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