Faculty: Kelly Thomas | Code: FDB3082
Pharmaceutical and medical device companies are required by regulatory agencies to have a systematic approach especially when it comes to managing all changes made to a facility, the product or the quality system. Change is inevitable; however, it is essential that companies have a compliant and effective change control program. This will ensure that no unnecessary or non-compliant cGMP changes occur. This Change Control training session will discuss FDA, EU and ICH regulatory expectations. All the necessary components of a systematic Change Control program in accordance to Gxp and GMP requirements will be reviewed in detail. We will also discuss the elements to successful management an effective Change Control system
Lecture 1: GxP/GMP Framework
Lecture 2: Information Governance
Lecture 3: Change Control Procedure
Lecture 4: Change Control Procedure for Information Technology (IT) Systems
Lecture 5: Data Security
Lecture 6: Crisis Management
Lecture 7: Change Management and User Adoption
Who Should Attend:
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.