This webinar will explain the quality system regulations (QSR) for combination device manufacturers to ensure compliance with for FDA and ISO 13485 requirements. It will also provide practical tips to sustain the growth of your quality system in the long run.
Differences in regulatory requirements between medical devices and pharmaceutical products poses unique challenges to companies that want to manufacture devices that contain drugs and biological products (aka Combination Devices). Large and small medical device companies who want to embark into this new journey by adding a coating of a slow eluting drug product to their medical devices face challenges that range from facility design, changes in testing requirements to evaluation of major considerations in navigating their regulatory path to fulfilling the quality system requirements (QSR) in the ever changing, fast growing, complex arena of medical devices and pharmaceutical GMP considerations under one QSR umbrella.
This webinar presents important facts to simplify the planning and execution phase in your journey towards becoming a combination device manufacturer by incorporating the essential quality system requirements in your company. The experience shared at this webinar is based on experience and proven practices and hence several practical tips will be useful even to established combination device manufacturers.
Areas Covered in the Session :
- Brief introduction to 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.
- 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.
- 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.
- 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.
- Applying the right requirements to remain compliant in this fast growing landscape.
- 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?
- Understanding the role of primary mode of action (PMOS) to fulfil the EU and US quality and regulatory requirements.
- Implementation of unique pharma provisions of 21 CFR 211 such as expiration dating, stability testing and unique device labelling requirements such as UDI.
- 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 Assurance Departments
- Quality Control Departments
- Research and Development Departments
- Regulatory Affairs Departments
- Manufacturing Departments
- Engineering Departments
- Combination Product Manufacturers