Overview: 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.
Why you should attend: Because design controls must apply to a wide variety of devices, the regulation does not prescribe the practices that must be used. You need to be aware of how design control applies to your device(s). It's apparent many firms are not: inadequacy of the design control system was cited on almost half of the Warning Letters issued in 2009. If the FDA inspector believes your design control system is deficient, it will raise a white flag in his/her mind that perhaps this deficiency extends to other systems as well.
Areas Covered In the Seminar:
* 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
Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00
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.
Why you should attend: Because design controls must apply to a wide variety of devices, the regulation does not prescribe the practices that must be used. You need to be aware of how design control applies to your device(s). It's apparent many firms are not: inadequacy of the design control system was cited on almost half of the Warning Letters issued in 2009. If the FDA inspector believes your design control system is deficient, it will raise a white flag in his/her mind that perhaps this deficiency extends to other systems as well.
Areas Covered In the Seminar:
* 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
Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00
