CDER Small Business & Industry Assistance (SBIA) Spring Conference – May 15 & 16, 2018
The Regulatory Education for Industry (REdI) Conference is an FDA-led forum that brings together the regulatory educators from FDA’s CDER and CDRH. The goal of this conference is to provide direct, relevant, and helpful information [...]
Webinar: Consolidating Human Factors and User Interface Design Validation Efforts – May 2, 2018
When contemplating the difference between human factors (HF) validation and design validation, the Venn Diagram is your friend. The two types of validation efforts almost always overlap. However, HF validation is not necessarily a simple [...]
Process Validation Requirements and Industry Practice – April 18-20, 2018 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 and ANSI/AAMI/ISO 13485: Navigating Regulatory Requirements – April 16 – 20, 2018 in Arlington, VA
The regulatory world for quality management systems (QMS) is changing fast. To succeed in today's global market, the manufacturers of medical devices must understand those requirements. This intensive 4 ½ day course provides quality system [...]