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:78672
DTSTAMP:20260524T083805Z
SUMMARY:Webinar On \"Engineering Change Control for Medical Devices\"
DESCRIPTION:\nDescription :\nThis webinar will describe a system, base
 d on the regulations and practical experience that will allow for effi
 cient control of the change process. It will be compliant but not cumb
 ersome or overly time consuming. The difference between pre release an
 d post release change control will be explained. Methods to control th
 e transfer and approval of changes between the company and its supplie
 rs or contract manufacturers will be explained. Change control forms w
 ill be provided and described in detail.Why\nFDA and ISO call for chan
 ge control but do not provide any further guidance as to how to create
  a compliant system. The situation gets complicated when a company has
  suppliers or contract manufacturers and changes and approvals must pa
 ss from one to the other. This webinar will describe a system, based o
 n the regulations and years of practical experience that will allow fo
 r efficient control of the change process. It will be compliant but no
 t cumbersome or overly time consuming. Change control forms will be pr
 ovided and explained\n\n\n\n\nAreas Covered in the Session :\n\nChange
  control procedure\nPre release and post release change control\nChang
 e transfer between company and suppliers\nForms and SOP’s\n\n\n\n\n\
 nWho Will Benefit:\n\nDevelopment Engineers\nProduction Management\nQA
 / QC personnel\nEngineering management\nRegulatory personnel\n\n\n\n\n
 \nAbout Speaker:\nEdwin Waldbusser retired from industry after 20 year
 s in management of development of medical device products and developm
 ent of company Quality Systems. Products included IVD devices, kidney 
 dialysis systems and inhalation devices. QS experience includes design
  control, risk analysis, CAPA, software validation, supplier qualifica
 tion/ control and manufacturing/ non-conforming product programs. Edwi
 n Waldbusser has a B.S. Mechanical Engineering from NYU and a M.B.A fr
 om Drexel University. He is certified by Lloyds of London as an ISO 90
 00 Lead Auditor and is a member of the Thomson Reuters Expert Witness 
 network. He has 5 issued patents.\n\n\n\n\n\n\nFor more information vi
 sit https://medtechiq.ning.com/events/webinar-on-engineering-change-co
 ntrol-for-medical-devices
DTSTART;TZID=America/New_York:20180315T130000
DTEND;TZID=America/New_York:20180315T140000
CATEGORIES:online, "/", webinar
LOCATION:Online
WEBSITE:https://www.compliancetrainingpanel.com/Webinar/Topic?WB=MD000
 85
URL:https://www.compliancetrainingpanel.com/Webinar/Topic?WB=MD00085
CONTACT:1-844-216-5230
ORGANIZER;CN="Sam Miller":https://medtechiq.ning.com/profile/SamMiller
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562016959?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Sam Mill
 er":https://medtechiq.ning.com/profile/SamMiller
END:VEVENT
END:VCALENDAR