Understanding Key Quality System Requirements for Combination Product (Medical device and Pharmaceuticals) Manufacturers

Why Should You Attend:

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 Webinar:

• 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 Will Benefit:

• R&D Engineers
• Quality and Manufacturing Engineers
• Regulatory Professionals
• QC/QA Personnel
• Combination Device Manufacturers

Meena Chettiar
Principal Quality Engineer, Freudenberg Medical

Meena Chettiar is currently working as a Principal Product Development Quality engineer at Freudenberg Medical in Minnesota, USA. Meena has worked in several capacities over the past 20 years in several high level Quality and Regulatory Management positions at pharmaceutical and medical device companies such as ProMed Pharma, Covidien, Teva Pharmaceuticals and NAMSA. She has also worked as QC lab supervisor at Land O’ Lakes in Minnesota and for Agriculture and Health Canada in several technical capacities for about 10 years.

Meena has participated as the lead supplier/internal/GMP auditor in several compliance audits in the US, India, Costa Rica, Mexico and Puerto Rico. She is a senior member of ASQ (American Society for Quality) and is ASQ certified CQA (Certified Quality Auditor), CBA (Certified Biomedical Auditor), CQIA (Certified Quality Improvement Associate), and CMQ/OE (Certified Manager of Quality/Organizational Excellence).She has served as an instructor for these ASQ certification classes since 2006. She is a certified instructor for ASQ learning institute for CBA and has been an adjunct instructor for Medical Technology Quality graduate program for St. Cloud State University in Minnesota since 2013. She is a coauthor of the CBA (Certified Biomedical Auditor) Primer for the Quality Council of Indiana.

Ms. Chettiar received her M.S. in Regulatory Affairs for Medical Devices in Minnesota, Chemical engineering from University of British Columbia in Canada and her B.S. and M.S in Applied Chemistry from the University of Madras, India.

Follow us :