Making the Leap to Paperless Validation

Extended Learning
Learning Level: Intermediate
Time: 1100 - 1300 ET
Session Length: 2 hours

Why do we continue to qualify and validate our systems and equipment on paper and what are the issues? How do we move forward to an electronic alternative?

The paper-based validation process has become expensive, time consuming, and labor intensive. It is a bureaucratic process focused on the creation of templates printed on paper, time spent in the collection of evidence, preparing and storage of documentation and folders, and sequential signature collection based on workflow review. As of today, a number of paperless systems have become available on the market with the focus of addressing these issues and providing a platform that automatically and electronically manages the validation lifecycle. This webinar will provide an overview of the paperless validation approach, key issues to be addressed in the selection of a system, provide a case study example an implementation effort currently underway at Novo Nordisk, Sartorius, and Genmab A/S.


Learning Objectives

  1. Gain understanding of the constructs of the digitized validation approach
  2. Develop the approach for transition from paper based to electronic
  3. Benefits of implementation and recent lessons learned

Speakers

Steven J. Wisniewski
Principal Compliance Consultant
CAI
Peter Werner Christensen, CPIP
Head of QA/RA
Drizzle Life
Hivzo Cehajic
Senior Quality Professional
Novo Nordisk A/S
Frank Guthof
BPS Product Development - Software
Sartorius Stedim Systems GmbH
Mikael Yde
Senior Manager IT QA
Genmab A/S
Michael Herlov Jensen
Principal Consultant
NNIT A/S

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