Conference Description:
This course offers a unique perspective and is a succinct overview of best practices that can really help you avoid these compliance situations, described above
In this course, you learn how to properly manage FDA during an inspection, how to impact the FDA decision-makers, and how to respond to FDA 483 Observations. In addition, the course will show you how to strategically address compliance issues and avoid a Warning Letter
Since FDA continues to crack down on cGMP violators and issuing 483s and Warning Letters as well as ordering shut-downs and investigations for non-compliance, the potential for millions of dollars lost is not worth the risk. If a firm proactively addresses compliance issues during and following an FDA inspection, then this preparation can save QA and Regulatory professionals manpower, time and money.
Areas Covered in the Seminar:
Inspectional preparations and logistics.
Manage the FDA Investigator for the best outcome.
Influence FDA decision-makers.
Properly accept FDA 483.
Respond strategically to FDA 483.
Develop a strategic Corrective Action Plan.
Intercept and Avoid a Warning Letter.
For More details:
http://bit.ly/97EZsW
Start Date: 2010-09-30
Last Day: 2010-09-30
Contact Person: admin
Email: admin@complianceonline.com
Address:
2600 E. Bayshore Road, Palo Alto, CA, 94303, United States
Tel: 650-620-3915
Fax: 650-963-2556
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