Our workshops offer detailed in-person and virtual training conducted by renowned experts in the field. The workshops include 8 to 14 hours of training and complete training materials. Our current offerings in 2023 include the following workshops; please click below for detailed agenda, speaker and other specifics. Please check frequently for updates.
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​Workshop: Writing Technical Regulatory Documents
March 23-24, 2023
Practical tips and training in writing good quality regulatory documents for submission to FDA and other regulatory agencies.

eCTD Submissions of IND and NDA/BLA to the US FDA: Hands-on Workshop
April 12, 2023

510(k) Submissions to the FDA: Hands-On Workshop
​​May 11-12, 2023

FDA Compliant SOPs for Regulated Industry: Documents of Ideal Quality Management Systems 
​​May 18-19, 2023

Clinical Project Management Training
​​May 25, 2023

FDA’s GMP Expectations for Phase I and First-in-Man Clinical Trials 
​​​July 20-21, 2023

How to Keep Your Operations Working in a Pandemic: Crisis Management for the FDA-Regulated Industry
Dates to be announced soon

Workshop: How do I Meet FDA and Get the Most Out of My FDA Meeting  
Dates to be announced soon                                                              
This two day seminar will provide valuable tips about the logistics, planning, conduct and best practices for all kinds of meetings with the FDA. ​

The Latest CMS Guidelines for Food Sanitary Conditions - Coming Soon 
Washington DC                                               

Best Practices for Safety Reporting in Clinical Trials for Drugs, Biologics and Medical Devices  -  Coming Soon
Washington DC                                             

Best Practices for Medical Device Auditing - Coming Soon
Washington DC                                             

+1 410-501-5777
+1 877-566-4981

Workshop: Import and Export of Medical Devices - Coming Soon 
Washington DC