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DTSTAMP:20260603T045326Z
SUMMARY:Webinar On \"Process Validation – Integrating ICH Q8, Q9 and
  Q10 into the Process Validation Process\"
DESCRIPTION:\nDescription :\nICH Q10, The Pharmaceutical Quality Syste
 m, which was released to the international pharmaceutical industry in 
 2008, includes the concept of the product lifecycle. Since that time, 
 the lifecycle approach has been applied to all aspects of pharmaceutic
 al products and processes. ICH Q8, Pharmaceutical Development, and ICH
  Q9, Quality Risk Management, are closely integrated with ICH Q10. In 
 2011, the FDA issued its Guidance for Industry, Process Validation: Ge
 neral Principles and Practices. This guidance integrates quality syste
 m concepts from ICH Q8, ICH Q9 and ICH Q10 including lifecycle and ide
 ntifies the three stages of the process validation lifecycle. The Euro
 peans followed with a similar guidance for process validation includin
 g the lifecycle concept. This has now been incorporated into the revis
 ed Annex 15: Qualification and Validation of the EU GMPs. Objective :\
 nThe objective of this webinar is that attendees will better understan
 d contemporary expectations for process validation and how these suppo
 rt the quality system approach to compliance.\n\n\n\n\n\nAreas Covered
  in the Session :\n\n\n\n\nThe FDA Guidance on process validation and 
 how the expectations found in this guidance correlate to:\nICH Q10; Th
 e Pharmaceutical Quality System\nICH Q9; Quality Risk management\nICH 
 Q8; Pharmaceutical Development\n\n\nThe three stages of process valida
 tion and what must be done during each stage.\nStage 1; Process Design
 \nStage 2; Process Qualification\nStage 3; Continued Process Verificat
 ion\n\n\nThe extension of the concept of process life cycle to test me
 thod validation.\n\n\n\n\n\nWho Will Benefit:\n\n\n\n\nManagement at a
 ll levels who are responsible for process development and validation\n
 Personnel who are responsible for\nProduct development\nProcess transf
 er\nProcess validation\nDemonstration that a process continues to perf
 orm in a state of control\n\n\n\n\n\nAbout Speaker:\nJohn G. (Jerry) L
 anese is an independent consultant with a focus on Quality Systems and
  the components of an effective Quality System. He received a BA and M
 S from Middlebury College and a Ph.D. in Analytical Chemistry from the
  University of Michigan and began his career teaching Analytical Chemi
 stry in a small liberal arts college. Dr. Lanese moved from the academ
 ic environment to the pharmaceutical industry where he has managed Ana
 lytical Research, Quality Control and Quality Assurance functions.\n\n
 \n\n\n\n\nFor more information visit https://medtechiq.ning.com/events
 /webinar-on-process-validation-integrating-ich-q8-q9-and-q10-into
DTSTART;TZID=America/New_York:20180726T130000
DTEND;TZID=America/New_York:20180726T143000
CATEGORIES:online, "/", webinar
LOCATION:Online
WEBSITE:https://www.compliancetrainingpanel.com/Webinar/Topic?WB=MP001
 02
URL:https://www.compliancetrainingpanel.com/Webinar/Topic?WB=MP00102
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/2562030916?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Sam Mill
 er":https://medtechiq.ning.com/profile/SamMiller
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