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DTSTART:19700308T020000
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UID:2140535:Event:68511
DTSTAMP:20260519T143534Z
SUMMARY:Webinar on Implementing Adequate CAPA and Design Control Proce
 dures
DESCRIPTION:Description :\nDevice firms, who are intending to bring me
 dical device products into the US market, are subject to quality syste
 m regulations.\nRecent FDA enforcement trends (including 2013) reveal 
 that both design control and Corrective and Preventive Action (CAPA) s
 ystems are critical elements to sustain FDA inspections.\nDevice manuf
 acturers are required to establish and maintain FDA-compliant quality 
 management systems, where appropriate and applicable, including design
  control and CAPA systems. This webinar is intended to provide guidanc
 e on understanding, interpreting, and implementing design control and 
 CAPA system requirements.  This presentation is further intended to h
 elp you establish and maintain adequate design control and CAPA proced
 ures for all classes of medical devices including IVDs.\nUnderstanding
 , interpreting, and implementing design control and CAPA system requir
 ements in a holistic manner can significantly contribute to your produ
 ct quality and regulatory compliance, helping to ensure your innovativ
 e medical products to be safe and effective on a global market and sav
 ing enormous amount of your unnecessary time, efforts and investment.\
 nThis 60-min webinar will provide great opportunities for you to get f
 amiliar with regulatory and quality requirements for design control an
 d CAPA systems applicable to all types of medical devices including IV
 Ds.\nThis webinar is intended to help you learn and ensure you can imp
 lement adequate CAPA and design control procedures. In addition, this 
 webinar will provide an opportunity to better understand and adequatel
 y implement adequate design control and CAPA systems.\nAreas Covered i
 n the Session :\nApplicable Laws and Regulations\nStatutory and Regula
 tory Requirements\nIntroduction and Definitions\nDesign and Developmen
 t Planning\nDesign Input and Design Output\nDesign Review\nDesign Veri
 fication And Validation\nDesign Transfer and Design Changes\nDesign Hi
 story File (DHF), Device History Record (DHR) and Device Master Record
  (DMR)\nCorrective and Preventive Action (CAPA)\nRoot Cause Analysis\n
 CAPA Elements\nCommon Problems\nHow to Avoid Common Mistakes\nSpeakerâ
 €™s Recommendation and Suggestions on PASS-IT Solutions\nWho Will Bene
 fit:\nCEOs\nVPs\nCompliance Officers\nClinical Affairs (Associates, Sp
 ecialists, Managers, Directors and VPs)\nRegulatory Affairs (Associate
 s, Specialists, Managers, Directors and VPs)\nQuality Assurance (Assoc
 iates, Specialists, Managers, Directors and VPs)\nR&D (Engineers, Scie
 ntists, Managers, Directors and VPs)\nCROs\nConsultants\nContractors/S
 ubcontractors\nPrice tags:\nLive\nSingle Live : For One Participant\n$
  249\nCorporate Live : For Max. 10 Participants\n$ 899\nRecording\nSin
 gle REC : For One Participant - Unlimited Access for 6 Months\n$ 299\n
 For more information and enquiries contact us at\nCompliance Trainings
 \n5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada  Customer Su
 pport : #416-915-4458  Email : support@compliancetrainings.com\nFor 
 more information about this event please visit\nhttps://compliancetrai
 nings.com/SiteEngine/ProductDetailView.aspx?id=MD1684\n\nFor more info
 rmation visit https://medtechiq.ning.com/events/webinar-on-implementin
 g-adequate-capa-and-design-control-1
DTSTART;TZID=America/New_York:20160225T130000
DTEND;TZID=America/New_York:20160225T140000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:https://compliancetrainings.com/SiteEngine/ProductDetailView.a
 spx?id=MD1684
URL:https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?
 id=MD1684
CONTACT:4169154458
ORGANIZER:Compliance Trainings
ATTACH;FMTTYPE="image/jpeg":
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=complianc
 etrainings:https://medtechiq.ning.com/profile/compliancetrainings
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