cGMP and Quality Issues for Biopharmaceuticals
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This course is available as a client site course. Please click here for more information.
Who Should Attend
This is a course designed for those individuals responsible
for implementing and maintaining a manufacturing process
or processes which are compliant with the regulations and
guidelines of national and international regulatory
organizations. Specific functions within a biotechnology
organization which would benefit from this course include
Quality Assurance, Quality Control, Manufacturing,
Technology Transfer, Product Development, Research and
Development. The information presented is cutting edge
and will benefit established organizations that wish to stay
in compliance with changing global regulatory
requirements.
Description
This course is intended to introduce the participant to the
concept of risk-based development and maintenance of
cGMP manufacturing processes. Science-based concepts
will be used for prospective validation of a manufacturing
process based on critical process analysis and critical
process control. Factor influencing decisions concerning
the implementation of cGMP during product development
will be discussed. The importance of process analytical
technologies and statistical process control in cGMP
manufacturing will be emphasized.
Attend this course and its companion course, Assay Development and Validation for Biopharmaceuticals, ID #1933 (Session #05D1933-272) and save $400 off the combined tuition.