This webinar will enable you to understand the classes of recalls and their relationship to deficiencies in the design and development process, how to develop a strategy for preventing recalls right from the beginning of the process and how the application of risk analysis is a valuable tool in identifying potential areas that could cause recalls.
The secret to preventing medical device recalls is to implement and follow basic practices for specifications and design control, design for process reliability, production validation and design validation using accelerated life tests.
This webinar is about controlling safety risk from specification writing to device retirement – control throughout the product’s life cycle.
The webinar will provide an overview and a foundation for further learning concerning preventing recalls during specification writing, risk assessment and risk management, preventing recalls during the early design and the detail design phases of development, and preventing recalls during validation, verification, and software design.
Areas Covered in the Session :
- Explain the key techniques for avoiding medical device recalls during each phase of the medical device development process to include:
- Specification writing
- During the early design phase
- During the detail design phase
- When designing for prognostics to protect patients
- During production validation
- During software design
- When structuring the supply chain and establishing supply chain quality requirements
- How the effective application of the verification process can contribute to preventing device recalls
- Role that design validation plays in preventing medical device recalls
- Role of management in preventing medical device recalls
- Innovative methods useful in preventing recalls
Who Should Attend:
- Device manufacturers
- R&D Departments
- Quality Departments
- Compliance Departments
- Regulatory Affairs Departments
- Engineering Departments
Course Director: CHARLES H. PAUL
Charles Paul is an instructional designer and management consultant with over 30 years experience providing training and consulting services to regulated industries. He has installed quality systems and designed and developed GMP and operational documentation and training programs for foods and beverage, pharmaceuticals, biotech, cosmetics, and consumer product OTC industries.