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

MessageThis Webinar is over
Date Oct 4, 2018
Time 11:00 PM EDT
Cost $93940.00
Why You Should Attend:

This training program will illustrate how these two different concepts are integrated (Phase 1, 2, and 3 vs. Stages 1, 2, and 3) and where do they merge. Attendees will learn if they exist independently of each other or do they complement each other to enhance, build and provide a product.
This seminar will provide a channel to enhance understanding of the utilization of process validation and Phase 1, 2 and 3, where their guidance blend and where they remain distinct. In particular, Stage 3 continued process verification, will be reviewed in detail: where does it begin; what is included; and, when does it end.

Key Learning Objectives:
  • Why these FDA Guidance/EU Guidelines for Industry – Process Validation is so important to the pharmaceutical and biotechnology industry.
  • What FDA segments are included and excluded within the “NEW” Process Validation.
  • Where does the Process Validation commence.
  • What are the Three Stages and Where They Apply within the NEW Process Validation.
  • How Stage 1 integrates with Phase 1.
  • The Validation approaches that are included within this Guidance document.
  • The Statutory and Regulatory Requirements for Process Validation.
  • An Introduction Phase 1 Guidance for Industry and Its Application within the “NEW” Process Validation.
  • The Phase 1 Investigational Drug Requirements – What is and What is NOT Required.
  • General Considerations for Process Validation – Stage 2 Process Qualification.
  • Regulatory Strategies for Phase 2 and 3 and their Incorporation within Stages 1 and 2.
  • General Considerations for Process Validation – Stage 3 Continued Process Verification.
  • A Review of EU Annex 15 and its Comparison to FDA’s Process Validation Guidance.

Who Should Attend:
Important: Please plan to bring a multidisciplinary group from your Company to gain the most from this very important seminar.
  • Quality Assurance Departments
  • Quality Control Departments
  • Regulatory Compliance Departments
  • Validation Teams
  • Product Development Teams
  • Project Management Teams
  • Engineering Departments
  • Manufacturing Departments
  • Contract Manufacturers
  • Internal Auditors
  • Facilities Professionals


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