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Home > Conferences > FDA Pharmaceutical and Medical Device Training and Conference CDs & Transcripts

FDA Pharmaceutical and Medical Device Training and Conference CDs & Transcripts

Device Off-Label Promotion:
Case Studies to Prepare for Increased Enforcement
Friday,  June  27,  2008 

Biologic-Device Combination Products:
One Size Does Not Fit All
Thursday,  June  26,  2008 

Accurate Budgeting for Patient Recruitment
Thursday,  June  26,  2008 

Writing and Enforcing Effective SOPs
Avoid Regulatory Action and Improve Efficiency
Wednesday,  May  21,  2008 

Combating Counterfeit and Diverted Drugs:
A Lipitor Case Study and Top 10 Strategies for Protecting Your Products
Wednesday,  May  14,  2008 

Understanding the Realities of Clinical Trials in India:
More Than Patient Pools and Cost Savings
Tuesday,  May  13,  2008 

Find and Fix Defects Before Your Devices Go to Market
Using FMEA to Design Defect-free Medical Devices
Wednesday,  April  30,  2008 

Reduce Supply Chain Risks
How the FDA Expects You to Manage Outsourced Suppliers
Tuesday,  April  29,  2008 

Negotiating An FDA Import Hold:
Strategies for Challenging FDA Findings
Monday,  April  28,  2008 

Off-Label Information Dissemination:
Minimize Legal and Regulatory Exposure
Thursday,  April  24,  2008 

Navigating the FDA's New
180-Day Generic Marketing Exclusivity Rulings
Friday,  March  28,  2008 

Using the Best Study Feasibility Model:
Predict Success Early and Often
Thursday,  March  27,  2008 

Drug Pedigrees in California:
January 2009 Compliance
Wednesday,  March  26,  2008 

Going From Approvable to Approved:
Strategies to Avoid the FDA's Backhanded Compliment
Wednesday,  March  19,  2008 

ISO 13485 in the Real World
Identifying and Managing Pain Points in Quality Systems
Wednesday,  March  12,  2008 
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