Compliance Key - Compliance Online Training Webinars, Regulatory, Medical Device, FDA, Financia

Compliance Key INC  -  Medical Device Training Overview Design Controls are the processes used to design, develop, and manage medical devices that you manufacture. They are mandated by federal regulation, however, the regulations concerning design controls are vague in terms of the specific process steps required and the approaches that should be taken to achieve compliance should be developed. Knowing how the FDA both views and examines design controls is crucial to achieving compliance throughout the life of the medical devices you manufacture and is one of the most valuable compliance subject areas to explore. Noncompliance in design controls, which are consistently uncovered by the FDA during inspections and examinations, are concerned with the design control process that has been designed and applied and the documentation required to support each design control step. The specific sections of the regulations that apply to design controls include CFR 21 Part 820 Qua...

Compliance Key INC  -  Healthcare Compliance Webinars Overview The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different generic types of devices and grouped them into 16 medical specialties referred to as panels. Each of these generic types of devices is assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device.The determination process, how you apply the classification process to your device, is complex and requires several levels of analysis to make the proper device classification. Proper medical device classification is the fundamental first step in submitting your device for approval anywhere in the world. This webinar will detail the medical device classification process for the United States through the FDA and will overview the very complex process for medical device classification within the EU. Specifically, this webinar will provid...

Compliance Key INC  -  Medical Device training                                                       Charles Paul Charles H. Paul is Keynote Speaker at Compliance key Inc. He is President of C. H. Paul Consulting, Inc. - a regulatory, training, and technical documentation consulting firm. Charles is a management consultant, instructional designer and regulatory consultant and has led C. H. Paul Consulting, Inc.   Webinar Id:   LSHCCP008  12:30 PM PT | 03.30 PM ET   01/12/2018  Duration: 60 mins  Overview Design Controls are the processes used to design, develop, and manage medical devices that you manufacture. They are mandated by federal regulation however the regulations concerning design controls are vague in terms of the specific process steps required and th...