EXPORT-ORIENTED MANAGEMENT - IMC Fachhochschule Krems

Prerequisites / Level
Advanced
Course Description
The course covers the following topics:
� Introduction
� Types of Technical Specifications
� Main content of Ordering Specifications
� Presentations of various specifications by the students followed by
discussions
� Detail engineering of piping and vessels
� IQ, OQ and PQ of process equipment
� Design of biopharmaceutical facilities
Teaching Methods
In the first meeting the flow sheets of various unit operations are shown and elucidated
in detail. Each student (or a small group of students) has to select one type of
equipment displayed in the flow sheets, from which an ordering specification has to be
prepared using sources supplied in the home pages of the main manufacturers of process
equipment. The students are requested to contribute to the particular presentations by
any comments or by putting critical questions.
In order to support the understanding of my own presentations regarding detail
engineering of piping and vessels as well as the qualification of equipment various
drawings and layouts are shown. Some examples in the field of "Piping and
Instrumentation Drawings" are included.
Evaluation
Specification, final exam
Equipment, test and process validation
Semester Hours per week Subject code ECTS
Fall 2 ETPV_T 2
Learning Outcomes/ Course Objectives
On successful completion of the course the students will be able to understand
Qualification and Validation principles including Design Phase, Equipment Qualification,
Analytical Method Validation, Computerized System Validation, Process Validation,
Cleaning and Sterilization Validation as well as regulatory respectively industry
background and expectations
Prerequisites / Level
Advanced
Course Description
The course covers the foundation of validation, regulatory requirements and guidelines,
validation pyramid, equipment qualification (DQ, IQ, OQ, PQ), risk analysis, facility
qualification, method validation (sensitivity, robustness, reproducibility), process
validation, cleaning validation and sterilization/sanitization validation. Workshops will
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