Assessment of Changing Regulatory Landscape on Analytical Development and Validations for Pharmaceutical Drug Products
Description:
What: The organized contributed symposium purpose is two-fold a) review changing landscape of regulatory requirements for development and validations of analytical procedures and b) assess impacts on regulatory submission and post-approval change controls of these procedures in Pharmaceutical drug products. Although Pharma companies have relied on USP <1225> and ICH Q2(R1), and FDA guidance documents for analytical validations for about 20 years, a lack of ICH guideline on analytical development has been a long standing gap. Furthermore, ICH Q2(R1) is not directly applicable to analytical procedures such as Near Infrared (NIR) Spectroscopy. These concerns have been addressed in the recently published ICH Q2(R2) and ICH Q14 guidelines. Additionally, USP has published new or revisions to a few general chapters of relevance to analytical procedures, e.g., <621>, <761>, and modernization of general chapters and monographs.
How and Why: The regulatory landscape has dramatically changed just in the past few months and will undoubtedly impact analytical development for new drug products and post-approval changes! Renowned speakers from small to large pharmaceutical companies, compendia, and FDA will present their experience and opinions on these important analytical developments at this symposium. The session will be of absolute benefit to Quality, Regulatory, and Business leaders in Pharmaceutical industry for the industry scientists and leaders to benchmark their strategies and approaches and drive path forward. The Philadelphia venue will be a great fit for this Pharmaceutical-Analytical areas because of its proximity to many Pharma companies, FDA, and USP. Therefore, we think the symposium will be a big draw for PITTCON 2023.
Organizer: Shreekant Karmarkar - DAT Pharma Consulting, Inc.
Biography: Dr. Shreekant Karmarkar has twenty years of leadership experience in analytical development, validations, & transfers of methods for small molecule & peptide, injection, solid dosage, and emulsion, drug products that are terminally sterilized or aseptically filled, in syringes, vials, and flexible containers from his career at Baxter Healthcare and as an independent consultant. Dr. Karmarkar has successfully organized symposia related to analytical development at PITTCON, AAPS, and other conferences. His areas of expertise include establishing analytical controls, Analytical Quality by Design (AQbD), reference standard qualification, characterization, & continued suitability of use studies, data integrity, root cause analysis & resolutions of CAPAs and OOS, & strategies and authorship of 3.2.S and 3.2.P CMC sections. His experience in program management includes CRO/CMO management and establishing Analytical Center of Excellence.
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Horacio Pappa - USP
Mark Argentine - Eli Lilly
Shreekant Karmarkar - DAT Pharma Consulting, Inc.
Yang Liu - USP
Christina Szabo - Baxter
Catharine Layton - Waters Corporation
Michael Lally - Lighthouse Instruments
Richard Verseput - S-Matrix
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ICHQ14 and USP Chapter <1220>: historical perspective and the path forward in Analytical QbD
HORACIO PAPPA - US Pharmacopeia
ICH Q14: An Enabler for Analytical Procedure Lifecycle Which Ensures Robustness of Analytical Methods During a Drug’s Lifetime
Cindy Hammill - Eli Lilly and Company
A newly revised ICHQ2 and analytical validations
Shreekant Karmarkar - DAT Pharma Consulting, Inc.
Application of General Chapter <1220> in the Development of Procedure for Quantitative NMR
Yang Liu - U.S. Pharmacopeial Convention
Proposed revisions to USP <761> and <1761> and Applications of NMR to Pharmaceutical Drug Products
Christina Szabo - Baxter International
Changes to analytical procedures related USP general chapter, <621> Chromatography
Andrew Argo - Waters
The new USP<922> Water Activity chapter expands requirements beyond USP<921> Water Determination testing
Jeff Horsman - Lighthouse Instruments
Impacts of USP Modernization Initiatives on Analytical Development for Drug Products
Richard Verseput - S-Matrix Corporation
Assessment of Changing Regulatory Landscape on Analytical Development and Validations for Pharmaceutical Drug Products
Description
Session Number: O24-00
Session Type: Organized
Session Date: Wednesday 3/22/2023
Session Time: 1:30 PM - 4:25 PM
Room Number: 120A
Track: Pharmaceutical
Category: Gas Chromatography, Liquid Chromatography, Pharmaceutical/Biologics
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