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.

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

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

FDA Rules for Cybersecurity Measures in Regulated Products
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

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

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

FDA's Guidance on Process Validation for Drugs and Biologics - 3 Steps to 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