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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.
Areas Covered in the Session:
- 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:
R&D personnel and management
Process and Quality Engineers
QA management
Consultants
Quality system auditors
About Speaker
Jeff Kasoff, RAC, is the Director of Quality at Byrne Medical, a leading manufacturer of endoscopy products. In this position, Jeff is responsible for supplier management, during which he oversees supplier management, CAPA, and document control. Prior to this, Jeff spent 13 years at Life-Tech as the Director of Regulatory Affairs, where he was responsible for regulatory compliance of all aspects of the quality system. Jeff received his regulatory affairs certification in 1996.
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