Day 1Monday, 12 December 2022 - ET (Eastern Time, GMT-05:00)

Showing 1 of 1 Streams

Quality and Validation - Day 1

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

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