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UID:2140535:Event:64740
DTSTAMP:20260523T175833Z
SUMMARY:Webinar on Major Considerations for Expanding your Quality Sys
 tem requirements (QSR) from Medical Devices to Combination Devices
DESCRIPTION:Differences in regulatory requirements between Medical Dev
 ices and Pharmaceutical products poses unique challenges to companies 
 that want to manufacture devices that contain drugs and biological pro
 ducts (aka Combination Devices). Large and small medical device compan
 ies who want to embark into this new journey by adding a coating of a 
 slow eluting drug product to their medical devices face challenges tha
 t range from facility design, changes in testing requirements to evalu
 ation of major considerations in navigating their regulatory path to f
 ulfilling the quality system requirements (QSR) in the ever changing, 
 fast growing, complex arena of medical devices and pharmaceutical GMP 
 considerations under one QSR umbrella.\n\nThis webinar presents import
 ant facts to simplify the planning and execution phase in your journey
  towards becoming a combination device manufacturer by incorporating t
 he essential quality system requirements in your company. The experien
 ce shared at this webinar is based on experience and proven practices 
 and hence several practical tips will be useful even to established co
 mbination device manufacturers.\n\nAreas Covered in the Session :\nBri
 ef introduction to common combination devices, types and benefits\nHow
  medical device manufacturers can have a competitive advantage, with e
 stablished QSR\nImplementing Quality System Regulation\n21 CFR Part 82
 0/ISO 13485 Vs 21 CFR Part 210/211 & 21 CFR Part 4 for Devices, effect
 ive July 2013\nFDA’s Final rule for clarification of cGMP requiremen
 ts for combination products and its implications\nHow to apply the rig
 ht requirements to remain compliant\nWhy and how to sufficiently antic
 ipate and address the quality and regulatory challenges\nConsideration
 s while expanding your QSR from Medical Devices to Combination Devices
 \nRole of Primary Mode of Action (PMOS)\nImplementation of Unique Phar
 ma Provisions of 21 CFR 211\nHow to manage Critical Quality Attributes
  (CQAs) and Critical Process Parameters (CPPs)\nSubmission Requirement
 s for approval and clearance\nPost market vigilance differences\nHow t
 o sustain the growth to your Quality System in the long run\n\nWho Wil
 l Benefit:\nA must attend webinar for all Managers, Supervisors, Direc
 tors, and Vice-Presidents of:\nQuality Management Teams\nReasearch & D
 evelopment Teams\nDesign Engineering Teams\nQuality Assurance\nManufac
 turing Engineering Teams\nOperations Team\nDocument Control and Regula
 tory Departments\nRegulatory Professionals in Pharma and Medical Devic
 e manufacturing and marketing\n\nPrice Tags:\nLive\nSingle Live : For 
 One Participant\n$ 249\nCorporate Live : For Max. 10 Participants\n$ 8
 99\nRecording\nSingle REC : For One Participant - Unlimited Access for
  6 Months\n$ 299\n\nFor more information and enquiries contact us at\n
 Compliance Trainings\n5939 Candlebrook Ct, Mississauga, ON L5V 2V5, 
 Canada  Customer Support : #416-915-4458  Email : support@complianc
 etrainings.com\nFor more information about this event please visit\nht
 tps://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1
 092\n\nFor more information visit https://medtechiq.ning.com/events/we
 binar-on-major-considerations-for-expanding-your-quality-system
DTSTART;TZID=America/New_York:20141024T130000
DTEND;TZID=America/New_York:20141024T140000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:https://compliancetrainings.com/SiteEngine/ProductDetailView.a
 spx?id=MD1092
URL:https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?
 id=MD1092
CONTACT:4169154458
ORGANIZER;CN=compliancetrainings:https://medtechiq.ning.com/profile/co
 mpliancetrainings
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ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=complianc
 etrainings:https://medtechiq.ning.com/profile/compliancetrainings
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