Webinar On "ICH Q 10 Change Management System"

Event Details

Time: December 6, 2018 from 1pm to 2:30pm
Location: Online
Street: 9106 Seven Locks Road
City/Town: Bethesda
Website or Map: https://www.compliancetrainin…
Phone: 1-844-216-5230
Event Type: online/webinar
Organized By: Sam Miller
Latest Activity: Nov 27, 2018

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Event Description

Description :

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.

Areas Covered in the Session :

Why an organization needs change control
How change control fits into the pharmaceutical quality system
The change control process

Who Will Benefit:

Senior management
Middle management
line personnel
Quality Assurance personnel

About Speaker:

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.