Change Control Under the cGMPs and How the Regulations are Changing (FDA Validation)
Venue: Online Event
|Event Date/Time: Oct 24, 2011||End Date/Time: Oct 24, 2011|
Areas Covered in the Seminar:
- Reasons for a robust change control process and the key elements of one.
- When the process should be implemented to add the greatest value and least burden on operations especially in commissioning a new plant?
- How to set up a tiered, risk based system to control at the right level and not over manage or stifle operations.
- Why agencies come down on some companies for deficient change processes so you will avoid these traps and pass muster with these agencies?
- Why separating document from product/process change control is important?
- The value of a multidisciplinary change control committee to manage your operational changes.
- Who must review and approve changes and when to get Regulatory Affairs involved in the process?
- How to implement a change control process into the IT function - a formidable task?
To manage change at a distance with contract manufacturers.