On-Demand Webinars

​Following is a list of webinars which happened recently. You can choose one or more of the following webinars and we will send you the webinar materials, audio/video so that you can listen/watch at your ease.

​Expedited Approval Pathways in the US: Best Ways to Get the Most Incentives​
Course Duration: 90 Minutes

Good Documentation Practices for FDA-Regulated Industry
​Course Duration: 60 Minutes

How Apply for a Breakthrough Therapy Designation and Win It
​​​Course Duration: 60 Minutes
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CMC Considerations for INDs and NDAs for 505(b)(2) Products
Course Duration: 60 Minutes

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

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

​FDA's Guidance on Process Validation for Drugs and Biologics - 3 Steps to Compliance
Course Duration: 60 Minutes
​​
Regulatory Strategies for Small and Medium Companies
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

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

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

How to “Win” FDA’s Support for Your Clinical Development Program
Course Duration: 60 Minutes​
​
Preclinical Testing for Drug and Biologics: Meeting FDA Requirements Without Breaking the Bank
​​​Course Duration: 60 Minutes

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

How to Ace an FDA Meeting
Course Duration: 60 Minutes

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

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

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

Adverse Event Reporting Requirements for Dietary Supplements and OTC Drugs​
Course Duration: 60 Minutes​

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

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

​How to Use FDA’s Guidance Documents To Your Advantage
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​

FDA Compliant Warehouse and Distribution Practices
Course Duration: 60 Minutes​

Five Best Practices for Using Email in FDA Regulated Industry
Course Duration: 60 Minutes
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​How to Find the Best CRO for Your Clinical Trial
​​Course Duration: 60 Minutes

FDA Approved Adaptive Clinical Trials: Smart Trial Design for Drugs, Biologics and Devices​
Course Duration: 60 Minutes​

How and When to Use a US Agent When Dealing with the FDA​​
Course Duration: 60 Minutes

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

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

​FDA Regulation of Dietary Supplement Imports into the US
​​​Course Duration: 60 Minutes​​​
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​Managing Your Business Through a Pandemic - Disaster Management, Recovery and Business Continuity SOPs
Course Duration: 60 Minutes
​
How to Apply for Emergency Use Authorizations (EUA) for Various FDA Regulated Products
​​​Course Duration: 60 Minutes

Medical Device Reimbursement: The Right Questions to Ask
​Course Duration: 60 Minutes​​

Best Practices to meet CMS Sanitary Condition Requirements under Food and Nutrition Services 
​​​Course Duration: 60 Minutes

Legal and Regulatory Requirements for Cannabidiol (CBD) Based Pharmaceuticals and Related Products
​​​Course Duration: 60 Minutes

Import of FDA Regulated Products into the US: FDA and Custom’s Requirements at the Port of Entry
Course Duration: 60 Minutes

How to Prepare for a Meeting with EMA and Other European Regulatory Agencies for Drugs and Biologics
Course Duration: 60 Minutes  

​​​Export of FDA Regulated Products from US to Other countries: Export Certificates and Other Documents
Course Duration: 60 Minutes   

​Sales Team Training Requirements to Avoid Off-label Promotion: Best Practices for Social Media
​Course Duration: 60 Minutes