Presented by:Calvin Kim, Head of Quality Systems and Validation, Samsung Biologics Suju Hwang, Senior Manager, Digital Quality & Compliance, Samsung Biologics• Gain insight on how key strategy & framework are established in consideration of risk-based approach in CSA and Part 11 requirements• Understand the importance of aligning R&R across CSV relevant processes & stakeholders• Determine […]
Presented by:Marc Koetter, Senior Manager Computer System Validation & IT Governance, Fresenius Medical Care• Understand the difference between scripted and unscripted testing• Identify variants of unscripted testing• Lear how to minimize test documentation burden whilst gaining maximum test coverage by using unscripted testing• Understand the compliance of unscripted testing with the regulations• Learn when 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
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 […]
