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 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

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

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

​FDA Regulation of Dietary Supplement Imports into the US
​​​Course Duration: 60 Minutes​​​

​Medical Foods - Practical Tips to Meet FDA Requirements
​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

Social media as a recruitment tool for clinical trials: The Best, the Worst, and the Balanced 
​Course Duration: 60 Minutes

​How to Increase the Odds for Success of Your 505(b)(2) Product
Course Duration: 60 Minutes​
​
​How to Ace an FDA Meeting
Course Duration: 60 Minutes
​
FDA Regulated Import and Export of Medical Devices 
​Course Duration: 60 Minutes

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

​Preclinical Testing for Drug and Biologics: Meeting FDA Requirements Without Breaking the Bank
​​​Course Duration: 60 Minutes
​
Patient Recruitment and Management in Clinical Trials Using Smart Phones
​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

​How to Use FDA’s Guidance Documents To Your Advantage
Course Duration: 90 Minutes​

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

​Managing Supplies in Your Clinical Trial: FDA Compliant Supply Chain Management​​​
​Course Duration: 60 Minutes​​

How to Train Yourselves to be a Good Technical Writer
​Course Duration: 60 Minutes​

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

Strategies for 510(k) Applications for Software or Software Containing Medical Devices​
Course Duration: 60 Minutes

​​Best Practices for Clinical Trial Risk Management: Common Issues and Potential Solutions​
Course Duration: 60 Minutes

​Good Tissue Practices and GMP for HCT/P and Stem Cell Therapies
​Course Duration: 60 Minutes
​
CMC Considerations for INDs and NDAs for 505(b)(2) Products
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

FDA is Changing GMP Audit Practices: Are You Ready?
​​Course Duration: 60 Minutes

​How to Find the Best CRO for Your Clinical Trial
​​Course Duration: 60 Minutes

Good Documentation Practices for FDA-Regulated Industry
​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

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