This intensive 3 day course provides complete coverage of design control requirements for FDA Quality System Regulation, ANSI/AAMI/ISO 13485:2016, and the Medical Device Single Audit Program (MDSAP). With the participation of FDA representatives during the entire course, attendees have the unique opportunity to participate in a shared learning experience.
An optional exam is available online for 2 weeks following the end of the program.
Instruction is targeted to professionals involved in meeting design control requirements such as those in regulatory affairs, quality assurance, design engineering, manufacturing, operations, and members of research and development or new product development teams.
• Be competent and confident to handle FDA audits on design controls
• Correctly Interpret the FDA regulations that apply to Design Controls
• Be able to evaluate the degree of compliance of a design control system, including identification of noncompliance issues
• Be able to Implement improvements to meet regulatory and business strategies.