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September 4, 2024
FDA Regulated Import and Export of Medical Devices
Course Duration:
60 Minutes
How to Create Flow Charts for Your SOPs: Visual Tools for Increased Compliance
Course Duration:
60 Minutes
FDA Rules for the Content, Tone and Format of an Investigator’s Brochure
Course Duration:
60 Minutes
Drug Master Files – Helping with FDA DMFs
Course Duration:
60 Minutes
Regulatory Strategies for Small and Medium Companies
Course Duration:
60 Minutes
How to Train Yourselves to be a Good Technical Writer
Course Duration:
60 Minutes
Five Steps to Manage the Temporary Shutdown and Restart of a GMP Facility
Course Duration:
60 Minutes
FDA is Changing GMP Audit Practices: Are You Ready?
Course Duration:
60 Minutes
How to “Win” FDA’s Support for Your Clinical Development Program
Course Duration:
60 Minutes
How and When to Use a US Agent When Dealing with the FDA
Course Duration:
60 Minutes
Five Best Practices for Using Email in FDA Regulated Industry
Course Duration:
60 Minutes
How to Write Perfect FDA-Compliant SOPs: Stepwise Instructions
Course Duration:
60 Minutes
FDA Approved Adaptive Clinical Trials: Smart Trial Design for Drugs, Biologics and Devices
Course Duration:
60 Minutes
FDA Permitted Off-Label Promotion of Regulated Products
Course Duration:
60 Minutes
Strategies for 510(k) Applications for Software or Software Containing Medical Devices
Course Duration:
60 Minutes
FDA Regulation of Molecular Diagnostics
Course Duration:
60 Minutes
Software Validation: Avoiding FDA Warning Letters and Consent Decree
Course Duration:
60 Minutes
Raw Materials Risk Management in GMP Facilities Avoiding GMP Non-Compliance
Course Duration:
60 Minutes
FDA Rules for Use of Social Media in Marketing Regulated Products
Course Duration:
60 Minutes
How to Make Efficient FDA-Compliant Clinical Protocol Amendments
Course Duration:
60 Minutes
How to Withstand an FDA Audit of Your Facility
Course Duration:
60 Minutes
How Apply for a Breakthrough Therapy Designation and Win It
Course Duration:
60 Minutes
Avoid Data Integrity Issues: How to Audit a CRO and Other Vendors
Course Duration:
60 Minutes
Trial Master File (TMF): FDA Expectations from Sponsors and Sites
Course Duration:
60 Minutes
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