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 holdup […]
Presented by: Anthony Grilli, CEO and Owner, FOCUS LaboratoriesSampling 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 exacerbate […]
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 to […]
Presented by: David W. Vincent, MPH, Ph.D. , Chief Scientific Officer, VTITakeaways:• The main aspects of a robust cleanroom management program• Challenges with cleanroom design and cleanroom materials of construction• Common deviation root causes for environmental monitoring failures• Cleanroom cleaning causing rouge, rust, and yellowing of surfaces• CAPA to improve cleanroom performance Takeaway Tools• Cleanroom […]
Presented by: David W. Vincent, MPH, Ph.D., CEO and Chief Scientific Officer, VTI Life Sciences This Webinar recording will cover the following:Regulatory Requirements: Contamination Control Strategy & Cross Contamination• The view of EU GMP Annex 1• The view of US-FDA: Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice• ASTM – Clean […]
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