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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

Managing Data Integrity and Part 11 Compliance for Device Suppliers
Do It Right or Get a Warning Letter

Tuesday, Jan. 31, 2012

Controlling Cross-Contamination in Outsourced Manufacturing
Expert Guidance to Assure CMO Compliance

Thursday, Jan. 26, 2012

Registering “Applicable Trial” Data on ClinicalTrials.gov
Managing Disclosure of Negative or Non-significant Results

Tuesday, Jan. 24, 2012

Device Contract Manufacturer and Supplier Management
Solutions for Solving Your #1 Headache

Wednesday, Dec. 14, 2011

CAPA Is King
Tools, Tips and Techniques for Assuring Compliance

Tuesday, Dec. 13, 2011

Organizing Data and Document Archives
Best Practices for Acing Your Next FDA Inspection

Thursday, Nov. 17, 2011

eCTD Requirements Under PDUFA V
INDs, NDAs, BLAs in eCTD Format Will Be Required

Wednesday, Nov. 16, 2011

Adaptive Clinical Trial Design and Model-Based Drug Development

Thursday, Nov. 10, 2011

Marketed Unapproved Drugs
FDA to Take Immediate Enforcement Action at Any Time, Without Prior Notice

Thursday, Oct. 27, 2011

Reduce Human Error on the Drug and Device Manufacturing Floor
Assure Effective CAPAs

Tuesday, Oct. 25, 2011

Spreadsheet Validation
Tools and Techniques to Meet FDA Requirements

Tuesday, Oct. 25, 2011

Social Media Strategies for Drug & Device Companies
Practical Tips and Tools to Use in the Absence of FDA Guidance

Thursday, Sept. 29, 2011 • 10:00 a.m. - 4:45 p.m.

Surviving the FDA’s New PREDICT Import Screening Program
National Rollout Nearly Complete — Impact Already in Effect

Wednesday, Sept. 28, 2011

Form 483 and Warning Letter Responses
View from the Front Lines of the FDA’s New “Get Tough” Enforcement Strategy

Thursday, Sept. 22, 2011

QSR Data and Trending
Overlooked FDA Regs That Are Becoming a Top Priority

Tuesday, Sept. 13, 2011

FDA Pharmaceutical and Medical Device Training and Conference CDs & Transcripts

Managing Data Integrity and Part 11 Compliance for Device Suppliers Do It Right or Get a Warning Letter

Controlling Cross-Contamination in Outsourced Manufacturing Expert Guidance to Assure CMO Compliance

Registering “Applicable Trial” Data on ClinicalTrials.gov Managing Disclosure of Negative or Non-significant Results

Device Contract Manufacturer and Supplier Management Solutions for Solving Your #1 Headache

CAPA Is King Tools, Tips and Techniques for Assuring Compliance

Organizing Data and Document Archives Best Practices for Acing Your Next FDA Inspection

eCTD Requirements Under PDUFA V INDs, NDAs, BLAs in eCTD Format Will Be Required

Adaptive Clinical Trial Design and Model-Based Drug Development

Marketed Unapproved Drugs FDA to Take Immediate Enforcement Action at Any Time, Without Prior Notice

Reduce Human Error on the Drug and Device Manufacturing Floor Assure Effective CAPAs

Spreadsheet Validation Tools and Techniques to Meet FDA Requirements

Social Media Strategies for Drug & Device Companies Practical Tips and Tools to Use in the Absence of FDA Guidance

Surviving the FDA’s New PREDICT Import Screening Program National Rollout Nearly Complete — Impact Already in Effect

Form 483 and Warning Letter Responses View from the Front Lines of the FDA’s New “Get Tough” Enforcement Strategy

QSR Data and Trending Overlooked FDA Regs That Are Becoming a Top Priority

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