Design Control Training for Medical Devices: Requirements and Best Practices
Available as a virtual instructor-led seminar.
This Design Control course is US-focused. The participants will gain a fundamental understanding of how medical devices are regulated in the US: the main legal basis, FFDCA (21 U.S.C. 301) and the specific Medical Device Quality Systems Regulation, and the comparison/contrast of the GMP requirements imposed on the medical devices and pharmaceutical products in the US. In addition, the partipants will be introduced to a brief overview of relevant global regulatory framework including the EU MDR 2017 and the latest ISO standards (ISO 13485:2016).
Fortunately, Alan Golden Principal at Design Quality Consultants, LLC with over 30 years’ experience working in the medical device industry will focus on introducing the attendees to the regulatory requirements stipulated under the US Medical Device Quality Systems Regulation. Each of the seven key elements of Design Control compliance will be briefly reviewed. In addition, specific GMP requirements, submission dossier preparation throughout the Design Control lifecycle and submission strategy will be discussed.
Who Will Benefit
This course will be most valuable to Medical device industry engineers, engineering managers, regulatory affairs professionals, scientists, and quality engineers.
Personnel involved in product development, manufacturing, quality assurance, or regulatory affairs that do not have an in-depth knowledge of the Design Control, and its workings, will benefit from this course. Additionally, this program can be customized and delivered on-site for more experienced personnel (including middle and upper management) to update and broaden their knowledge of the FDA's Design Control requirements.
Agenda for the Seminar
- My background and experience
- Why design control
- Purpose of design control
- Benefits of design control
- Overview of design control
Scope and Responsibilities
- Devices requiring design control
- Scope and responsibility definitions
- Management responsibilities
Design and Development Planning
- When a plan is required
- Elements of a plan
- Project management
- Planning tools
- Change of plans
- Design input definitions and requirements
- When research ends and development begins
- Concept vs. design input
- Sources of design input
- Inadequate design input
- Types of design input
- Document controls
- Design output definitions and requirements
- Examples of design outputs and specifications
- Relationship between design output and the product’s Device Master Record (DMR
- Relationship of design reviews to design control
- Purpose of design reviews
- Quality system requirements of design reviews
- Design review board
- Number and types of design reviews
- Design review documentation
- Conducting design reviews
- Relationship of design input, design output and design verification
- Design verification definitions and requirements
- Verification activities
- Design validation documentation
- Trace matrix
- Design verification vs. design validation
- Design validation definitions
- Design validation requirements
- Design validation documentation
- Clinical trials vs. clinical evaluation
- Design validation and planning
Test Method, Process, and Software Validation
- Why validate test methods, manufacturing processes, or software?
- Relationship between test method, process and software validation to design control
- Relationship between process and test method validation
- When to validate test methods and processes
- Software validation
- Risk analysis requirements
- Risk analysis terms and definitions
- Risk management and activities
- Risk management tools
- Design Change requirements
- Application of design changes
- Change control objectives
- 5th interactive activity: Design change and change control
Design Transfer and Process Validation
- Design transfer requirements
- Changes during design transfer
- Relationship of design transfer and validation
- Process validation requirements
- Process validation definitions and requirements for:
- Product performance
Design History File
- Design History file definition and requirements
Final Comments and Questions
Upon completion of this course, participants will be able to:
- Describe the legal basis & industrial standards regulating the manufacture of medical devices.
- Gain an understanding of the regulatory framework for Design Control and recommendations to effectively meet the requirements of Design Control.
- Describe general regulatory requirements pertaining to design control within the quality system and regulation, design control procedures, safety/risk management, documentation, manufacturing transfer strategies, and strategies for integrating general quality system procedures into design control.
- Outline steps and tools to establish and implement effective design controls and quality management system.
Virtual Session Details
World Compliance Seminars is Virtual Instructor-Led Training (WCS) is a real-time internet-based learning experience where the instructor and learners are in separate locations. WCS technology platform is designed to simulate a traditional in-person classroom experience and allows for 2-way dialogue, break-out sessions for engaged workshops and hands-on exercises, and group work using virtual breakout rooms. This provides for an engaging learning experience in which participants can connect with the content and interact with both the instructor and other classmates.