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.

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​

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

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

Development and Marketing of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps) in the US  
Course Duration: 60 Minutes

Patient Recruitment and Management in Clinical Trials Using Smart Phones
​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​

​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
​
FDA is Changing GMP Audit Practices: Are You Ready?
​​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
​
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 Make Efficient FDA-Compliant Clinical Protocol Amendments
​Course Duration: 60 Minutes

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

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

​How to Withstand an FDA Audit of Your Facility
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

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 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

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

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

FDA's Guidance on Process Validation for Drugs and Biologics - 3 Steps to Compliance
Course Duration: 60 Minutes
​
​New Rules for FDA Regulation for Lab Developed Diagnostic Tests(LDT)
​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