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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

Effective Environmental Monitoring Plans
Six "Must Have" Factors to Assure Contamination Control
Wednesday,  March  10,  2010 

Phase IV Trials Mandated by FDAAA
With Great Power Comes Great Responsibility
Thursday,  March  4,  2010 

Combination Product Classifications and cGMPs
Former FDA Official Helps You Navigate the Minefield
Thursday,  Feb.  25,  2010 

Medical Device Complaint Systems
Strategies for Managing Your Biggest Compliance Challenge
Wednesday,  Feb.  24,  2010 

REMS Assessment Design and Protocol
Tackling the #1 Misunderstood REMS Requirement
Tuesday,  Feb.  23,  2010 

Cleaning Validation Risks
Front-Line Strategies for an Effective and Compliant Program
Thursday,  Feb.  11,  2010 

Serious Adverse Event Reporting for OTCs and Dietary Supplements
Confusion Reigns and Labeling Enforcement Looms
Tuesday,  Feb.  9,  2010 

Adverse Event Compliance in Drug and Biologic Clinical Trials
Know What to Report, When and How
Thursday,  Jan.  28,  2010 

GLP Compliance:
10 Steps to an Audit-Ready Laboratory
Tuesday,  Jan.  26,  2010 

Form 483 and Warning Letter Responses
Critical Component of the FDA's New "Get Tough" Enforcement
Tuesday,  Jan.  12,  2010 

Managing Clinical Investigators in 2010 and Beyond
FDA’s Final Guidance for Investigator Responsibilities
Thursday,  Dec.  17,  2009 

Fixed-Combination Drugs
New Business Models Drive Profits, Patent Protection
Wednesday,  Dec.  16,  2009 

Reducing Human Error on the Manufacturing Floor
Assuring Effective CAPAs
Tuesday,  Dec.  8,  2009 

Negotiating an FDA Import Hold
Strategies For Challenging FDA Findings
Tuesday,  Dec.  1,  2009 

Medical Device Social Media Advertising
Strategies for Success

Thursday,  Nov.  19,  2009 
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