Design Controls Basics - From Design Inputs to Design Outputs and Effective Design Transfer

The emphasis on design controls arose from studies and evaluations that indicated that many device recalls and failures were due to ineffective and faulty designs. This sections details the requirements for up-front design and development planning, obtaining design inputs from end-users, translating the inputs into essential outputs, verifying and validating the design and effectively transferring the design to production. Design reviews must be conducted at appropriate intervals and all design activities should be documented in a Design History File. This Webinar will provide a overview of all the steps involved in design controls and explain and clarify and state specific requirements in the regulations.

Areas Covered in the seminar:

• Importance of Design Controls in FDA and ISO Quality Systems Regulations
• Effective design and development planning
• Obtaining design inputs and translating them to design outputs
• Distinguishing between design verification and validation
• Design reviews - process and requirements
• Design transfer - process and requirements
• Design Changes and change control
• Design History File and document control

Who Will Benefit:

This Webinar will provide an overview of the Design Controls for medical devices. It will describe the elements in design and development as required by the regulations and the importance of design controls in developing and producing consistent, safe and effective devices to the end-user.

• VPs of Marketing, Quality, Technology and Engineering
• New Product Development teams
• Design engineers
• Quality managers and engineers
• Marketing managers

Instructor Profile:

Dr. Vinny Sastri, President of WINOVIA® LLC, and has over 20 years experience in new product development and quality improvement with a strong track record in the healthcare, medical device, electronics and consumer goods industries. He is a certified Six Sigma blackbelt. Winovia LLC a consulting company that provides sustainable solutions new product development, quality improvement and high performance materials with the goal of strategic market penetration, improving efficiencies of products, processes and services, streamlining business processes, reducing operational costs, improving margins and increasing revenues and profits for its clients.

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