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 benefitsHow medical device manufacturers can have a competitive advantage, with established QSRImplementing Quality System Regulation21 CFR Part 820/ISO 13485 Vs 21 CFR Part 210/211 & 21 CFR Part 4 for Devices, effective July 2013FDA’s Final rule for clarification of cGMP requirements for combination products and its implicationsHow to apply the right requirements to remain compliantWhy and how to sufficiently anticipate and address the quality and regulatory challengesConsiderations while expanding your QSR from Medical Devices to Combination DevicesRole of Primary Mode of Action (PMOS)Implementation of Unique Pharma Provisions of 21 CFR 211How to manage Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs)Submission Requirements for approval and clearancePost market vigilance differencesHow to sustain the growth to your Quality System in the long runWho Will Benefit:A must attend webinar for all Managers, Supervisors, Directors, and Vice-Presidents of:Quality Management TeamsReasearch & Development TeamsDesign Engineering TeamsQuality AssuranceManufacturing Engineering TeamsOperations TeamDocument Control and Regulatory DepartmentsRegulatory Professionals in Pharma and Medical Device manufacturing and marketingPrice Tags:LiveSingle Live : For One Participant$ 249Corporate Live : For Max. 10 Participants$ 899RecordingSingle REC : For One Participant - Unlimited Access for 6 Months$ 299