Regulatory agencies require pharmaceutical and medical device companies to have a systematic approach to managing all changes made to their facilities, products, and/or quality systems. 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-related changes occur. Documentation of change control, including document authoring, updates, archiving, and related activities are not only a critical component of this exercises, but are also mandated by all global health authorities.
This course will discuss regulatory expectations from the FDA, EU and ICH perspective, review all the required components of a thorough change control program, and discuss the elements regarding successful management an effective change control system.
At the completion of this course, attendees will be able to:
- Interpret the requirements of the FDA, EU and ICH guidelines regarding compliant Change control records.
- Explain all the required components of a thorough Change control record
- Recognize the critical aspects of documentation and document control
- Apply all the elements of effective Change control management