By Jane Weitzel, Quality Control Expert, and USP Council of Experts Member & Chair of the 2020-2025 General Chapters –Measurement and Data QualityFit for intended purpose is a key, central concept for USP <1220> Analytical Procedure Life Cycle, ICH Q2(R2) Validation of Analytical Procedures, and ICH Q14 Analytical Procedure Development. The performance criteria for the […]
Kim Huynh-Ba*, Pharmalytik LLC, and Christopher Latoz, Hollister Incorporated*Corresponding Author: kim.huynhba@pharmalytik.comAbstractPharmaceutical products require expiration dates and storage conditions on their labels, determined through stability studies conducted from clinical trials through post-approval. These studies ensure that any chemical, physical, or microbiological changes over time do not affect the product’s quality, safety, or efficacy. ICH Q1A(R2) provides […]
Presented by: Moderator: Chinmoy Roy, Senior Industry Consultant, ValGenesisPanelists: Rosalind Beasley, Chief Executive Officer, Main and Mission Inc.Roy Devine, Global Process Owner Computer System Validation, BDDaniel Walter, Policy Analyst, CDRH, U.S. FDA
Presented by: Leslie Lighton-Humphreys, Senior Manager Compliance and Process Management, Cencora
Presented by: Saurabh Joshi Shripad, Director for Solutions Engineering, ValGenesis, Inc.Imagine a future where manual paperwork and administrative tasks in commissioning, qualification and validation are reduced to the bare minimum – a future where the transformative power of Digital CQV shapes the pharmaceutical industry towards Pharma 4.0.Join us for an exclusive webinar as we delve into […]
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