Governance and Change Control according to GxP and GMP Requirements
November 15 - 16, 2018 - Raleigh, ON CAWebinar Compliance
info@webinarcompliance.com
Phone:416-915-4438\58
Regulatory agencies require pharmaceutical and medical device companies to have a systematic approach to managing all changes made to a facility, their product or a quality system. Given the fact that changes are inevitable, it is essential that companies have a compliant and effective change control program to ensure that no unnecessary or cGMP non-compliant changes occur. This Change Control training course will discuss regulatory expectations from the FDA, EU and ICH perspective, review all the required components of a thorough Change Control program; as well as, discuss the elements regarding successful management an effective Change Control system.