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

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
​
​New Rules for FDA Regulation for Lab Developed Diagnostic Tests(LDT)
​Course Duration: 60 Minutes

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

New 510k for Modified 510k-Cleared or 510k-Exempt Devices: Best Practices​
​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

Trial Master File (TMF): FDA Expectations from Sponsors and Sites​
​Course Duration: 60 Minutes​​​​​

R​egulatory Perspectives of Clinical Project Management: Meeting FDA Requirements for Clinical Trials​
​Course Duration: 60 Minutes

Five Best Practices for Using Email in FDA Regulated Industry
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​​​

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

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

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

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

​​How to Ace an FDA Meeting
Course Duration: 60 Minutes

Best Practices for Writing an Investigator’s Brochure
​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​
​
​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

​​10 Steps to the Perfect Clinical Trial Protocol: FDA-Compliant Protocol Development​
​​​​Course Duration: 60 Minutes​​
​
How to Create Flow Charts for Your SOPs: Visual Tools for Increased Compliance
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