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 [...]
Webinar: Test Method Validation for Quality Systems – April 4 – May 16
These webinars will provide a working knowledge of Test Method Validation (TMV), also known as Measurement System Analysis (MSA) and Gauge R&R (GR&R). Concepts covered are also applicable to Analytical Procedures. The names are not [...]