Process Validation for Biotechnology Manufacturing

ISPE CEUs*: 1.5 Type: Classroom Training Course

Dates and Locations

Description

Validation for the biotechnology industry is substantially different from that of traditional pharmaceutical manufacturing, because of the complexity and inherent uncertainty of using living organisms as production systems to manufacture complex, biologically active proteins. Uncontrolled and untested changes in the manufacturing process, including both known and unknown raw materials, can impact the activity and antigenicity of the protein by inducing subtle changes in its structure or conformation. Therefore, controlling the manufacturing process using well-defined operating parameters and raw materials is critical to assuring the safety, potency and consistency of the product. Process validation provides a critical mechanism for understanding and controlling these vital manufacturing parameters.

This course provides an overview of the validation effort as applied to clinical and commercial biotechology manufacturing. Topics include the general approach to validation; a review of important biotechnology manufacturing processes, and the strategies and requirements for their validation. Specific topics include validation of buffer/media preparation systems, upstream processes such as fermentation and cell culture, and downstream processes such as centrugation, filtration, and chromatography. Other topics include: master plan development and execution, cleaning validation, analytical methods requirements, protocol writing and execution, and handling of deviations.

In addition to the classroom lecture, participants will take part in several interactive exercises and discussions that allow application of learned content to a typical biotechnology manufacturing process. Participants should have a basic understanding of commissioning, qualification and validation, and also at least a basic familiarity with biotechnology manufacturing processes and unit operations.

Webinar Learning Objectives

• Appreciate the importance of process validation for managing the uncertainties and reducing the “paranoia factor” in biotechnology manufacturing 
• Be grounded in the basic concepts of process validation that will be explored in detail in the classroom course

Take Back to Your Job

• Define key validation activities for biotechnology pharmaceutical manufacturing
• Develop and execute validation master plans and validation protocols
• Discuss validation documentation requirements
• Apply strategies and fundamental components of cleaning validation, media and buffer preparation validation, and process validation for upstream and downstream clinical and commercial manufacturing processes
• Understand requirements for analytical methods used for validation
• Describe how deviations are handled

Attendance Suggested For

• Process development engineers, validation personnel, manufacturing supervisors and managers, quality assurance specialists, and management personnel.
• Other professionals with commissioning, qualification, and validation experience who need a fundamental understanding of process validation for biotechnology manufacturing.
• This training course is of particular interest to existing and future members of the ISPE Biotechnology Community of Practice (COP).

Includes Webinar

This course includes a pre-recorded Webinar that provides a review of the basics prior to the classroom course. You will receive information via email on how to access the Webinar two weeks prior to the start of the training event.

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 mailed within four weeks of evaluation materials. One hour of education programming equals 0.1 ISPE CEU credits.