This change control webinar will discuss the change control activities and documentation required to meet GMP requirements.
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
