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> FDA Pharmaceutical and Medical Device Training and Conference CDs & Transcripts
FDA Pharmaceutical and Medical Device Training and Conference CDs & Transcripts
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Requirements for Effective Environmental Monitoring Plans
Six “Must-Have” Factors to Assure Contamination Control
Thursday, Feb. 23, 2012
Pharma/Device Social Media: What You Can and Can’t Do Today
Understanding the FDA’s Recent Guidance and Next Steps
Wednesday, Feb. 22, 2012
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
Surviving the FDA’s New PREDICT Import Screening Program
National Rollout Nearly Complete — Impact Already in Effect
Wednesday, Sept. 28, 2011
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