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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

Spreadsheet Validation
Tools and Techniques to Meet FDA Requirements

Tuesday, Dec. 11, 2012

International Drug and Device Recalls
Proactive Planning for FDA, WHO, EMA and Health Canada

Tuesday, Dec. 4, 2012

Responding to Clinical Trial Inspectional Observations and FDA 483s

Tuesday, Nov. 27, 2012

How Not to Ruin a Perfectly Good Product With a Flawed Study Design

Wednesday, Nov. 14, 2012

Creating, Staffing and Managing an Inspection War Room
Your First Line of Defense

Thursday, Nov. 8, 2012

FDA-adopted Columbia-Suicide Severity Rating Scale (C-SSRS) Categories for Prospective Assessment
Improving Precision of Identification and Safety Monitoring, Optimizing Data Collection While Avoiding False Signals and Decreasing Burden

Thursday, Oct. 25, 2012

Going “E” With Informed Consent for Clinical Trials

Thursday, Oct. 18, 2012

Medical Device Software Recalls on the Rise
What’s Causing Them, What the FDA is Doing About Them, and What Manufacturers Should Do to Prevent Them

Tuesday, Sept. 25, 2012

Off-the-Shelf Versus Custom-Built Quality Systems
What Works, What Doesn’t and Why

Tuesday, Sept. 18, 2012

Your Clinical SOPs Are Too Long!
Reduce Wordy SOPs to Improve Compliance

Thursday, Sept. 13, 2012

Medical Device Mobile Apps
What Needs FDA Approval

Thursday, Aug. 30, 2012

Managing EMA Drug Process Validation
Comparing and Contrasting the EMA and FDA’s Process Validation Guidelines

Wednesday, Aug. 29, 2012

MDUFA 2012
First-Hand Knowledge for Medical Device Companies

Thursday, Aug. 9, 2012

Insider Insight on PDUFA V
How Will the Changes Impact You?

Tuesday, Aug. 7, 2012

Complying with FDA’s Unique Device Identification Rule

Tuesday, July 31, 2012

FDA Pharmaceutical and Medical Device Training and Conference CDs & Transcripts

Spreadsheet ValidationTools and Techniques to Meet FDA Requirements

International Drug and Device RecallsProactive Planning for FDA, WHO, EMA and Health Canada

Responding to Clinical Trial Inspectional Observations and FDA 483s

How Not to Ruin a Perfectly Good Product With a Flawed Study Design

Creating, Staffing and Managing an Inspection War Room Your First Line of Defense

FDA-adopted Columbia-Suicide Severity Rating Scale (C-SSRS) Categories for Prospective Assessment Improving Precision of Identification and Safety Monitoring, Optimizing Data Collection While Avoiding False Signals and Decreasing Burden

Going “E” With Informed Consent for Clinical Trials

Medical Device Software Recalls on the Rise What’s Causing Them, What the FDA is Doing About Them, and What Manufacturers Should Do to Prevent Them

Off-the-Shelf Versus Custom-Built Quality Systems What Works, What Doesn’t and Why

Your Clinical SOPs Are Too Long! Reduce Wordy SOPs to Improve Compliance

Medical Device Mobile Apps What Needs FDA Approval

Managing EMA Drug Process Validation Comparing and Contrasting the EMA and FDA’s Process Validation Guidelines

MDUFA 2012First-Hand Knowledge for Medical Device Companies

Insider Insight on PDUFA VHow Will the Changes Impact You?