Process Validation in Biotechnology Manufacturing (T32)

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Training

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

Date	Location	Country	Instructor(s)
11-12 September 2013	Burlingame, California	USA	Mark Witcher
7-8 October 2013	(T32) - Cancelled Prague	Czech Republic	Bruce Williams

Description

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.

Last Update: 29 May 2013