Validation to Upstream and Downstream Processes

This course may be taught at any location.

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Validation of Upstream and Downstream Processes
Level: Advanced
Lecture Hours: 6.00
Lab Hours: 2.00
Total Contact Hours: 8.00


This course will provide a detailed overview of the series of activities required for validation of a biopharmaceutical process, which take place over a product’s life cycle. Through interactive workshops and hands-on preparation of validation documentations, participants will gain a better understanding of the specific activities required for the validation of both upstream and downstream processes.

Topics Include

This 1 day, 8 hour course covers the following topics:

  • Upstream and Downstream bioprocess overview
  • Green Fluorescent Protein production process overview
  • Roadmap of activities involved in Process Validation
  • Application of Failure Modes and Effects Analysis (FMEA)
  • Determination of Proven Acceptable Range (PAR)
  • Generation of a Process Validation Master Plan
  • Validation of Upstream and Downstream Processing
  • Preparation of Upstream and Downstream Process qualification protocols
  • Preparation of GFP process resin reuse validation protocols
  • Discussions on how to handle deviations and out of specification results
  • Process Qualifications protocols
  • Regulatory Submissions

Learning Objectives

Upon successful completion, participants will be able to:

  • Describe process design, process qualification, and continued process monitoring
  • Differentiate between activities required for validation of upstream versus downstream processing
  • Conduct a Failure Modes and Effects Analysis (FMEA) of Batch Production Records
  • Identify requirements for handling deviations and out of specification results


The course is designed for bioprocess engineers, technicians and operators, Quality Assurance, Quality Control, compliance and regulatory personnel who have validation responsibilities. The class is also designed for individuals seeking industry training in developing validation programs, plans and documentations for upstream and downstream processes in the biotechnology field.