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35118 Conferences

Major CGMP Issues for 2012 - Webinar By ComplianceOnline

Added by Referral on 2012-01-05

Conference Dates:

Start Date Start Date: 2012-01-10
Last Date Last Day: 2012-01-10

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:

U. S. FDA-regulated companies are responsible for understanding current Good Manufacturing Practices as defined in the Code of Federal Regulations ( 21 CFR Part 111, 210/211, and 820). They are then required to translate those regulations into procedures and work instructions.

Many companies who have successfully done that in the past are now failing audits, facing major recall, and multi-million dollar fines. What failures in the GMPs have led to this? What assumptions have proven to be invalid? This webinar will address the above and all of the following:

What are the key areas of non-compliance?
What are the 'new' areas for increased awareness, focus, and remediation? What new concerns need to be addressed now?
What are the trends and areas of FDA concern on which to focus in the coming year? What approaches are now mandated?
How does ICH Q_ documents provide guidance for all FDA regulated industries, not just pharmaceuticals?
Where does Product Risk Management fit into the process?
How to maximize any remedial action process against scarce resources?

For Registration: rce/control/trainingFocus/~product_id=70 2185?channel=worldconf
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