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:66790
DTSTAMP:20260522T041733Z
SUMMARY:Webinar on 2011 FDA Guideline on Process Validation
DESCRIPTION:Overview: The FDA in 2011 instituted its latest interpret
 ation. Many have not chosen to take it seriously or change their busin
 ess model. The paradigm has shifted and this presentation will articul
 ate what has changed and how we need to react. Validation as derived f
 rom industry practice has a new spin. This presentation will take you 
 through that development and demonstrate how some in the industry have
  reacted to the new expectations.\nWhy should you attend: \nThis is a
  topic very near and dear to those who are involved with qualification
  and validation. Of all the topics regarding compliance this subject a
 rea has to be the most re-invented. Those in attendance will hear how 
 to approach the topic and what some companies are currently doing to m
 eet the expectation. If you are new to the topic or just want to learn
  more regarding this evolving area of compliance then consider attendi
 ng this session.  Areas Covered in the Session:\n\nWhat it means\nWhat
  it says\nWhat is in and what is out\nComparison of what has changed\n
 PPQ1 and PPQ2\nWhat is PV\nWhat is Qualification\nASTM 2500\nEuropean 
 interpretation\nInconsistencies\nHybrid compliance\nHyper-care\nThe 3X
  rule\nWhat is validation and what is not\n\n Who Will Benefit:\n\nCom
 pliance Personnel\nQA Personnel\nvalidation Personnel\n\n\n\nSpeaker P
 rofile:Louis Angelucci is a pharmaceutical professional and Certified
  Quality Engineer with over 20 years of experience in Quality Assuranc
 e, Quality Control, Validation, consent decree remediation as well as 
 cGMP Compliance in the Medical Device and Pharmaceutical industries. L
 ou has worked for several well know companies inclusive of Johnson & J
 ohnson, Bristol-Meyer Squibb, Pfizer, Schering Plough and Merck. This 
 work experience was acquired either as a direct employee or as a contr
 acting consultant while employed at Foster Wheeler and Aker Kvaerner. 
 As a consultant Lou has worked at various project locations both domes
 tically and overseas.\nContact Detail:\nNetZealous - Compliance4All, 1
 61 Mission Falls Lane, Suite 216,  Fremont, CA 94539, USA.  Phone: +1-
 800-447-9407  Email: support@compliance4All.com http://www.compliance4
 all.com/ Event Link : http://bit.ly/1WhE3Zn\n\n\n\nFor more informati
 on visit https://medtechiq.ning.com/events/webinar-on-2011-fda-guideli
 ne-on-process-validation
DTSTART;TZID=America/New_York:20151113T100000
DTEND;TZID=America/New_York:20151113T113000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:http://bit.ly/1WhE3Zn
URL:http://bit.ly/1WhE3Zn
CONTACT:18004479407
ORGANIZER;CN="Adam Fleming":https://medtechiq.ning.com/profile/Complia
 nce4all
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562012364?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Adam Fle
 ming":https://medtechiq.ning.com/profile/Compliance4all
END:VEVENT
END:VCALENDAR