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Quality & Validation
December 12 – 13, 2022
Digital Conference8:00AM EST // 1:00PM GMT // 2:00PM CET
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Key Sessions
Paul L. Pluta, PhD
Review of the Basics: Critical Cleaning Validation
Lifecycle Compliance Systems LLC, USA
Rick Mineo
The State of Validation: 2022 Annual Report & Industry Insights
Kneat Solutions, USA
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Day 1 - ET (Eastern Time, GMT-05:00)

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Day 1 - ET (Eastern Time, GMT-05:00)
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Showing 1 of 1 Streams
8:00am - 8:05am
Welcoming Remarks
8:05am - 8:35am
Review of the Basics: Process Validation
  • Strategies and Techniques for Process Validation
  • Process Scaling - Improve processes by optimising utilisation of equipment and optimising quality outputs of equipment.
  • Matthew Jackson - Head of Quality, Torbay and South Devon NHS Foundation Trust, UK
8:35am - 9:05am
Review of the Basics: Qualification of Facilities and Utilities
  • Mauricio Chinchilla Romero - Principal Quality Engineer, Edwards Lifesciences
9:05am - 9:35am
Review of the Basics: Critical Cleaning Validation
  • Paul L. Pluta, PhD - Managing Director, Lifecycle Compliance Systems LLC, USA
9:35am - 9:55am
Coffee Break & Networking
9:55am - 10:25am
Records and Data Integrity: ISPE Definitions
  • Thomas M. Golden - Senior Validation Engineer, Thomas M. Golden LLC, USA
10:25am - 10:55am
The Practical Implementation of Data Integrity Requirements
  • Sara Levy - Computer Systems Validation (CSV) and Data Integrity Consultant, Sara Levy Consulting, Israel
10:55am - 11:15am
Coffee Break & Networking
11:15am - 12:15pm
How can we be Audit/Inspection Ready?
  • Kimberly Trautman - Managing Director and Vice President, MEDIcept Inc., USA
12:15pm - 1:00pm
The State of Validation: 2022 Annual Report & Industry Insights
  • Rick Mineo - Director of Kneat Academy and Strategic Partnerships, Kneat Solutions, USA
1:00pm - 1:15pm
End of Day/ Networking on the Platform
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