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DESCRIPTION:The Process Validation Guidelines (January 2011) and the EU An
 nex 15: Qualification and Validation (October 2015) outline the general p
 rinciples and approaches the two regulatory bodies consider appropriate e
 lements of process validation for the manufacture of human and animal dru
 gs and biological products\, including Active Pharmaceutical Ingredients 
 (APIs). These guidances align Process Validation activities with a produc
 t lifecycle concept and with existing FDA and EU guidances\, including th
 e FDA/International Conference on Harmonization (ICH)\, Guidance for Indu
 stry\, Q8 (R2) Pharmaceutical Development\, Q9 Quality Risk Management\, 
 and Q10 Pharmaceutical Quality System. The lifecycle concept\, new to the
 se Guidances\, link product and process development\, qualification of th
 e commercial manufacturing process\, and maintenance of the process in a 
 state of control during routine commercial production. These guidances al
 so support process improvement and innovation through sound science and r
 isk management. The new Process Validation Guideline/Practice incorporate
  elements of Process Validation as early as the Research and Development 
 phase\, and continues onward through Technology Transfer\, into the Phase
  1 IND Clinical Trial manufacturing phase\, and ultimately into Phase 2 a
 nd 3\, and then commercial manufacturing.\n\nEach facility\, whether prod
 ucing small or large molecules requires both an overall Site Validation P
 lan as well as specific validation plans to manage the multiplicity of va
 lidations required to confirm the successful manufacture of each of its p
 roducts.\n\nThis FIVE HOUR/DAY\, interactive ON-LINE Seminar which provid
 es a conduit to enhance your understanding of the Continued Process Verif
 ication\, will be reviewed in detail: where does it begin\; what is inclu
 ded\; and\, when does it end.\n\nCommon questions asked by the users of P
 rocess Validation include\;\n\n\nHow does one integrate these two differe
 nt concepts (Phase 1\, 2\, and 3 vs. Stages 1\, 2\, and 3) and where do t
 hey merge?\nDo they exist independently of each other or do they compleme
 nt each other to enhance\, build and provide a product that neither alone
  could. Questions that may arise include where are cGMPs initiated?\nTo w
 hat extent must they be used? Since Stage 3 extends through commercial ba
 tch manufacturing\, what happens to Phase 3?\nDoes it follow along or wit
 h Stage 3? Questions that exist include how one manages special situation
 s to include viral inactivation and removal\, impurity clearance\, proces
 s consistency\, process solution stability\, endotoxin\, bioburden\, and 
 other miscellaneous cell culture tests to include DNA and host cell prote
 in.\n\nThese questions will be addressed within Stage 2 as presented here
  and include utilization of Process Validation and Phase 1\, 2 and 3\, wh
 ere their Guidances blend and where they remain distinct. In particular\,
  Stage 3.\n\nLearning Objectives:\nWhy these FDA Guidance/EU Guidelines f
 or Industry - Process Validation is so important to the pharmaceutical an
 d biotechnology industry.\n\n\nWhat FDA segments are included and exclude
 d within the "NEW" Process Validation.\nWhere does the Process Validation
  commence.\nWhat are the Three Stages and Where They Apply within the NEW
  Process Validation.\nHow Stage 1 integrates with Phase 1.\nThe Validatio
 n approaches that are included within this Guidance document.\nThe Statut
 ory and Regulatory Requirements for Process Validation.\nAn Introduction 
 to Phase 1 Guidance for Industry and Its Application within the "NEW" Pro
 cess Validation.\nThe Phase 1 Investigational Drug Requirements -- What i
 s and What is NOT Required.\nGeneral Considerations for Process Validatio
 n - Stage 2 Process Qualification.\nRegulatory Strategies for Phase 2 and
  3 and their Incorporation within Stages 1 and 2.\nGeneral Considerations
  for Process Validation - Stage 3 Continued Process Verification.\nA Revi
 ew of EU Annex 15 and its Comparison to FDA’s Process Validation Guidance
 .\n
DTEND:20211203T040000
DTSTAMP:20260512T225907Z
DTSTART:20211202T100000
LOCATION:6201 America Center Drive\, Suite 240\, San Jose\, CA\, 95002\,
SEQUENCE:0
SUMMARY:The Process Validation Guidelines (January 2011) and the EU Annex 
 15: Qualification and Validation (October 2015) outline the general princ
 iples an...
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