Live Webinar Design Control Principles for Medical Device Manufacturers
01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute
Webinar Includes : All the training handouts , Certificate by the Speaker ,Q/A and 60 Min Live Webinar
"Hear By Jeff Kasoff, RAC, CMQ/OE has more than 30 years in Quality and Regulatory management"
Prior to introduction of a new device, or even a modified design for an existing device, a systematic process must be followed
Prior to introduction of a new device, or even a modified design for an existing device, a systematic process must be followed. This process must ensure that all requirements are met. A firm's design control process must meet all regulatory requirements, but at the same time not be so unwieldy as the present a barrier to timely market introduction. This webinar will cover the basics of design controls, and provide recommendations for implementation of a compliant design control system. Also discussed will be design control requirements for devices already in distribution. Documentation requirements for each design stage will be included as well.
• History of design control
• Design planning
• Design input/output
• Design reviews
• Design documentation
• Design transfer
• In-process design control
Who will Benefit
This webinar will provide valuable assistance to all companies that perform design activities. The employees who will benefit include:
- Development Engineers
- R&D support personnel
- R&D management
- Manufacturing Engineers
- Quality Engineers
- QA management
- Internal auditors
Industries who can attend
This 60-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.