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DTSTART:19700308T020000
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UID:2140535:Event:68433
DTSTAMP:20260411T174744Z
SUMMARY:Webinar on Continued Process Verification - Process Monitoring
DESCRIPTION:Description :\nThe FDA’s Process Validation Guidance cal
 ls for “Continued Process Verification” in Stage 3 of the Guidance
  which focuses on continual assessment of process performance and prod
 uct quality throughout the life of the product. Combining process cont
 rol with process improvement creates a system that satisfies the direc
 tion of ICH Q8 (R2) and FDA’s guidance for continued process verific
 ation, continuous improvement and life cycle management. This presenta
 tion describes a disciplined and structured “Quality by Design” ap
 proach to achieve this objective.\nThe QbD “Design Space” concept 
 has been given much attention by pharma and biotech industries but muc
 h less attention has been given to implementation of “process contro
 l” systems needed to keep the process in-control and consistently pr
 oducing quality product. Process data are routinely analyzed at two le
 vels to assess process stability and capability. During the production
  of each batch data are collected by the process operators and Quality
  Control to assure within batch stability and capability and that appr
 opriate actions are taken when needed. On a monthly or quarterly basis
 , the batch-to-batch variation in product parameters is analyzed to as
 sess the long-term stability and capability of the process. This syste
 m is illustrated and discussed in detail. Critical questions and chall
 enges are identified. Connections of this system to process robustness
  are also addressed.\nAreas Covered in the Session :\nFDA Guidance reg
 arding Process Validation and Continued Process Verification\nBuilding
  Blocks of QbD – Design Space, Process Control and Assessing Risk\nP
 rocess Control Strategy - Stability and Capability Methods\nProcess Pe
 rformance and Product Quality - A Systems Approach\nThe Vision  for P
 rocess Monitoring and Control Building Blocks\nSuccessful Deployment, 
 Getting Started and Sustaining the Initiative\nTips and traps – What
  to watch out for\nWho Will Benefit:\nExecutives and Managers of Pharm
 a and Biotech Companies\nProcess and Manufacturing Engineers\nQuality 
 Assurance Personnel\nRegulatory Affairs Professionals\nQuality Control
  Lab Personnel\nQuality Engineers\nResearch and Development Scientists
 \nBiologists and Microbiologists\nChemists and Chemical Engineers\nFor
  more information and enquiries contact us at\nCompliance Trainings\n5
 939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada  Customer Suppo
 rt : #416-915-4458  Email : support@compliancetrainings.com\nFor mor
 e information about this event please visit\nhttps://compliancetrainin
 gs.com/SiteEngine/ProductDetailView.aspx?id=FDB1437\n\nFor more inform
 ation visit https://medtechiq.ning.com/events/webinar-on-continued-pro
 cess-verification-process-monitoring
DTSTART;TZID=America/New_York:20160310T130000
DTEND;TZID=America/New_York:20160310T140000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:https://compliancetrainings.com/SiteEngine/ProductDetailView.a
 spx?id=FDB1437
URL:https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?
 id=FDB1437
CONTACT:4169154458
ORGANIZER:Compliance Trainings
ATTACH;FMTTYPE="image/jpeg":
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=complianc
 etrainings:https://medtechiq.ning.com/profile/compliancetrainings
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