Strategies for REGULATORY AUDITS AND INSPECTIONS to meet FDA Expectations
Venue: La Jolla Marriott
|Event Date/Time: Dec 10, 2007||End Date/Time: Dec 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.