Controlling Change to meet GMP Requirements (Medical Device Train)
Venue: Online Event
|Event Date/Time: Sep 09, 2010||End Date/Time: Sep 09, 2010|
This webinar will discuss and evaluate the effects that the recent call for change in the FDA has on a company. It focuses on one of the key contributor to product quality problems and GMP compliance failings -- its change control policies and systems. Change can be beneficial, but is often the cause of new and even worse problems than those the change was designed to eliminate. Proper change control is required to resolve any underlying compliance issues or product problems that are increasingly seen by regulatory agencies and consumers worldwide. To meet this new regulatory climate and be competitive, companies need to recognized what constitutes a "change", and then continually reevaluate their change control system and its interfaces, as well as its impact on all areas of a companyâ€™s cGMP activities.
This webinar will provide valuable assistance to all regulated companies in evaluating their existing or anticipated change control activities and documentation requirements, especially in light of the changes in the FDA's stance vis a vis industry compliance and past problems. It will help attendees understand and recognize the most common change control failings and their fixes, and assist in defining and recognizing changes.
Areas Covered in the Seminar:
Defining a "change" and "change control".
Tougher FDA Expectations / Requirements.
FDA "Hot Buttons".
Document Control; Archiving.
Preventing negative changes and entropy.
Maintain a â€˜state of controlâ€™.