BEGIN:VCALENDAR PRODID:NingEventWidget-v1 VERSION:2.0 METHOD:PUBLISH BEGIN:VTIMEZONE TZID:America/New_York X-LIC-LOCATION:America/New_York BEGIN:DAYLIGHT TZOFFSETFROM:-0500 TZOFFSETTO:-0400 TZNAME:EDT DTSTART:19700308T020000 RRULE:FREQ=YEARLY;BYMONTH=3;BYDAY=2SU END:DAYLIGHT BEGIN:STANDARD TZOFFSETFROM:-0400 TZOFFSETTO:-0500 TZNAME:EST DTSTART:19701101T020000 RRULE:FREQ=YEARLY;BYMONTH=11;BYDAY=1SU END:STANDARD END:VTIMEZONE BEGIN:VEVENT UID:2140535:Event:66354 DTSTAMP:20260521T011643Z SUMMARY:Webinar On 9 Required Elements of Design Control System DESCRIPTION:Description :\nThe FDA expects companies to perform meanin gful, results driven Design Control activities as defined in 21 CFR 82 0.30, for both new and changed devices. The company is held fully resp onsible for deciding when to start and the specific documentation to m eet the 9 requirements. A review of recent information from the Agency , including recent Working Group findings and Reports, as well as othe r goals of the Agency that have already been translated into action in the field in the past several years, provide further direction in are as of concern and what to expect in the future.\nBeyond compliance, th ese 9 elements can be a powerful tool in reducing \"time to market\" / \"fast cycle\" product development. In addition, growing high-profile field problems indicate that design control and it’s effect on regu latory review activities are not yet fully utilizing the power of curr ent risk management tools, which must be a part of the design control process -- the ISO 14971 \"model\". A growing push by the Agency to st rengthen the 510(k) process, and review existing devices with above no rmal adverse events are additional concerns, to be factored into the d esign control process.\nNew “Agile” development methods bring adde d concerns. The resulting documentation can have other far-reaching us es in a company. Proper design control requires a defined \"start\" da te, and the systematic / SOP-defined implementation of formal methods with documented, and defensible, rationale. When properly executed, it can also be a powerful product development project management tool.\n Areas Covered in the Session :\nFDA Device Clearance / Changes in Dire ction\nCurrent Design Control Requirements\nDefining the \"Start\" Dat e and Its Significance\nThe  9 Design Control Elements and Their Impl ementation and Documentation\n\"Retroactive\" Design Control\n“Agile ” Design Control\nThe Business Case for Design Control\nInteractive Q & A session\n \nWho Will Benefit:\nThis webinar will provide valuab le assistance to all U. S. FDA-regulated companies. It will assist in their reviewing and modifying their regulatory compliance stance in vi ew of the areas the FDA indicates are of growing / future interest / e mphasis. Its principles apply to personnel / companies in the Medical Devices, Pharmaceutical, Diagnostic, and Biologics fields. The employe es who will benefit include:\nSenior management\nMiddle management\nR& D\nEngineering\nSoftware\nQA / RA\nManufacturing\nOperators\nConsultan ts\ncGMP instructors\nAnd all personnel involved in verification and/o r validation planning, execution and documentation.\n \nFor more info rmation and enquiries contact us at\nCompliance Trainings\n5939 Candle brook Ct, Mississauga, ON L5V 2V5, Canada  Customer Support : #416- 915-4458  Email : support@compliancetrainings.com\n\nFor more inform ation visit https://medtechiq.ning.com/events/webinar-on-9-required-el ements-of-design-control-system DTSTART;TZID=America/New_York:20150623T130000 DTEND;TZID=America/New_York:20150623T140000 CATEGORIES:webinar LOCATION:Online WEBSITE:https://compliancetrainings.com/SiteEngine/ProductDetailView.a spx?id=MD1543 URL:https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx? id=MD1543 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 END:VEVENT END:VCALENDAR