Change Control Under the cGMPs and How the Regulations are Changing (FDA Validation)

Venue: Online Event

Location: Palo Alto, California, United States

Event Date/Time: Oct 24, 2011 End Date/Time: Oct 24, 2011
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These tiered, risk based processes, discusses in this training, will allow low risk changes to be implemented quickly and simply yet exert appropriate checks and controls on those which can have high impact on your operational success and your regulatory standing. These tiered systems allow you to rapidly change your strategy when regulatory requirements change. We will include models of systems that will allow you to benchmark your processes to determine whether they are as robust and efficient as you believe. Examples of where companies failed to live up to the regulatory agency expectations will be presented that enable you to see what exactly the agencies are looking for and why.

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.


Online Event
2600 E. Bayshore Road
Palo Alto
United States