Medical Device Design Controls 101 – A Practical Crash Course

Teachers
David Amor
Category:
Introductory Courses/Med Device/On Demand Courses/Regulatory & Compliance/
Clear
Duration: 90 Minutes
On-demand
Includes handouts

Description

COURSE DESCRIPTION

OVERVIEW

Design control deficiencies continue to be in the top three FDA Warning Letter findings since 2007. Despite these findings over a long period of time, firms still fail to correct common design control failures.  As FDA becomes increasingly frustrated with the level of findings, they have made significant strides to crack down on lapses in design control protocols.  If you want to ensure your efforts stand up to any scrutiny, then join us for this comprehensive webinar.  By attending, you will learn about robust implementation of a design control process that is both compliant to 21 CFR 820.30 and practical!

LEARNING OBJECTIVES

Join our online training course where you will learn:

  • The importance of design planning – including quality planning
  • Design inputs and design outputs – from needs to requirements to specifications
  • Design Verification and Validation: learn how to build the right device and build it right
  • Integration of risk management into the design and development lifecycle
  • Integration of risk management per EN ISO 14971:2012
  • Integration of human factors and usability per EN ISO  62366-1:2015

Who Should Attend

WHO SHOULD ATTEND

This course will be of benefit to anyone involved in the design and development process for medical devices.  This includes project managers, engineers, executives leading new product initiatives, regulatory and quality specialists. as well as new product developers.

What To Expect

WHAT TO EXPECT

HOW TO PARTICIPATE

This webinar is offered on-demand. With your course purchase, you may view the previously recorded live session at your convenience (available for 30 days). Access to the on-demand webinar will be made available via email within 1 business day after your purchase. To access the course, you need only a computer with internet access and the log-in credentials.

THE TRAINING PLATFORM

Our webinar platform combines the convenience of online training with the live interactivity of the classroom. Quizzes, case studies, break-out sessions, and assessments are often incorporated into the training . Other ancillary materials can be downloaded from the “Handouts & Resources” area in the virtual classroom. Each course purchase includes a completion certificate issued to the participant after the course.

USER AGREEMENT

Your registration fee for a single participant entitles you to one telephone dial-in and one online course log-in per site. Course testing capabilities, stored results for training records, and completion certificates are available for only one registrant per single participant course purchase. For multiple participants, please purchase more than one registration or consider our 5 or 10 participant packages.

Is this course right for me? We’d be happy to help you select the right training course to meet your needs.
Give us a call at 215-675-1800 (9am – 5pm EST, M-F) for assistance.

About Instructors

David Amor
EU and US regulatory and quality management systems expert in design controls, risk management, combination products, and moible health.

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