Validation Concepts in Biopharmaceutical Manufacturing

Participants explore the history of validation, the approaches of validation, and what equipment must be validated

The course covers the fundamentals and importance of all aspects of validation with a focus on equipment validation (IQ and OQ) in the manufacturing of biopharmaceuticals and gain hands-on experience with temperature mapping and analysis of mapping data of critical equipment. 

Participants gain knowledge in the history of validation, the approaches of validation, and what equipment must be validated.  The course covers the fundamentals and importance of all aspects of validation with a focus on equipment validation (IQ and OQ) in the manufacturing of biopharmaceuticals and gain hands-on experience with temperature mapping and analysis of mapping data of critical equipment. 

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Objectives

  • Attain knowledge about the history of validation and how to validate equipment.
  • Understand the fundamentals and importance of validation, including IQ and OQ, needed for biopharmaceutical manufacturing.
  • Perform hands-on techniques including temperature mapping, including pre-calibration, and analysis of the mapped data from critical equipment.

Who should attend this course?

Course work and laboratory exercises are designed for individuals working in the biomanufacturing industry including roles such as Upstream and Downstream Technicians, Quality Assurance, Quality Control, Bioprocess Engineers, Facilities, and Plant Operations. 

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Delivery

In-person lectures and hands on activities in a simulated GMP facility.       

  • Duration: 1.5 Days
  • Time: Day 1: 8:00am to 4:00pm, Day 2: 8:00am – noon
  • Location: Kingston, RI
  • Max Number of Participants: 15

 

Instructors

Jennifer Lewis, Ph.D.

Associate Director Analytical Development/QC

Avedisian Hall 395L

401.874.9093
jenlewis@uri.edu

Content Outline

Day 1

  1. History of Validation
  2. What is Validation/Regulation Overview
  3. Validation Disciplines Overview
  4. When Do You Validate and How
  5. Basics of Equipment Validation
  6. Installation Qualification Overview
  7. Operational Qualification Overview
  8. Temperature Mapping Exercise
    • TC Pre Calibration

Day 2

  1. Temperature Mapping Exercise continued
    • Thermal Mapping
    • Breakdown of Equipment
    • TC Post Verification
  2. Group Breakouts for Analysis of All Data
  3. Team Review of Data