How to Establish A Medical Device Quality System 2012

Key Topics

• Identify requirements under 21 CFR Part 820
• Review 21 CFR Part 820 and how to interpret
• Review 21 CFR Part 820, Subparts F-O and how to interpret
• Review 21 CFR Part 820, Subparts A-E and how to interpret
• Discuss how to meet the requirements identified

Who should Attend

• Regulatory affairs (associates, specialists, managers, directors and VPs)
• Senior and executive management (VPs, SVPs, Presidents and CEOs)
• Quality assurance, quality control, and quality systems (associates, specialists, engineers, managers, directors and VPs)
• Clinical affairs (associates, specialists, coordinators, managers, directors and VPs)
• Product and development (associates, scientists, managers, directors and VPs)
• Research and development (associates, scientists, managers, directors and VPs)
• Site managers, and consultants
• Marketing (associates, specialists, managers, directors and VPs)
• Contract research organization (associates, scientists, managers, directors and VPs)
• Contract manufacturing organization (associates, scientists, managers, directors and VPs)
• Contractors and subcontractors
• Senior and executive management (VPs, SVPs, Presidents and CEOs)