COURSE OUTLINE
The FDA Quality System Regulation, 21 CFR Part 820, ISO 13485:2016 and Medical Device Single Audit Program (MDSAP) contain significant requirements in relation to design and development (design control). In many cases manufacturers have not satisfactorily established compliance with the regulation and standard and have received adverse inspections, including issuance of FDA Warning Letters and Import Alerts. In practical terms, good design control results in timely, cost-effective design projects which deliver safe and effective medical device, and other healthcare products to the market place.
This 2 day special training program is intended as an introductory course to provide participants to have a basic understanding of design and development requirements (design control) and its benefits, design control from a regulatory perspective, phases of design control, elements of design control and their execution, to develop skills for preparation of design history file.
Who Should Attend
Management personnel and product manager who have responsibility for design control, Supervisors of various departments: Quality Assurance, Regulatory, Production, Engineering, and Internal Auditors should attend this seminar.
Seminar Materials
Seminar manual with workshop and guide for design control.
Seminar Goals
• Obtain the most up-to-date information in relation to design and development control requirements as defined in the FDA’s CFR 820.30, ISO 13485:2016 and MDSAP
• Understand the use of risk management in the design control process
• Understand the differences between design verification and design validation
• Understand the concept of design change control
• Understand what a design history file should contain
Seminar Outline
I. Design Control, the regulatory imperatives, QSR, ISO 13485:2016 and MDSAP
II. Risk analysis in relation to design control
III. Elements of design control (with interactive exercises) including:
• Identification of user requirements
• Design inputs
• Design outputs
• Design review
• Design verification
• Design change control
• Design transfer
• Design history file