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[Tcd-hackers] Validation Requirements & Compliance Strategies for FDA Re


From: ComplianceOnline
Subject: [Tcd-hackers] Validation Requirements & Compliance Strategies for FDA Regulated Environment
Date: Wed, 23 Aug 2006 14:32:06 +0200 (SAST)

Wednesday, 23 August 2006
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Thursday August 24, 2006
10:30 AM PDT | 1:30 PM EDT
Process Validation Requirements & Compliance Strategies for FDA Regulated Environment
Instructor: Jose Mora, is a Sr. Consultant at Streale as well as a partner in Atzari Consulting, LLC.
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Tuesday August 29, 2006
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Setting up a QSR Compliant CAPA SystemEnvironment
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Tuesday August 29, 2006
10:00 AM PDT | 1:00 PM EDT
Adequate Filter Selection and Integrity Testing
Instructor: Miguel Montalvo,Owner and President of Expert Validation Consulting, Inc.
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Tuesday August 29, 2006
10:30 AM PDT | 1:30 PM EDT
Reducing the Cost of Creating Documents for FDA-Regulated Industries
Instructor: Chris Whalley, Founder and CEO, Doxpub, Inc.
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Tuesday August 29, 2006
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Complying with 21CFR Part 11-Understanding the Role of Predicate Rules
Instructor: Tony Dunbar, Compliance Specialist.
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Wednesday August 30, 2006
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FDA Inspections-Dos & Don'ts
Instructor: Ashish Talati, Associate at Amin Law, LLC.
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Catching Up on Computer System Validation: Meeting FDA and ISO 13485: 2003 Requirements
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