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> FDA Pharmaceutical and Medical Device Training and Conference CDs & Transcripts
FDA Pharmaceutical and Medical Device Training and Conference CDs & Transcripts
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Medical Device Complaints Handling:
Strategies for Managing Your Biggest Compliance Challenge
Wednesday, Aug. 22, 2007
EudraVigilance Deconstructed:
Submitting Compliant EU Adverse Event Reports
Tuesday, Aug. 21, 2007
Clinical Trials in the Developing World:
An On-the-Ground Look at Risks and Best Practices
Thursday, Aug. 16, 2007
New State False Claims Acts:
19 Different Sets of Laws and More on the Way
Wednesday, Aug. 15, 2007
Negotiating Corporate Integrity Agreements
Tuesday, Aug. 14, 2007
Adverse Effect Compliance in Device and Diagnostics Clinical Trials
Know What to Report, When and How
Thursday, July 26, 2007
Preparing for an FDA Preapproval Inspection
Tuesday, July 24, 2007
An FDA Insider's Guide to Pre-IND/IDE Meetings
How to Avoid Clinical Trial Holds
Thursday, July 19, 2007
Quality of Life Claims, Marketing and the FDA
Creating a Competitive Advantage in a Crowded Market
Thursday, July 19, 2007
Managing SAS Validation Processes:
Mastering Five Critical Programming Obstacles
Wednesday, July 18, 2007
New Part 11 Guidance for Clinical Trials
What This Means for You
Tuesday, July 17, 2007
False Claims Act Compliance Strategies:
Don't Lose Access to Medicare and Medicaid Reimbursement
Tuesday, July 17, 2007
Root Cause Analysis
Understand Failures, Exceptions and Nonconformances
Thursday, July 12, 2007
Cleaning Validation Disasters:
Front-line Strategies for an Effective and Compliant Program
Wednesday, July 11, 2007
A World Apart:
Understanding Differences in EU and U.S. Medical Device Regulations
Tuesday, July 10, 2007
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