Description :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 proven successful practices and hence practical tips that will be useful to employees of established and emerging combination device manufacturers will be presented to you.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.Current Guidance Documents.Why a one size fits all approach to QSR just will not work for combination devices?Quality System Regulation, 21 CFR Part 820/ ISO 13485 Vs 21 CFR Part 210/21, 21 CFR Part 4Guidance for Industry and FDA staff on GMP Requirements for Combination products released in January 2015Unique challenges and an insight into how you can overcome themImplications of FDA’s Final rule for clarification of cGMP requirements for combination productsWhy and how can medical device manufacturers broaden their in house and consulting expertiseHow 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 DevicesRole of primary mode of action (PMOS) of your device and submit paper work to the respective EU and US FDA regulatory body.Implementation of unique pharma provisions of 21 CFR 211 such asExpiration datingOut of specificationStability testingUDI Labelling RequirementsMDR for complaintsSterilizationClean room environmentManaging critical quality attributes (CQAs) and critical process parameters (CPPs), clinical studies, submission requirements for approval and clearance and post market vigilance differences.Who Will Benefit:A must attend webinar for Managers, Supervisors, Leads, Specialists, Engineers and Groups in Department of:Research & DevelopmentManufacturing and Process EngineeringDesign AssuranceQuality AssuranceQuality ControlDesign EngineeringOperationsDocument ControlRegulatory AffairsPrice tags:LiveSingle Live : For One Participant$ 249Corporate Live : For Max. 10 Participants$ 899RecordingSingle REC : For One Participant - Unlimited Access for 6 Months$ 299For more information and enquiries contact us atCompliance Trainings5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada  Customer Support : #416-915-4458