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 […]
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
Presented by: David Vincent, Ph.D, Chief Scientific Officer, VTI Life Sciences • Current regulatory expectations• Life cycle approach to cleaning validation (FDA 3 stage approach)• How to gain cleaning process understanding by utilizing risk based approach• CIP and automated systems design and qualification of equipmento equipment selection clean by designo sprayball coverage studieso washout curveo […]
Presented by: Anthony Grilli, CEO and Owner, FOCUS Laboratories Sampling air and surfaces with agar plates for colony forming units in a manufacturing plant to assess effectiveness of contamination controls measures a blunt, labor intensive tool providing data a week or more after sampling. Shortages of media from suppliers due to Covid or natural disasters […]
Presented by: Rui Almedia, 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 […]
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