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 […]
Presented by: Rui Almeida, Director, Product Life Cycle Management Services, ValGenesis. Inc.Cleaning validation is a complex process. Over the years, the industry has moved on with a structured risk based lifecycle approach following FDA Process Validation Lifecycle principal guidance. Using old processes, it remains a challenge to eliminate human errors. This presentation shows how to […]
Presented by: Cindy Duhigg, Global Validation Steward, Alcon• Application of QbD for cleaning validation• Recognition that acceptance criteria are NOT goals• Determining what qualifies as a “toxicological evaluation”?• Discerning order from the chaos of all the health-based acronymsTakeaway Tools• Case study: Establishing formal health-based exposure limits
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