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

​Avoid Data Integrity Issues: How to Audit a CRO and Other Vendors
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

​​Expedited Approval Pathways in the US: Best Ways to Get the Most Incentives​
Course Duration: 60 Minutes

How to write a good Clinical Study Report (CSR) for FDA submission
​Course Duration: 60 Minutes
​
​Investigating Out-of-Specification (OOS) Test Results in the Laboratory – FDA’s Expectations​
​Course Duration: 60 Minutes

Cleaning Validation for GMP Facilities
​Course Duration: 60 Minutes

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

Pragmatic Trials: Bridging Theory to Practice in Healthcare Research
Course Duration: 60 Minutes

​​CMC Considerations for INDs and NDAs for 505(b)(2) Products
Course Duration: 60 Minutes

HIPAA Training and Certification for Clinical Trial Professionals: What Applies, What Doesn't
​​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

Opioid Pain Management, FDA Regulations and Requirements for Good Clinical Practice
Course Duration: 90 Minutes

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

FDA Permitted Off-Label Promotion of Regulated Products
Course Duration: 60 Minutes

Strategies for 510(k) Applications for Software or Software Containing Medical Devices​
Course Duration: 60 Minutes
​
FDA Regulation of Molecular Diagnostics
​​​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

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

How to Make Efficient FDA-Compliant Clinical Protocol Amendments
​Course Duration: 60 Minutes

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

FDA Regulated Import and Export of Medical Devices 
​Course Duration: 60 Minutes​
​
How to Create Flow Charts for Your SOPs: Visual Tools for Increased Compliance
Course Duration: 60 Minutes

​FDA Rules for the Content, Tone and Format of an Investigator’s Brochure
Course Duration: 60 Minutes

​Drug Master Files – Helping with FDA DMFs
Course Duration: 60 Minutes​

Regulatory Strategies for Small and Medium Companies
Course Duration: 60 Minutes
​​
How to Train Yourselves to be a Good Technical Writer
​Course Duration: 60 Minutes​

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

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

How to “Win” FDA’s Support for Your Clinical Development Program
Course Duration: 60 Minutes​

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

​Five Best Practices for Using Email in FDA Regulated Industry
Course Duration: 60 Minutes
​
​How to Write Perfect FDA-Compliant SOPs: Stepwise Instructions
Course Duration: 60 Minutes​

​How to Make Sure Your Foreign Vendor is FDA Compliant and Stays That Way
​​​​Course Duration: 60 Minutes

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

Regulatory Issues with Developing Companion Diagnostics: FDA Policies and Expectations Clarified
​​​Course Duration: 60 Minutes

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

3D Printing for Manufacturing Regulated Products: FDA’s Current Acceptance and Future Projections
​​​Course Duration: 60 Minutes

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

​Best Practices for Clinical Trial Risk Management: Common Issues and Potential Solutions​
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

FDA Compliant Use of Smartphone, Smartwatch, and Apps in Clinical Trials 
Course Duration: 60 Minutes​

​FDA Compliant Vendor Validation Programs
Course Duration: 60 Minutes
​
Good Tissue Practices and GMP for HCT/P and Stem Cell Therapies
​Course Duration: 60 Minutes

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

​Managing Supplies in Your Clinical Trial: FDA Compliant Supply Chain Management​​​
​Course Duration: 60 Minutes​
​
​FDA IND Submission for a 505(b)(2) Product
​Course Duration: 60 Minutes

What Should Be in a Certificate of Analysis per FDA?
​​Course Duration: 60 Minutes
​
FDA Regulation of Dietary Supplement Imports into the US
​​​Course Duration: 60 Minutes​​​

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

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

Medical Foods: Practical Tips to Meet Latest FDA Requirements for Claims and Quality
​Course Duration: 60 Minutes​​​​​
​
​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