Design Controls – A Roadmap to Successful Implementation: One and a Half – day In-person Seminar
Course Description:
Design Controls are a key requirement in both the FDA’s Quality System Regulation and ISO 13485:2003. Yet fifteen years after the introduction, it is still an opportunity for improvement for many companies. In the 2011 report on Understanding Barriers to Medical Device Quality, FDA stated that an ineffective Design Controls program was the root cause for 31% of the recalls for the period 2003 -2009. In spite of the resources dedicated to this effort, many companies struggle with translating customer requirements into the “critical-to-quality” parameters needed to design and validate their products and next-generation models.
The upcoming training program is an interactive workshop that reviews the origins of design controls, the regulatory requirements, with a brief review of useful quality and project management tools. This program includes time for interactive case studies to help the participants learn how to create, sustain and improve the design control processes for their organization, and provides a current “state of the union” to help identify future opportunities and challenges.
Learning Objectives:
Key goals of the conference will include learning:
- Historical context that created the requirements for Design Controls for medical device manufacturers
- Basic concepts of approaches to Design Control and how to drive the development cycle
- The softer side of Design Controls – utilizing Project Management skills in a Regulated World – key document requirements and key differences
- The Regulatory Landscape: the requirements and expectations of 21 CFR 820.30 and ISO 13485:2003 and nuances to look for
- Interactive sessions/case studies for application of the elements
- Warning Letter examples of how “not” to do it
- The business reality of design changes and how to manage the information flow
- How the product clinical experience impacts the Design History File
- Risk Management considerations and FDA’s Total Life Cycle Approach
- Practical challenges on knowledge management – organizing for success and speed
- The changing regulatory landscape – current performance versus future expectations
