Quality System Regulations for Combination Products 2019

Topics

• Why a one size fits all approach to QSR just will not work for combination devices which may help provide a competitive advantage to medical device manufacturers with established QSR
• Common combination devices, why combination devices to advance patient care and provide competitive market advantage? Types of combination products and which QSR applies to which combination/primary mode of action
• Implications of FDA’s Final rule for clarification of cGMP requirements for combination products which contain two or more highly regulated entities to enhance safety and/or effectiveness of either product used alone
• Quality System Regulation, 21 CFR Part 820/ ISO 13485 Vs 21 CFR Part 210/211 and 21 CFR Part 4 for these Devices, effective July 2013
• Why and how can medical device manufacturers broaden their in house and consulting expertise to sufficiently anticipate and address the challenges in quality and regulatory issues that must be considered while expanding your Quality System requirements (QSR) from Medical Devices to Combination Devices?
• Applying the right requirements to remain compliant in this fast growing landscape
• Implementation of unique pharma provisions of 21 CFR 211 such as expiration dating, stability testing and unique device labelling requirements such as UDI
• The role of primary mode of action (PMOS) to fulfil the EU and US quality and regulatory requirements
• Managing critical quality attributes (CQAs) and critical process parameters (CPPs), submission requirements for approval and clearance and post market vigilance differences

Who should Attend

• Quality Control Departments
• Quality Assurance Departments
• Regulatory Affairs Departments
• Research and Development Departments
• Engineering Departments
• Manufacturing Departments
• Combination Product Manufacturers