The requirement for the Quality Unit review and approval of document changes is clear in 21CFR211. However, contemporary regulatory expectations for the control of change goes well beyond document change review. The expanded expectation for change control and the Quality Unit responsibilities in the change control process was introduced into the FDA regulated industries in 1996 when it became a requirement for medical devices and was part of the proposed amendments to 212CFR211. Since that Change Control has been an element of the Quality System approach found in ICH Q10 and related guidances. It is important that all individuals involved in the pharmaceutical industry understand the expectations for change control in the everyday pharmaceutical firm operations. In this webinar we will discuss the egulatdory expectations for change control and how change control fits into the pharmaceutical quality system.

1. The evolution of change control into regulatory expectations
2. Why an organization needs change control
3. How change control fits into the pharmaceutical quality system
4. The change control process

• personnel at all levels of a pharmaceutical firm
• Senior management
• Middle management
• line personnel
• Quality Assurance personnel

John G. (Jerry) Lanese is an independent consultant with a focus on Quality Systems and the components of an effective Quality System. He received a BA and MS from Middlebury College and a Ph.D. in Analytical Chemistry from the University of Michigan and began his career teaching Analytical Chemistry in a small liberal arts college. Dr. Lanese moved from the academic environment to the pharmaceutical industry where he has managed Analytical Research, Quality Control and Quality Assurance functions. 

In 1994 Dr. Lanese formed his own company, The Lanese Group, and since that time he has been a consultant in the area of quality system and cGMP compliance and has audited and consulted with small and large medical device and pharmaceutical companies, including companies under FDA Consent Decree, API and excipient manufacturers, electronic firms and other manufacturing organizations.