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DTSTAMP:20260412T184709Z
SUMMARY:Online Webinar on Process Verification and Validation
DESCRIPTION:Overview: This webinar will provide valuable guidance to r
 egulated companies in development, implementation, or refinement of th
 eir manufacturing process verification and validation programs.It will
  evaluate validation practices that are more in agreement with ICH Q7 
 and Q8 than previously accepted validation methods, and will provide t
 hought-provoking questions for FDA-regulated companies. Enhanced use o
 f existing FDA tools by a company will be discussed. What are the expe
 cted industry trends for the future as indicated by recent FDA and oth
 er guidance documents, for which companies should now prepare?\nWhy Sh
 ould You Attend: The FDA expects companies to perform meaningful, resu
 lts driven manufacturing process validation, now including considering
  life cycle issues. While the company is held fully responsible for de
 ciding how it will conduct process validation, alternate approaches re
 quire longer and more stringent documented rationale. Growing high-pro
 file field problems indicate that validation and change control and it
 s effect on regulatory review activities are not yet fully utilizing t
 he power of current FDA guidance and associated tools, which must be a
  part of such an analysis. A growing push by the Agency to toughen the
  regulatory process in the U.S. is one result. Current methods are cla
 imed to not be providing the product safety or efficacy seemingly prom
 ised. For most companies, the fixes are not rocket-science, but requir
 e the implementation of formal methods with documented and defensible 
 rationale.\nAreas Covered In the Session:Key process validation requir
 ementsCurrent expectationsRecent process validation guidance documents
 Lifecycle considerationsExpectations for the future as indicated by IC
 H Q7 and Q8The \"Controlled Process\"\nWho will benefit:Senior Managem
 entRegulatory AffairsQuality AssuranceProductionR&D and EngineeringAll
  personnel tasked with process verification and validation\nSpeaker Pr
 ofile:John E Lincoln is a medical device and regulatory affairs consul
 tant. He has helped companies to implement or modify their GMP systems
  and procedures, product risk management, U.S. FDA responses. In addit
 ion, he has successfully designed, written and run all types of proces
 s, equipment and software qualifications/validations, which have passe
 d FDA audit or submission scrutiny, and described in peer-reviewed tec
 hnical articles, and workshops, world wide.\nContact Detail:Compliance
 4All DBA NetZealous,Phone: +1-800-447-9407Email: support@compliance4Al
 l.comhttp://www.compliance4all.com/Event Link : http://bit.ly/Process_
 VerificationLinkedIn Like us – https://www.linkedin.com/company/comp
 liance4all-trainingsTwitter Follow usFacebook Like us\n\nFor more info
 rmation visit https://medtechiq.ning.com/events/online-webinar-on-proc
 ess-verification-and-validation
DTSTART;TZID=America/New_York:20160629T100000
DTEND;TZID=America/New_York:20160629T110000
CATEGORIES:webinar
LOCATION:Online Event
WEBSITE:http://www.compliance4all.com/
URL:http://www.compliance4all.com/
CONTACT:8004479407
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/2562012284?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Adam Fle
 ming":https://medtechiq.ning.com/profile/Compliance4all
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