Governance and Change Control according to GxP and GMP Requirements
February 14 - 15, 2019 - Raleigh ON CAWebinar Compliance
info@webinarcompliance.com
Phone:1-416-915-4458
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. Learning Objectives: Interpret the requirements of the FDA, EU and ICH guidelines regarding compliant Change Control records Understand all the required components of a thorough Change Control record Understand all the elements of effective Change Control management: How to develop a cross-functional team to ensure proper evaluation, approval and implementation of proposed changes Ensure changes do not negatively impact the business or established marketing authorization How to incorporate a Quality risk based approach to evaluating proposed changes Ensure changes are implemented in a timely manner by effective use of the Change Control Review Board (CCRB) and Quality Metrics Understand what steps should be taken post implementation to confirm the objectives were achieved