Integrating the requirements of 21 CFR 820 into a product development process is challenging. Done poorly, it drags down the design process and puts you at risk. Done well, it delivers quality products, resource efficiencies and compliance that are easily demonstrated to the FDA.
You can’t afford to be in a position where either design controls or the product development process are weak. Design controls are essential to safety and effectiveness. The FDA reports ineffective design controls are the root cause of as many as 31% of recalls. Ineffective product development processes are slow, costly and often miss significant business objectives.
This seminar on quality system regulations for medical devices will show you how to build a best practice stage gate product development process that not just incorporates 21 CFR 820 design controls but keeps you ahead of the competition and easily shows compliance during an audit. The process showcased in this course will also fulfill QSR requirements, produce the objective evidence necessary to prove compliance, manage resources and deliver quality products.
The seminar will focus on understanding:
- The key elements of 21 CFR 820 design controls
- Best practice stage gate product development
- How 21 CFR 820 design controls can be integrated into a stage gate product development process
- How to link to intended use, user needs, risk management and manufacturing processes
- How to manage both new product development and design changes
- How to manage marketing, costs and schedule requirements in parallel with the regulatory processes
- How to systematically create the required objective evidence and how to easily produce it during an audit
Who will Benefit:
- Project managers
- Quality managers and staff
- R & D, product development and sustaining engineering, managers and staff
- Design transfer managers and staff
- Regulatory and compliance managers and staff
- Compliance and product development consultants
- Anyone with product development, risk management, regulator or quality assurance responsibilities