World Conference Calendar

35128 Conferences

Change Control Under the cGMPs and How the Regulations are Changing

Added by Referral on 2011-10-13

Conference Dates:

Start Date Start Date: 2011-10-24
Last Date Last Day: 2011-10-24

Conference Contact Info:

Contact Person Contact Person: Referral
Email Email:
Address Address: 2600 E. Bayshore Road, Palo Alto, California, 94303, United States
Phone Tel: +1-650-620-3915
Phone Fax: +1-650-963-2556

Conference Description:

Why Should You Attend:

This webinar will provide valuable information on the requirements of an effective change control process from an operational and regulatory perspective. It will describe how and when to implement a system that is both cost effective and compliant, in an ever-changing regulatory landscape, keeping appropriate control over the processes and products without burdening the business.

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.
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