Strategies for REGULATORY AUDITS AND INSPECTIONS to meet FDA Expectations

Venue: La Jolla Marriott

Location: San Diego, California, United States

Event Date/Time: Dec 10, 2007 End Date/Time: Dec 11, 2007
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Description

SWE Enterprises, Inc. invites you to attend an event you can't afford to miss, the Strategies for REGULATORY AUDITS AND INSPECTIONS to meet FDA Expectations. This Educational Conference event will provide in-depth coverage on Practical Approaches and Experiences for Successful Internal and External Audits and Inspections in the Pharmaceutical, Medical Device and BioTech Industry. It will be held at the La Jolla Marriott in San Diego, CA on December 10-11, 2007!

==> An Update by the PDA regarding the Standard Audit Criteria Task Force and an Extended Session from an Ex-FDA Field Inspector. <==

Register by November 9th and Receive a $300 DISCOUNT at http://www.sweinc.biz. Participate in an Industry Leading Educational Conference at a First-Rate Venue.

Learn the Latest from the Experience of INDUSTRY EXPERTS. Participating Companies include:

* ARENA PHARMACEUTICALS
* QUINTILES CONSULTING
* WYETH PHARMACEUTICALS
* FIRST QUALITY INC
* WATERS CORPORATION
* COMPUTER SYSTEM VALIDATION
* 21 CFR CONSULTING, LLC
* DYNAMIC COMPLIANCE SOLUTIONS

... and many more

To Register, visit http://www.sweinc.biz.


SIX In-Depth CASE STUDIES from Major Pharmaceutical Companies!

* Essential Quality Agreements in the Inspection and Management of CMOs
* Successful Management of an FDA Inspection: Before, During and After
* Experiences from Utilizing an Internal Auditing Program to Improve Internal Processes
* Exploring the Do's and Don'ts When Being Audited
* Auditing Software Vendors
* Experiences from Computer System Validation Auditing and Common Problems
* How to Create an Effective Audit Program

..... and much more

Inclusive is an Workshop by FIRST QUALITY INC regarding Auditing Vendors for Regulated Computer Systems.

Venue