The challenges of achieving and maintaining Regulatory CMC Compliance

Duration: 1 hour & 2 minutes


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Why watch

Summary

The complexity of Pharmaceutical operations makes Chemistry, Manufacturing and Control (CMC) compliance increasingly difficult to achieve and sustain. Often, CMC compliance programs offer no more than a ‘snap-shot in time’ of compliance.  A strong RA / Quality partnership, however, supporting implementation of transformed systems/processes can provide a sustained compliance outcome.

Key Learnings

  •  Establish a Regulatory CMC compliance baseline
  •  Using a fishbone analysis to highlight key problems 
  •  Tips for securing a successful CMC compliance environment 
speakers

A full day of inspirational speakers

Proud to bring inspirational speakers from across the globe. 

Dr. Adam King

Senior Director Regulatory Affairs

Dr. King has nearly 30 years of experience working in the Pharmaceutical industry, with over 21 years specializing in global Regulatory Affairs and Regulatory Consultancy. He brings along extensive experience in radiopharmaceutical development, regulatory strategy development and oversight of the successful delivery of large scale Regulatory Affairs CMC programs.