Change Control Best Practices - Avoiding Unintended Consequences of Changes

With FDA citing inadequate change control constantly in its 483s and Warning Letters, the prerequisite to ensure that changes are accurately described, justified, assessed for risk, implemented, and documented has come to the fore. Changes must also be prospectively reviewed by appropriate subject matter experts. Furthermore, certain major changes (e.g. manufacturing, specifications) may require regulatory filings and/or prior regulatory approval.

Learning Objectives:

On completing this course on FDA compliance, participants will be able to:

Understand regulatory requirements and FDA expectations for change control

Understand the purpose of change control

Identify what types of changes are /are not subject to change control

Properly describe a change

Properly justify a change

Who Will Benefit:

This course is designed from a pharmaceutical manufacturing perspective; however, since the main focus is on techniques and practices, the course material may be equally applied to biologics and medical device environments. It will benefit:

Change proposal authors

Reviewers / approvers of change controls

Change control system owners

Production staff / management

Engineering staff / management

Note:

Use coupon code 232082 and get 10% off on registration.

For Registration:

http://www.complianceonline.com/fda-change-control-expectations-best-practices-seminar-training-80244SEM-prdsm?channel=sciencedz