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UID:2140535:Event:471876
DTSTAMP:20260524T061309Z
SUMMARY:Project Management for FDA-Regulated Companies
DESCRIPTION:This project management training for FDA regulated compani
 es will show how you can meet key FDA and EU MDD regulatory requiremen
 ts for the project you manage. It will focus on proven tools and techn
 iques for successful development and implementation of project managem
 ent planning.\n\nWhy Should You Attend:\nThe FDA expects companies to 
 manage projects formally, with a written plan -- to include regulatory
  requirements, design and/or change control, with consideration of all
  applicable standards, and to demonstrate \"progress against plan\". T
 he EU MDD and their notified bodies are no different.\nHow can this be
  done from a project's inception? How can lean principles be incorpora
 ted from project inception? What is \"failing fast\" in the \"build, m
 easure, learn, re-evaluate / decide loop\"? Can Agile principles mesh 
 with FDA's documentation requirements? How can a Project Leader or Pro
 ject Manager ensure critical elements are not omitted until late in th
 e project when disaster looms? How to gain management support for the 
 Milestones, Tasks, Timelines?\nThis webinar will provide valuable guid
 ance to regulated companies in development and implementation of new L
 ean Project Management Planning concepts including some Agile principl
 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 
 discussed. \"Hit the ground running\" with one very simple approach us
 ing common Excel- or Word-type PC applications programs. Learn how reg
 ular use of a few simple but powerful tools will virtually eliminate \
 "firefighting\" in a new project.\n\nAreas Covered in the Webinar:\n\n
 Meet key requirements of the CGMPs/ISO; Quality Plans\n\"Failing Fast\
 " Formal Lean Project Management\nThe Three Most Common Tools - Gantt,
  CPM, PERT\nWork breakdown Structure, Milestones, Tasks\nDrive Success
  or Failure Fast; Fast Cycle / Agile Principles\nThe Build, Measure, L
 earn, Re-evaluate Loop\nExample: A Suggested New Product Template\n\nW
 ho Will Benefit:\nThis webinar will provide valuable assistance to all
  FDA-regulated companies that need an easy to implement, easy to expla
 in, and repeatable methodology. It will provide the basic tools to ass
 ist in-house personnel to be trained in project management tools and t
 echniques, targeted specifically to the regulated medical products ind
 ustries, under cGMP and EU MDD/CE-marking compliance. It will discuss 
 and provide examples of the most common project management tools and p
 rovide a major example for immediate use. This applies to companies in
  the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields.
  The employees who will benefit include:\n\nProject Managers\nSenior m
 anagement\nRegulatory affairs\nQuality Assurance / QAE\nProduction\nR&
 D and Engineering\n\n\nFor more information visit https://medtechiq.ni
 ng.com/events/project-management-for-fda-regulated-companies
DTSTART;TZID=America/New_York:20220330T100000
DTEND;TZID=America/New_York:20220330T130000
CATEGORIES:webinar
LOCATION:online
WEBSITE:https://www.complianceonline.com/project-management-for-fda-re
 gulated-companies-webinar-training-701758-prdw?channel=MedTech%20I.Q
URL:https://www.complianceonline.com/project-management-for-fda-regula
 ted-companies-webinar-training-701758-prdw?channel=MedTech%20I.Q
CONTACT:8887172436
ORGANIZER:Complianceonline
ATTACH;FMTTYPE="image/jpeg":https://storage.ning.com/topology/rest/1.0
 /file/get/10211600655?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc
 eOnline:https://medtechiq.ning.com/profile/Referral512
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