Process Validation in Biotechnology Manufacturing (T32)

Level: Advanced
Type: Classroom Training Course
ISPE CEUs: 1.5
Includes Webinar

Date Location Country Instructor(s)
This course is not currently scheduled, but may be conducted at your company. Please contact ISPE for more information.


The inherent complexity and uncertainty of biotechnology makes developing and validating bioprocesses for manufacturing proteins and biopharmaceuticals very difficult. Understanding and using FDA's new Process Validation Guideline is critical to establishing and maintaining control of complex processes, as well as achieving regulatory approval of new products.

This course is designed to provide a clear understanding of the regulatory, scientific, and engineering tools required to successfully develop and validate bioprocesses. In addition, the course identifies the long list of activities required to validate biopharmaceutical processes.

Topics include a comprehensive strategy to process validation; a review of important biotechnology manufacturing processes, and the regulatory requirements for their validation.

In addition to classroom lectures, participants will take part in several interactive exercises, solve group problems, and participate in class discussions to understand the underlying principles behind Process Validation.

This is an advanced course. Participants should have a basic understanding of commissioning, qualification and validation and basic familiarity with biotechnology manufacturing processes and unit operations.

Course Modules

  • Introduction
    • The evolving definition of Process Validation
    • Quality of Information and its significance
    • Good Manufacturing Practices
  • Q8 Pharmaceutical Development
    • Definition of Design Space
    • Attributes and parameters
  • USFDA's New Process Validation Guidelines
    • The new validation paradigm
    • Quality by Design (QbD) concepts and their application
  • Manufacturing Sciences - Validation tools
    • Design Space concepts
    • Experimental models
    • Overview of DOE Methods
    • Mathematical models
    • PAT - Process & Product Control
    • Risk Analysis - ICH Q9
  • Product Definition - CQA
  • Activities required for Process Validation
    • Process Master Plan elements
    • Cell Bank validation
    • Viral clearance validation
    • Conformance lots
  • Process Verification
    • SPC tools for verification
  • Legacy products
  • Validation of Bioprocess Unit Operations
    • Fermentation & Cell Culture
    • Harvest & Recovery
    • Tangential Flow Filtration (TFF)
    • Chromatography
  • Course Quiz

Includes Webinar 

This course includes a pre-recorded Webinar that provides a review of the basics prior to the classroom course. Access information will be provided via email one week prior to the start of the training event.

Webinar Learning Objectives

  • Understand the importance of process validation as a means of minimizing the concerns related to biotechnology processes and effectively deal with the inherent uncertainties associated with biotech manufacturing.
  • Review the basic concepts behind process validation.
  • Define and explain a framework for structuring process validation activities for new pharmaceuticals.
  • Identify and describe many of the tools used to execute the activities required to validate both the process and unit operations in a manufacturing facility.

Take Back to Your Job

  • Develop and execute validation master plans and validation protocols
  • Understand and use FDA's current process validation guidelines
  • Successfully run conformance lots for process qualification
  • Define key validation activities for biopharmaceutical process development and manufacturing
  • Apply strategies and fundamental approaches for process validation of upstream and downstream processes for clinical and commercial manufacturing
  • Discuss validation documentation requirements

Attendance Suggested For

  • Process development engineers, validation personnel, manufacturing supervisors and managers, quality assurance specialists, and management personnel.
  • Senior manufacturing and engineering managers who want to understand the regulatory and scientific requirements associated with process validation.
  • Other professionals with commissioning, qualification, and validation responsibilities who need an understanding of process validation for biotechnology manufacturing.

Community of Practice (COP)

This training course is of particular interest to existing and future members of the ISPE Biotechnology and Process/Product Development Community of Practice (COP).

Continuing Education Units 

ISPE will provide continuing education units (ISPE CEUs) for all North American seminars and courses, including educational programming at the ISPE Annual Meeting. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession.

Delegates attending European seminars and courses will receive a Certificate of Attendance, as ISPE CEUs are currently not offered at European events. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be sent via email within four weeks of evaluation materials. One hour of education programming equals 0.1 ISPE CEU credits.

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