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 [...]
Regulatory Requirements for Software Validation – March 19-21, 2018 in Arlington, VA
This 3-day course focuses on the requirements contained in the Quality System regulation specific to software validation. The course explores the latitude and flexibility of the FDA's expectations and provides conceptual ways to meet compliance [...]
Webinar: Writing Human Factors Plans and Reports – March 15, 2018
As a medical technology developer who seeks to apply human factors engineering (HFE) effectively to produce safe and effective devices and to satisfy regulators' requirements and expectations, you may be frustrated that pre-existing guidance only [...]