Process changes made during the manufacture of recombinant proteins can have profound implications on the quality, safety, efficacy and regulatory approval of your product.
This essential 2-day course gives you a practical insight into how to manage process change so as to ensure regulatory compliance and product consistency at all times. With more than 20 industry case studies to work on, this course is your ultimate guide to finding the best ways to satisfy the needs of the Regulators and understand how various process changes may impact the success of your product.
A regulatory professional with over 20 years experience, Cecil Nick joined PAREXEL in February 2001 and has been involved with drug development and biotech, NCE and orphan drug submissions. He has also authored many articles published in Regulatory Affairs Journal and GCP Journal, which most recently include articles on Biocomparability and Biogenerics
Connect with the PTI faculty! PTI is a global pharmaceutical training company with over 60 interctive courses focusing on Regulatory Affairs, R&D, Clinical, Business Strategy, Fine Chemicals, Biopharmaceuticals, Manufacturing, Medical Devices and Agrochemicals