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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FDA Compliant SOPs for Regulated Industry: Documents of Ideal Quality Management Systems
May 18-19, 2023 Workshop: Writing Technical Regulatory Documents
October 5-6, 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
November 14, 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
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