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HomeManufacturing (GMP)Design Controls 101: Beyond Regulatory Requirements

Design Controls 101: Beyond Regulatory Requirements

Teachers
Michael Drues
Category:
Introductory Pharma Courses/ Manufacturing (GMP)/ Medical Device Training/ On-Demand Courses/ Regulatory & Compliance/
Clear
Duration: 90 minutes
On-demand
Includes handouts
  • Description
  • Who Should Attend
  • What To Expect

Description

COURSE DESCRIPTION

OVERVIEW

Since 1990, FDA has required medical device manufacturers to follow design controls. Outside the US, the Medical Devices Directive (MDD) lists similar requirements as part of their quality system regulations.  Although medical device manufacturers must have design control systems in place, they are not always effective.

Inadequate design control procedures are commonly cited in warning letters, CAPA’s and product recalls.  An average of 44% of quality problems resulting in recall actions are attributed to deficiencies that may have been prevented by adequate design controls, and around 30% of warning letters listed inadequate design controls procedures in recent years. Clearly, having design controls in place is not enough.

In addition, because design controls must apply to a wide variety of devices, they do not specify what manufacturers must do to meet these requirements.  Instead, they establish a framework that provides manufacturers with the flexibility needed to develop design controls that both comply with the regulation and are most appropriate for their own design and development processes.

LEARNING OBJECTIVES

This 90-minute course will allow you to:

  1. Learn how design controls apply to both design and manufacturing
  2. Appreciate design verification and validation and the importance of each
  3. Hear how to properly modify a design or a process without causing problems later
  4. Determine how to properly conduct a design review
  5. Learn to integrate design control, risk management, and CAPA into an overall system
  6. Identify the keys to success in design transfer to manufacturing
  7. Understand what FDA looks for in a design control system

Learn to think beyond what the regulation says and apply best practices to avoid the most common design control problems.

Who Should Attend

WHO SHOULD ATTEND

This webinar is designed for R&D and product development engineers and managers, medical device developers and engineering managers, manufacturing engineers and technicians, and regulatory affairs professionals. Scientific and quality personnel responsible for implementing and/or following design control processes and anyone who would like to gain a better understanding of design control requirements will benefit from this course.

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

Michael Drues
Works regularly for the FDA, Health Canada, the US and European Patent Offices, and other regulatory and governmental agencies worldwide.

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Clear
Duration: 90 minutes
On-demand
Includes handouts

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