Introduction to USP 1220 Analytical Procedures Life Cycle and Implications of ICH Q14 and Q2(R2) Guidelines

This presentation will provide an overview of analytical quality by design (AQbD) principles and the evolution of QbD in the pharmaceutical development environment.

A brief introduction to the new USP chapter <1220> Analytical Procedures Life Cycle will also be given, including a short case study on stage 1 — procedure design. Additionally, key aspects of the new ICH Q14/Q2(R2) draft guidelines will be discussed along with their implications.

Presenter: Amanda Guiraldelli, PhD (Scientific Affairs Manager, U.S. Pharmacopeia)

Amanda Guiraldelli has been with USP since 2012 and holds the position of scientific affairs manager and principal scientist in the compendial science group-general chapters. She also serves as scientific liaison for the USP Measurement and Data Quality Expert Committee, where she works to develop and revise USP standards related to analytical procedure lifecycle/validation.

Previously, Amanda worked as senior scientist at the USP reference standard laboratory for 8 years with characterization of compendial standards. She is visiting professor at the Institute of Chemistry at the University of Campinas (UNICAMP) in Brazil and is a frequent speaker and instructor on topics related to analytical procedure life cycle, analytical quality by design (AQbD) and chromatography. Amanda is a specialist in mass spectrometry, chromatography, omics, and chemometrics and has more than 15 years of experience in pharmaceutical R&D areas.

Presenter: Manu Grover (M.S. (Pharm), Business Development Manager, Agilent Technologies, Inc.)

Manu has more than 21 years of pharmaceutical industry and chromatography experience. He has worked in the fields of manufacturing and analytical research to support IND, NDA, and ANDA filings in pharmaceutical companies like Dr. Reddy's, Panacea Biotec, and Ozone Pharmaceuticals. In the course of his professional journey, Manu has developed and validated many analytical methods on HPLC, GC, particle sizing, DSC, pXRD, LC/MS, and more. He has successfully filed multiple analytical dossiers in the US and EU markets, filed analytical methods to USP, and handled multiple US FDA audits.