Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation)

  • 02-03 Mar 2020
  • Easton, MA, United States

Description

Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation) is a conference that covers topics such as:

  • Where does the Process Validation commence
  • What FDA segments are included and excluded within the "NEW" Process Validation
  • How Stage 1 integrates with Phase 1
  • What are the Three Stages and Where Do They Apply within the NEW Process Validation
  • The Statutory and Regulatory Requirements for Process Validation
  • The Validation approaches that are included within this Guidance document
  • The Phase 1 Investigational Drug Requirements -- What is and What is NOT Required
  • An Introduction tPhase 1 Guidance for Industry and Its Application within the "NEW" Process Validation
  • Regulatory Strategies for Phase 2 and 3 and their Incorporation within Stages 1 and 2
  • General Considerations for Process Validation - Stage 2 Process Qualification
  • A Review of EU Annex 15 and its Comparison tFDA`s Process Validation Guidance
  • General Considerations for Process Validation - Stage 3 Continued Process Verification

Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation) brings together:

  • Project Management
  • Product Development
  • Quality Assurance
  • Regulatory Compliance
  • Manufacturing and Facilities professionals
  • Quality Control

Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation) will be held in Easton, MA, United States on 02-03 Mar 2020.

Venue

Easton,
Massachusetts,
United States
  View all Hotels near Venue

More Details

1599 US Dollar
ComplianceOnline

Future Events

  • Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation) - 02-03 Mar 2020, Easton, MA, United States (67243)

Past Events

  • Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation) 2019 - 06-07 May 2019, Residence Inn by Marriot Boston Cambridge, Cambridge, MA, United States (60559)
  • Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation) 2018 - 04-05 Oct 2018, Double Tree by Hilton Raleigh - Brownstone-University, Raleigh, NC, United States (77024)
  • Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation) 2018 - 10-11 May 2018, Boston, MA, United States (67244)

Important

Please, check the official conference website for possible changes, before you make any traveling arrangements

Prices are for evaluation only.

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