World Conference Calendar

35118 Conferences

The Tougher U.S. FDA - One Year Later

Added by Referral on 2010-09-17

Conference Dates:

Start Date Start Date: 2010-10-19
Last Date Last Day: 2010-10-19

Conference Contact Info:

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

Conference Description:

This FDA compliance webinar will evaluate the FDA expectations in the near term and further out in the future and how it will boil down to new regulatory climate.

Areas Covered in the Seminar:

* Stated expectations and the one-year result.
* Avoid complacency from past "good" FDA actions.
* Avoid complacency from just completed "good" ISO feedback.
* FDA's desired responses from industry.
* How to respond now -- where to shift focus first.
* Where to direct scarce resources.
* Anticipated future directions.
* 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 / QAE
* Production
* R&D and Engineering
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