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​Date: December 20, 2021
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Date: December 22, 2021
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Investigating Out-of-Specification (OOS) Test Results in the Laboratory – FDA’s Expectations​
​Course Duration: 60 Minutes

Preclinical Testing for Drug and Biologics: Meeting FDA Requirements Without Breaking the Bank
​​​Course Duration: 60 Minutes

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

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

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

5 Steps to Finding the Best Sites for Your Clinical Trial
Course Duration: 60 Minutes​

How to “Win” FDA’s Support for Your Clinical Development Program
Course Duration: 60 Minutes​

​Is Your Facility Validated for cGMP? 5 Steps to Compliance with FDA​Course Duration: 60 Minutes​
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How to Make Sure Your Foreign Vendor is FDA Compliant and Stays That Way
​​​​Course Duration: 60 Minutes

FDA Rules for Use of Social Media in Marketing Regulated Products
Course Duration: 60 Minutes

How to Ace an FDA Meeting
Course Duration: 60 Minutes

​How to Withstand an FDA Audit of Your Facility
Course Duration: 60 Minutes

FDA Regulation of Dietary Supplement Imports into the US
​​​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
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Trial Master File (TMF): FDA Expectations from Sponsors and Sites​
​Course Duration: 60 Minutes​​​​​

New 510k for Modified 510k-Cleared or 510k-Exempt Devices: Best Practices​
​Course Duration: 60 Minutes

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

Expedited Approval Pathways in the US: Best Ways to Get the Most Incentives​
Course Duration: 90 Minutes
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​New Rules for FDA Regulation for Lab Developed Diagnostic Tests(LDT)
​Course Duration: 60 Minutes

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

​FDA Compliant QC and QA Practices: How to Create a Perfect FDA Audit-Ready QMS
​Course Duration: 60 Minutes

​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

​Strategies for 510(k) Applications for Software or Software Containing Medical Devices​
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

​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
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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