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UID:2140535:Event:67019
DTSTAMP:20260523T004913Z
SUMMARY:Webinar On U.S. FDA Project Management
DESCRIPTION:Description :\nThis webinar is not a project management ce
 rtification course. However, it is designed to provide the tools neces
 sary to assist those designing a result or deliverable to achieve that
  end. It will provide valuable guidance to regulated companies in deve
 lopment and implementation of Project Management Planning and Techniqu
 es for new product development, regulatory compliance audit responses,
  proof of \"progress against plan\", and other activities requiring a 
 planned documented rationale. Three of the most common tools will be d
 iscussed. Common variants such as \"dashboards\" will also be presente
 d. Lean and Agile principles will be discussed, including potential pi
 tfalls. A very simple approach using common Excel- or Word-type PC app
 lications programs that can be used immediately will be highlighted. R
 egular use of a few simple but powerful tools will virtually eliminate
  \"fire fighting\" in a new project. Regular use can contribute greatl
 y to reduction of scheduling uncertainty, incomplete projects when tim
 e is running out, increased product liability, assist in company-wide 
 cost reduction efforts, with less chance of recalls, and an improved b
 ottom line.\nThe FDA expects companies to manage projects formally -- 
 to include regulatory requirements, design and/or change control, with
  consideration of all applicable standards.  The EU MDD and their not
 ified bodies are no different.\nHow can this be done from a project's 
 inception?\nHow can a Project Leader or Project Manager ensure critica
 l elements are not omitted until late in the project when disaster loo
 ms?\nHow to minimize scope creep?\nWhat are the \"lean\" and \"Agile\"
   benefits and shortcomings in the cGMP environment?\nWhat is \"faili
 ng fast\" in the \"build-measure-learn, re-evaluate / decide loop?\nHo
 w to gain management support for the Milestones, Tasks, Timelines?\nUs
 e the Plan as a powerful tool with FDA auditors. Use variations on the
 se tools for any project, from the smallest to major company projects.
  These techniques are not rocket-science, but require the implementati
 on of formal methods with documented, and defensible rationale. Use th
 ese tools to bring predictability to your company's product developmen
 t process. Use them to defend your remediation efforts with the FDA. U
 se them to prove \"progress against plan\".\nAreas Covered in the Sess
 ion :\nThe three most common PM tools -- Gantt, CPM, PERT + others\nWo
 rk breakdown structure, milestones, tasks\nLean and Agile principles, 
 advantages and potential problems\nDrive success over failure fast\nTh
 e build, leisure, learn,  re-evaluate loop\nA template / example\nOne
  major but often neglected use\n \nWho Will Benefit:\nPrinciples in t
 his webinar will apply to personnel / companies in the Medical Devices
 , Pharmaceutical, Diagnostic, and Biologics fields. The professionals 
 who will benefit include all:\nSenior management\nMiddle management\nR
 &D\nEngineering\nSoftware\nQA / RA\nManufacturing Teams\nOperations Te
 ams\nConsultants\ncGMP instructors\nProduction Teams\n\nFor more infor
 mation visit https://medtechiq.ning.com/events/webinar-on-u-s-fda-proj
 ect-management
DTSTART;TZID=America/New_York:20151007T130000
DTEND;TZID=America/New_York:20151007T140000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:https://compliancetrainings.com/SiteEngine/ProductDetailView.a
 spx?id=FDB1546
URL:https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?
 id=FDB1546
CONTACT:4169154458
ORGANIZER;CN=compliancetrainings:https://medtechiq.ning.com/profile/co
 mpliancetrainings
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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