ISPE CEUs: 1.5
Type: Classroom Training Course
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
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.
- 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)
- Course Quiz
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
- Review the basic concepts behind process validation.
- Define and explain a framework for structuring process validation activities for new
- 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 and European
courses. CEUs are nationally recognized units of achievement designed for those individuals continuing
their education in their chosen field or profession. Verification of CEUs is based on attendance as
well as satisfactory completion of all evaluation materials. Statements of credit will be available for
download in your ISPE account within four weeks of the completion of training. Instruction for download
will be sent when the CEUs are available. One hour of education programming equals 0.1 ISPE CEU