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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

Between a Rock and a Hard Place:
FDA's Labeling Rule and Liability Lawsuits
Wednesday,  June  27,  2007 

Reportedly Trained or Truly Trained:
Developing GMP Training That Works
Tuesday,  June  26,  2007 

Medical Device Quality Audits:
10 Must-Haves to Meet QS Requirements
Monday,  June  25,  2007 

Clinical Trial Billing Under Medicare
Negotiate Trial Budgets to Steer Clear of the OIG
Thursday,  June  14,  2007 

Writing and Enforcing Effective SOPs
Avoid Regulatory Action and Improve Efficiency
Tuesday,  June  12,  2007 

Drug and Biopharma Marketing in China:
Secrets for Success in the World's Largest Growth Market
Thursday,  May  31,  2007 

Audit Trail Management:
Avoid Setting Off Warning Bells During Your Next Inspection
Wednesday,  May  30,  2007 

Adverse Event Compliance in Drug and Biologic Clinical Trials
Know What to Report, When and How
Wednesday,  May  30,  2007 

Institutional Review Board Compliance:
Real-World Strategies for Sponsors, Investigators and IRBs
Thursday,  May  24,  2007 

Monitoring Medical Device Clinical Trials
Effective Monitoring Techniques for Quality Research
Tuesday,  May  22,  2007 

Advisory Committee Meetings
Secrets for Success Despite Tough New Rules
Tuesday,  May  15,  2007 

DDMAC Warning Letters:
Avoid Regulatory Action
Wednesday,  May  9,  2007 

Clinical Trial Inspections:
What a Former FDA Inspector Can Tell You About Noncompliance
Tuesday,  May  8,  2007 

Assure FDA Compliance
Design and Execute Effective SOPs for Clinical Trials
Thursday,  April  26,  2007 

Surviving an FDA Disgorgement Action:
Frontline Strategies to Defend Against the FDA's Billion-Dollar Enforcement Tool
Tuesday,  April  24,  2007 
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