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33818 Conferences

Preparing for FDA Inspections in a Changing Regulatory Environment - Webinar by GlobalCompliancePanel

Added by davidross759 on 2010-09-02

Conference Dates:

Start Date Start Date: 2010-09-22
Last Date Last Day: 2010-09-22

Conference Contact Info:

Contact Person Contact Person: Manzoor
Email Email:
Address Address: Online Training Webinar, Online, DE, 19801, United States
Phone Tel: 800-447-9407
Phone Fax: 302-288-6884

Conference Description:

Ready for Inspection by Hamburg's FDA? Under Commissioner Hamburg's new enforcement policy, FDA has issued more warning letters more quickly than it has in years. In some cases, the agency has even skipped warnings and gone straight from inspectional observations to injunctions and seizures. Clearly, the stakes will be higher at your next inspection. The question is: What steps should you take now to be ready for it?

The key to effective management of regulatory inspections is effective preparation. Being well organized and confident during the inspection means that your firm gives it's best possible performance which in turn gives the regulatory inspector the clear message that you know your business thoroughly. In this webinar, you will learn the key principles of the preparation of staff that will be expected to face the inspector(s).
This webinar was developed to help participants to determine what actions are needed to build a robust system for handling regulatory inspections.

Areas Covered in the Session:

* Current trends
* Staff Training and Preparation
* Key steps to becoming inspection ready
* Facing the inspector - Competent, Confident, Credible, Knowledgeable
* Managing the inspection process
o Use of high level presentations
o Likely targets
o Know and respect the inspector's techniques
o Behaviors to encourage
o Behaviors to avoid

Who Will Benefit:Recommended for compliance, legal, management, quality, regulatory, and technical personnel who directly interface with the FDA during inspections. The employees who will benefit include:

* Regulatory Unit
* QA Unit
* Manufacturing
* Validation
* Consultants
* Quality system auditors
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