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.

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

​​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
​
Software Validation: Avoiding FDA Warning Letters and Consent Decree
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

How to Make Efficient FDA-Compliant Clinical Protocol Amendments
​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

FDA’s Requirements for a Dear Doctor Letter
​​​​Course Duration: 60 Minutes

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

​Workflow Management in Clinical Trial Projects: Learning from the FDA
​Course Duration: 60 Minutes

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

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

Five Steps to Manage the Temporary Shutdown and Restart of a GMP Facility
​Course Duration: 60 Minutes

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

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

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

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

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

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

What is Allowed and What is Still Banned per FDA’s New Off-Label Promotion Guidance
Course Duration: 60 Minutes
​
Avoid Data Integrity Issues: How to Audit a CRO and Other Vendors
​Course Duration: 60 Minutes
​
Investigating Out-of-Specification (OOS) Test Results in the Laboratory – FDA’s Expectations​
​Course Duration: 60 Minutes

Best Practices for Writing an Investigator’s Brochure
​Course Duration: 60 Minutes​​

​10 Steps to the Perfect Clinical Trial Protocol: FDA-Compliant Protocol Development​
​​​​Course Duration: 60 Minutes

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

​New Rules for FDA Regulation for Lab Developed Diagnostic Tests(LDT)
​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