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April 30, 2020
How and When to Use a US Agent When Dealing with the FDA
Course Duration:
60 Minutes
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
3D Printing for Manufacturing Regulated Products: FDA’s Current Acceptance and Future Projections
Course Duration:
60 Minutes
How to Make Efficient FDA-Compliant Clinical Protocol Amendments
Course Duration:
60 Minutes
How Apply for a Breakthrough Therapy Designation and Win It
Course Duration:
60 Minutes
Regulatory Strategies for Small and Medium Companies
Course Duration:
60 Minutes
Good Documentation Practices for FDA-Regulated Industry
Course Duration:
60 Minutes
CMC Considerations for INDs and NDAs for 505(b)(2) Products
Course Duration:
60 Minutes
Expedited Approval Pathways in the US: Best Ways to Get the Most Incentives
Course Duration: 90 Minutes
Regulatory Perspectives of Clinical Project Management: Meeting FDA Requirements for Clinical Trials
Course Duration:
60 Minutes
Trial Master File (TMF): FDA Expectations from Sponsors and Sites
Course Duration:
60 Minutes
Five Best Practices for Using Email in FDA Regulated Industry
Course Duration:
60 Minutes
Good Tissue Practices and GMP for HCT/P and Stem Cell Therapies
Course Duration:
60 Minutes
How to Use FDA’s Guidance Documents To Your Advantage
Course Duration:
60 Minutes
Best Practices for Clinical Trial Risk Management: Common Issues and Potential Solutions
Course Duration:
60 Minutes
FDA is Changing GMP Audit Practices: Are You Ready?
Course Duration:
60 Minutes
How to Train Yourselves to be a Good Technical Writer
Course Duration:
60 Minutes
5 Steps to Finding the Best Sites for Your Clinical Trial
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
How to Increase the Odds for Success of Your 505(b)(2) Product
Course Duration:
60 Minutes
FDA IND Submission for a 505(b)(2) Product
Course Duration:
60 Minutes
Opioid Pain Management, FDA Regulations and Requirements for Good Clinical Practice
Course Duration:
90 Minutes
FDA Compliant Use of Smartphone, Smartwatch, and Apps in Clinical Trials
Course Duration:
60 Minutes
Social media as a recruitment tool for clinical trials: The Best, the Worst, and the Balanced
Course Duration:
60 Minutes
Strategies for 510(k) Applications for Software or Software Containing Medical Devices
Course Duration:
60 Minutes
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