizing, DSC, pXRD, and LC/MS instruments, as well as successfully filing multiple analytical dossiers in U.S./EU markets. In his current role, he works closely with the Agilent sales team, regulators, and pharmaceutical scientists. He shares market updates, trends, and expertise related tothe Agilent portfolio of columns and supplies.