This Change Control training program 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.
Why Should You Attend:
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.
At the completion of this course, attendees will be able to:
1. Interpret the requirements of the FDA, EU and ICH guidelines regarding compliant Change Control records.
2. Understand all the required components of a thorough Change Control record.
3. Understand all the elements of effective Change Control management:
Areas Covered in the Webinar:
Topic 1: Regulatory Guidance Review
Topic 2: Review all Elements of a Change Control Record
Who Will Benefit:
Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment
Recorded video session
Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.
Utilizing strategic thinking, risk-based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.