When: |
29 Mar through 29 Mar 2017 | |
Where: |
Online Event | United States | |
Website URL: |
https://www.atozcompliance.com/trainings-webinar/life-sciences/medical-devices/understanding-design-controls/charles-h-paul/300167?utm_source=ref&utm_medium=29Mar | |
Sponsoring organization: |
AtoZ Compliance | |
Categories: |
Medicine & Health - Medical-Speciality |
Keywords:
Event description:
The design control plan – its contents, functions, uses, life cycle process and the FDA guidance on adaptive design
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 regulatio...
Read more
Posting date:
23 February 2017 | 110 views
Placement:
Not-featured (How do I make my event featured?)
Flag (Report this event)