Title: The challenges of achieving and maintaining Regulatory CMC Compliance
Duration: 1 hour, 2 minutes
The complexity of Pharmaceutical operations makes Chemistry, Manufacturing and Control (CMC) compliance increasingly difficult to achieve and sustain. Often, CMC compliance programmes 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.
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 programmes.