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DTSTAMP:20260517T220602Z
SUMMARY:Webinar on2011 FDA Guideline on Process Validation
DESCRIPTION:Overview: \nThe FDA in 2011 instituted its latest inter
 pretation. Many have not chosen to take it seriously or change their b
 usiness model. The paradigm has shifted and this presentation will art
 iculate what has changed and how we need to react. Validation as deriv
 ed from 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 qualifica
 tion and validation. Of all the topics regarding compliance this subje
 ct area 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 meet the expectation. If you are new to the topic or just want to l
 earn more regarding this evolving area of compliance then consider att
 ending this session.Areas Covered in the Session:\n\nWhat it means\nWh
 at it says\nWhat is in and what is out\nComparison of what has changed
 \nPPQ1 and PPQ2\nWhat is PV\nWhat is Qualification\nASTM 2500\nEuropea
 n interpretation\nInconsistencies\nHybrid compliance\nHyper-care\nThe 
 3X rule\nWhat is validation and what is not\n\nWho Will Benefit:\n\nCo
 mpliance Personnel\nQA Personnel\nvalidation Personnel\n\nSpeaker Prof
 ile:\n\nLouis Angelucci is a pharmaceutical professional and Certifie
 d Quality Engineer with over 20 years of experience in Quality Assuran
 ce, Quality Control, Validation, consent decree remediation as well as
  cGMP Compliance in the Medical Device and Pharmaceutical industries. 
 Lou has worked for several well know companies inclusive of Johnson & 
 Johnson, Bristol-Meyer Squibb, Pfizer, Schering Plough and Merck. This
  work experience was acquired either as a direct employee or as a cont
 racting consultant while employed at Foster Wheeler and Aker Kvaerner.
 \nContact Detail:\nNetZealous - Compliance4All,161 Mission Falls Lane,
  Suite 216,Fremont, CA 94539, USA.Phone: +1-800-447-9407Email: support
 @compliance4All.comhttp://www.compliance4all.com/Event Link : http://
 bit.ly/2011_FDA_Guideline_on_Process_Validation\n\n\n\nFor more inform
 ation visit https://medtechiq.ning.com/events/webinar-on2011-fda-guide
 line-on-process-validation
DTSTART;TZID=America/New_York:20160324T100000
DTEND;TZID=America/New_York:20160324T110000
CATEGORIES:webinar
LOCATION:Online Event
WEBSITE:
URL:
CONTACT:Event Manager
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
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