Seminar – Latin America: Regulatory Compliance Requirements for Life Science Products (Focus: Brazil, Mexico, Argentina) – New Orleans, LA – May 2-3, 2019
This two-day comprehensive Course on Latin America Regulatory compliance requirements will cover topics ranging from pre-clinical and clinical requirements through product registration, amendments and renewals across Pharmaceuticals, Biologics, Medical Devices and Combination Products. The Course [...]
Process Validation Requirements and Industry Practice Course – April 16-18, 2019 in Arlington, VA
This 2.5-day course provides attendees with practical tools and techniques for process validation requirements for FDA’s Quality System regulation and recognized Process Validation Guidance from the Global Harmonization Task Force. The program includes industry best [...]
The Quality System Regulation 21 CFR 820 ANSI/AAMI/ISO 13485: Navigating Requirements – April 8-12, 2019
For registration info: https://www.aami.org/events/eventdetail.aspx?ItemNumber=7186
Regulatory Education for Industry (REdI): Generic Drug Forum – April 3 & 4, 2019
This event offers practical advice, case studies, and a deep dive into the Abbreviated New Drug Application (ANDA) assessment process. FDA will also discuss science unique to generic drug applications. After this course, attendees will [...]