Our workshops offer detailed in-person training on a given topic in a classroom or boot-camp setting, conducted by renowned experts in the field. The workshops include 14-16 hrs of training, complete training material, lunch, energy breaks, and networking opportunities with the trainer and other attendees. Our current offerings in 2018 include the following workshops; please click below for detailed agenda, locations, speaker and other specifics. Please check frequently for updates.
eCTD Submissions of IND and NDA/BLA to the US FDA: Hands-on Workshop
February 28, 2020
Workshop: Writing Technical Regulatory Documents
March 26-27, 2020
Practical tips and training in writing good quality regulatory documents for submission to FDA and other regulatory agencies.
How to Keep Your Operations Working in a Pandemic: Crisis Management for the FDA-Regulated Industry
April 15, 2020
Clinical Project Management Training
May 5, 2020
510(k) Submissions to the FDA: Hands-On Workshop
April 23-24, 2020
FDA Compliant SOPs for Regulated Industry: Documents of Ideal Quality Management Systems
July 23-24, 2020
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
Best Practices for Safety Reporting in Clinical Trials for Drugs, Biologics and Medical Devices - Coming Soon
Best Practices for Medical Device Auditing - Coming Soon
Workshop: Import and Export of Medical Devices - Coming Soon