This change control webinar will discuss the change control activities and documentation required to meet GMP requirements.
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.
- Areas impacted.
- FDA "Hot Buttons".
- Design Control.
- Document Control; Archiving.
- Identifying "changes".
- Preventing negative changes and entropy.
- Maintain a state of control .
Who Will Benefit:This information applies to personnel / companies in the Pharmaceutical, Medical Device, Diagnostic, Neutraceutical and Biologics fields. The employees who will benefit include:
- Senior management
- Regulatory affairs
- Quality Assurance / QAE
- Production
- Engineering, R&D, and software development and testing teams
