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UID:2140535:Event:472015
DTSTAMP:20260405T171035Z
SUMMARY:Process Validation Guidance Requirements
DESCRIPTION:The Process Validation Guidelines (January 2011) and the E
 U Annex 15: Qualification and Validation (October 2015) outline the ge
 neral principles and approaches the two regulatory bodies consider app
 ropriate elements of process validation for the manufacture of human a
 nd animal drugs and biological products, including Active Pharmaceutic
 al Ingredients (APIs). These guidances align Process Validation activi
 ties with a product lifecycle concept and with existing FDA and EU gui
 dances, including the FDA/International Conference on Harmonization (I
 CH), Guidance for Industry, Q8 (R2) Pharmaceutical Development, Q9 Qua
 lity Risk Management, and Q10 Pharmaceutical Quality System. The lifec
 ycle concept, new to these Guidances, link product and process develop
 ment, qualification of the commercial manufacturing process, and maint
 enance of the process in a state of control during routine commercial 
 production. These guidances also support process improvement and innov
 ation through sound science and risk management. The new Process Valid
 ation Guideline/Practice incorporate elements of Process Validation as
  early as the Research and Development phase, and continues onward thr
 ough Technology Transfer, into the Phase 1 IND Clinical Trial manufact
 uring phase, and ultimately into Phase 2 and 3, and then commercial ma
 nufacturing.\nEach facility, whether producing small or large molecule
 s requires both an overall Site Validation Plan as well as specific va
 lidation plans to manage the multiplicity of validations required to c
 onfirm the successful manufacture of each of its products.\n\nLearning
  Objectives:\nWhy these FDA Guidance/EU Guidelines for Industry - Proc
 ess Validation is so important to the pharmaceutical and biotechnology
  industry.\n\nWhat FDA segments are included and excluded within the \
 "NEW\" Process Validation.\nWhere does the Process Validation commence
 .\nWhat are the Three Stages and Where They Apply within the NEW Proce
 ss Validation.\nHow Stage 1 integrates with Phase 1.\nThe Validation a
 pproaches that are included within this Guidance document.\nThe Statut
 ory and Regulatory Requirements for Process Validation.\nAn Introducti
 on to Phase 1 Guidance for Industry and Its Application within the \"N
 EW\" Process Validation.\nThe Phase 1 Investigational Drug Requirement
 s -- What is and What is NOT Required.\n\nWho Will Benefit:\nThose who
  will benefit from this ON-LINE seminar include\n\nProduct Development
 \nProject Management\nRegulatory Compliance\nQuality Assurance\nQualit
 y Control\nManufacturing and Facilities professionals who are required
  to develop and participate in understanding issues surrounding Proces
 s Validation.\n\n\nFor more information visit https://medtechiq.ning.c
 om/events/process-validation-guidance-requirements
DTSTART;TZID=America/New_York:20220331T100000
DTEND;TZID=America/New_York:20220401T160000
CATEGORIES:seminae
LOCATION:online
WEBSITE:https://www.complianceonline.com/fda-eu-annex15-ich-process-va
 lidation-qualification-cgmp-ppq-seminar-training-80375SEM-prdsm?channe
 l=MedTech%20I.Q
URL:https://www.complianceonline.com/fda-eu-annex15-ich-process-valida
 tion-qualification-cgmp-ppq-seminar-training-80375SEM-prdsm?channel=Me
 dTech%20I.Q
CONTACT:8887172436
ORGANIZER;CN=ComplianceOnline:https://medtechiq.ning.com/profile/Refer
 ral512
ATTACH;FMTTYPE="image/jpeg":https://storage.ning.com/topology/rest/1.0
 /file/get/10168481285?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc
 eOnline:https://medtechiq.ning.com/profile/Referral512
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