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Date: May 16, 2022


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​​​Date: July 14, 2022



​​​Date: July 18, 2022


​​​Date: July 20, 2022


​​​Date: July 25, 2022


​​​Date: July 27, 2022



​​​Date: July 29, 2022

How Apply for a Breakthrough Therapy Designation and Win It
​​​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

​Regulatory Strategies for Small and Medium Companies
Course Duration: 60 Minutes

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

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

Five Steps to Manage the Temporary Shutdown and Restart of a GMP Facility
Course Duration: 60 Minutes
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Strategies for 510(k) Applications for Software or Software Containing Medical Devices​
Course Duration: 60 Minutes

​How to Train Yourselves to be a Good Technical Writer
​Course Duration: 60 Minutes​

​​How to Create Flow Charts for Your SOPs: Visual Tools for Increased Compliance
Course Duration: 60 Minutes

Social media as a recruitment tool for clinical trials: The Best, the Worst, and the Balanced 
​Course Duration: 60 Minutes

10 Steps to the Perfect Clinical Trial Protocol: FDA-Compliant Protocol Development​
​​​​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

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

​FDA Compliant Vendor Validation Programs
Course Duration: 60 Minutes

FDA Compliant Use of Smartphone, Smartwatch, and Apps in Clinical Trials 
Course Duration: 60 Minutes​

How to Write Perfect FDA-Compliant SOPs: Stepwise Instructions
Course Duration: 60 Minutes​

Software Validation: Avoiding FDA Warning Letters and Consent Decree
Course Duration: 60 Minutes

FDA Regulated Import and Export of Medical Devices 
​Course Duration: 60 Minutes​

Good Tissue Practices and GMP for HCT/P and Stem Cell Therapies
​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 Regulation of Dietary Supplement Imports into the US
​​​Course Duration: 60 Minutes​​​
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