Medical device design control

Don’t have a problem and enroll to attend the interactive workshop Medical Device Design Control: Implementing an Approach That Works in Chicago on June 16-17, 2015.

You'll have the opportunity to gain a greater understanding of the issues confronting you from Dan O’Leary, an expert in quality, operations and program management … as well as benefit of hearing from and discussing the issues with attendees who face the same challenges you face every day.

With O’Leary taking the lead, you'll learn requirements, develop approaches, and find out how to execute them through a series of exercises prepared especially to simulate real-life scenarios.

Using examples and case studies, you will deepen your understanding of design controls and find out how to develop procedures that accurately define and document your approach.

Since many device manufacturers market in the U.S., the EU, and Canada, you'll learn the similarities and differences in the requirements of the three regions, so you can develop a fully comprehensive system that includes them all.

And to enhance your understanding, many presentations will feature recent Warning Letters to illustrate potential problems – and help you learn from the mistakes of others.

Attend this interactive workshop and you will learn:

• The regulatory basis for design controls in the U.S., the European Union, and Canada
• Methods of design planning based on project management techniques
• Developing sources of design input and resolving problems
• The role of design output and methods to ensure it is complete
• How to conduct design reviews that help improve the device design
• Using design verification methods to match design output with design input
• Conducting design validation and its critical elements of software validation and risk management
• Implementing the 5 vital components of design change

You'll also participate in these comprehensive exercises:

Identify total design control requirement
Review of specific design control requirements, determine their source and identify implementation methods

Developing a project plan
Analysis of a small example project, identify stages and develop a Work Breakdown structure (WBS) and a Gantt chart for the project

Developing and resolving input requirements
Develop a set of design inputs for an example product and use the results to identify missing, incomplete or ambiguous requirements.

Design output completeness
Review design outputs for an example product and identify essential requirements, acceptance criteria, and gaps in the requirements

Identifying and resolving problems
Design reviews systematically, and examine a design to evaluate its adequacy and capability with the intent to identify problems. Participants critique a design review to determine if it is sufficient.

Design verification methods
Examine paired design inputs and design outputs and determine the best tool for design verification. In some cases the analysis is extended to look specific aspects of the tools.

Examining a design validation plan
Critique a design validation that starts with user needs and intended uses. The plan uses production equivalents and simulated use conditions.

Determining when a process must be validated
Some production processes require process validation, while others do not. You'll determine analyze processes transferred to production and document whether they require process validation.

Classify changes as a design change or a production process change
QSIT informs the FDA Investigator that Production and Process Changes could be Design Changes. This exercise gives attendees an opportunity to classify changes and provides insight into the decisions to make in the QMS.

Register Today

Review the entire Workshop agenda

Source: FDA