QRM Based Integrated C&Q Series - Engineering Change Management

Complimentary
Learning Level: Intermediate
Time: 1100 - 1200 EDT 
Session Length: 1 hour

Disclaimer

This webinar was originally hosted last September, and the content remains largely the same with only slight modifications. While most of the material is unchanged, minor updates have been made to enhance the presentation.

Asset 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

  1. Exploring the role of Engineering Change Management throughout the different stages in Asset Life Cycle
  2. Recognizing the importance of Engineering Change Management in pharmaceutical manufacturing, in coordination with Quality Change Control
  3. 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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Speakers

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