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Date:  July 27, 2020
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​How to Apply for Emergency Use Authorizations (EUA) for Various FDA Regulated Products

3D Printing for Manufacturing Regulated Products: FDA’s Current Acceptance and Future Projections
​​​Course Duration: 60 Minutes

How and When to Use a US Agent When Dealing with the FDA​​
Course Duration: 60 Minutes
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Software Validation: Avoiding FDA Warning Letters and Consent Decree
Course Duration: 60 Minutes

How to Find the Best CRO for Your Clinical Trial
​​Course Duration: 60 Minutes

How to Make Efficient FDA-Compliant Clinical Protocol Amendments
​Course Duration: 60 Minutes

How to Train Yourselves to be a Good Technical Writer
​Course Duration: 60 Minutes​
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FDA Regulated Import and Export of Medical Devices 
​Course Duration: 60 Minutes

Development and Marketing of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps) in the US
Course Duration: 60 Minutes

Managing Supplies in Your Clinical Trial: FDA Compliant Supply Chain Management​​​
​Course Duration: 60 Minutes​​

Managing Your Business Through a Pandemic - Disaster Management, Recovery and Business Continuity SOPs

​How to Increase the Odds for Success of Your 505(b)(2) Product
Course Duration: 60 Minutes​

Raw Materials Risk Management in GMP Facilities Avoiding GMP Non-Compliance
​​​Course Duration: 60 Minutes

Safety Reporting in Clinical Trials: Are you Compliant with the Current FDA Rules?
​​​Course Duration: 60 Minutes

FDA Rules for Cybersecurity Measures in Regulated Products
Course Duration: 60 Minutes

FDA Regulation of Molecular Diagnostics
​​​Course Duration: 60 Minutes

​Regulatory Issues with Developing Companion Diagnostics: FDA Policies and Expectations Clarified
​​​Course Duration: 60 Minutes

Using Excel Spreadsheets in FDA Regulated Environment
Course Duration: 60 Minutes

​Avoid Data Integrity Issues: How to Audit a CRO and Other Vendors
Course Duration: 60 Minutes

FDA's Guidance on Process Validation for Drugs and Biologics - 3 Steps to Compliance
Course Duration: 60 Minutes