Created by: Fred Ohsiek, Cleaning Validation ExpertThis article not only applies to high potent (HP) active pharmaceutical ingredient (API) manufacturing, but it also includes pharmaceutical manufacturing products with HP APIs; therefore, the term “HPAPI manufacturing” and “HPAPI product” applies to both types of production.It is important that the requirements for the finished manufacturing companies are […]
Created by: Matthew Jackson, Validation Manager, Torbay PharmaceuticalsThis article was based on my session, Cleaning Validation Program Design: Risk-based Lifecycle Approach, delivered at the KENX’s Cleanroom Validation, Disinfection & Environmental Monitoring Conference April 27-29, 2022 Virtually and in person in Philadelphia, PA.KENX-Insight_Matthew-Jackson_Cleaning-Validation-Program-Design_August-2022-1Download
Created by: Fred Ohsiek, Cleaning Validation ExpertDeveloping an automated clean-in-place (CIP) recipe is a challenging activity for project such as a new facility, equipment or wing addition to an existing facility, a new product, or optimizing a legacy cleaning process. This article will focus on developing the automated CIP process for a new facility, but […]
Presented by: John Wrenn, Country Manager, Australia & New Zealand , CAICleaning validation can be a confusing topic for many people as there can seem to be conflicting information and guidance. This webinar will give you a broad overview of cleaning validation and describe the history and fundamentals of cleaning validation and how we arrived […]
Presented by: Connie Leech, Global Director Quality, Compliance & Regulatory Affairs , CAITop Reasons to watchComprehensive Overview: Get a comprehensive overview of Annex 1 and its role in ensuring the sterility and quality of medicinal products, empowering you with essential knowledge for your role in the industry. Expert Insights: Gain valuable insights from industry experts […]
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