Title: The challenges of achieving and maintaining Regulatory CMC Compliance
Date: Thursday, December 05, 2019
Time: 03:00 PM Central European Time
Duration: 1 hour
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.
- Understanding the process steps to establish a Regulatory CMC Compliance baseline
- Use of a ‘fishbone’, analysis to highlight key problem areas in CMC Compliance programmes
- Building the framework of systems and processes to support sustainable CMC Compliance
- Tips for securing a successful and sustainable CMC Compliance outcome
Dr. Adam King
Senior Director Regulatory Affairs PharmaLex
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.
Join Dr. King to discussthe complexity of Pharmaceutical operations, which makes Chemistry, Manufacturing and Control (CMC) compliance increasingly difficult to achieve and sustain. At the end of the session we invite you to take part in the Q&A session.