Learning Level: Basic
Time: 1000 - 1100 EDT 
Session Length: 1 hour

Baseline Guide Vol 5: Commissioning & Qualification 2nd EditionAsset Life Cycle Management evolves in the healthcare manufacturing landscape, based on Good Engineering Practices and QRM as outlined in Baseline Guide 5 Commissioning and Qualification 2nd edition. Engineering Change Management (ECM) plays a crucial role in this context to drive improvement, innovation, and excellence in pharmaceutical manufacturing. Throughout this hour-long webinar, you will hear from industry leaders who will discuss the application of ECM in different stages of asset life cycle and provide examples to demonstrate the ECM specifics in each of these stages. 

Learning Objectives

  • Exploring the role of Engineering Change Management throughout the different stages in Asset Life Cycle
  • Recognizing the importance of Engineering Change Management in pharmaceutical manufacturing, in coordination with Quality Change Control
  • Understanding how to benefit from the application of ECM and, depending on the stage in asset life cycle, when to apply Quality Change Control.

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Joerg Block, PhD
Self Employed
Formerly With Bayer AG Pharmaceuticals
Lori K. Kim
Vice President, Technical Operations
PSC Biotech Corp
Michael Westerman
Vice President, CQV Operations
IPS - Integrated Project Services, LLC