Webinar on Major Considerations for Expanding your Quality System requirements (QSR) from Medical Devices to Combination Devices
October 24, 2014 - Mississauga ON CACompliance Trainings
uttam@compliancetrainings.com
Phone:4169154458
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, types and benefits How medical device manufacturers can have a competitive advantage, with established QSR Implementing Quality System Regulation 21 CFR Part 820/ISO 13485 Vs 21 CFR Part 210/211 & 21 CFR Part 4 for Devices, effective July 2013 FDA’s Final rule for clarification of cGMP requirements for combination products and its implications How to apply the right requirements to remain compliant Why and how to sufficiently anticipate and address the quality and regulatory challenges Considerations while expanding your QSR from Medical Devices to Combination Devices Role of Primary Mode of Action (PMOS) Implementation of Unique Pharma Provisions of 21 CFR 211 How to manage Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs) Submission Requirements for approval and clearance Post market vigilance differences How to sustain the growth to your Quality System in the long run Who Will Benefit: A must attend webinar for all Managers, Supervisors, Directors, and Vice-Presidents of: Quality Management Teams Reasearch & Development Teams Design Engineering Teams Quality Assurance Manufacturing Engineering Teams Operations Team Document Control and Regulatory Departments Regulatory Professionals in Pharma and Medical Device manufacturing and marketing Price Tags: Live Single Live : For One Participant $ 249 Corporate Live : For Max. 10 Participants $ 899 Recording Single REC : For One Participant - Unlimited Access for 6 Months $ 299