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32801 Conferences

Tougher U.S. FDA cGMP Compliance Audits -- Raising the Bar/ Are You Ready? - FDA Webinar By ComplianceOnline

Added by Referral on 2010-11-18

Conference Dates:

Start Date Start Date: 2011-01-18
Last Date Last Day: 2010-11-30

Conference Contact Info:

Contact Person Contact Person: admin
Email Email: admin@complianceonline.com
Address Address: 2600 E. Bayshore Road, Online Event,Palo Alto, CA, 94303, United States
Phone Tel: 650-620-3915
Phone Fax: 650-963-2556

Conference Description:

This FDA cGMP training webinar will discuss US FDAs approach to cGMP Audits and expectations from companies. It will also evaluate chief concern areas of cGMP compliance audit and anticipatory emphasis changes as per new regulatory climate.

This webinar will provide valuable assistance to all regulated companies in evaluating their existing compliance and internal audit emphasis in light of the changes in the FDA's CGMP audit "paradigm". Once recognizing the danger and likely locations of potential problem areas, a company can evaluate / perform a gap analysis, and then put in place the necessary fixes to ensure continuing compliance.

Areas Covered in the Seminar:

The "target".
Avoid complacency from past "good" FDA audits.
Avoid complacency from just completed "good" ISO audits.
The desired response.
How to respond now -- where to shift focus first.
Where to direct scarce resources.
A risk-based phased approach.
Prove 'in control'.
Maintain 'the edge'.

Who Will Benefit:

This webinar will provide valuable assistance to all regulated companies in evaluating their existing compliance and internal audit emphasis in light of the changes in the FDA's CGMP audit "paradigm". Once recognizing the danger and likely locations of potential problem areas, a company can evaluate / perform a gap analysis, and then put in place the necessary fixes to ensure continuing compliance. This information applies to personnel / companies in the Pharmaceutical, Medical Device, Diagnostic, Nutraceuticals and Biologics fields. The employees who will benefit include:
Senior management
Regulatory Affairs
Quality Assurance
Production
Engineering
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