This webinar will provide an overview of design controls for medical devices. It will cover the basics of design controls and how they ensure all requirements are met while not creating barriers to timely market introduction. The webinar will discuss design control requirements at each stage of the design process, including planning, input/output, reviews, documentation, and transfer. It will also cover post-market design control requirements. The speaker is an expert in quality and regulatory compliance for medical devices.

1. Live Webinar on : Understanding Design Controls for Medical Devices Wednesday, March
28, 2012 duration : 01:00 to 02:00 PM EST
Description
Prior to introduction of a new device, or even a
modified design for an existing device, a systematic
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process must be followed. This process must ensure
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that all requirements are met. A firm's design control
CGO15
process must meet all regulatory requirements, but at
the same time not be so unwieldy as the present a
Who will benefit barrier to timely market introduction. This webinar
will cover the basics of design controls, and provide
recommendations for implementation of a compliant
· This webinar will provide design control system. Also discussed will be design
control requirements for devices already in
valuable assistance to all
distribution. Documentation requirements for each
companies that perform design design stage will be included as well.
activities. The employees who will
benefit include:
R&D personnel and management Areas Covered in the Session
Process and Quality Engineers - History of design control
QA management - Design planning
Consultants - Design input/output
Quality system auditors - Design reviews
- Design documentation
- Design transfer

2. - In-process design control
purchase formats About Speaker:
$189 One Dial In - One Jeff Kasoff, RAC, is the Director of Quality at
Attendee Byrne Medical, a leading manufacturer of
endoscopy products. In this position, Jeff is
$249 One Dial In - Unlimited responsible for supplier management, during
attendance (To be arranged in a which he oversees supplier management, CAPA,
Conference room/Meeting room. and document control. Prior to this, Jeff spent 13
Note : Only One Dial In Allowed) 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
$289 On Demand (Recording received his regulatory affairs certification in 1996.
available within 48 hrs after the
completion of the webinar)
$349 Get Training CD
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