In this basic-level course, participants will explore the history of the biotechnology industry and will learn the fundamental concepts of biotechnology science. Participants will also learn basic terminology and how it is applied in the industry. The course will identify basic process science and unit operations for the manufacture of products and will describe the regulatory foundation that makes biological products different from traditional pharmaceutical products. There will also be discussions to evaluate emerging technologies and how they will impact the industry. The course will also classify validation issues surrounding compliance with GMP and define basic requirements for facilities that manufacture biological products.
It is a fact of life that even the best designed, equipped and managed pharmaceutical facility will, at some time, experience a microbiological challenge. This could compromise the integrity of a product, threaten the health of a consumer and seriously damage the reputation of the manufacturer. Indeed the most frequent cause of regulatory censure, product recall and loss of production time is that of microbiological contamination.
This course is designed to provide an easily understood, yet comprehensive coverage of the science of microbiology as it might impact a wide range of professionals who have defined responsibilities for product integrity but may lack microbiological awareness.
Commencing with an introduction to the science, the course addresses the behaviour of various organisms, their threat to products, processes and human health and the manner in which they can be identified and controlled. Attention is given to the tests and controls applied to raw materials, active pharmaceutical ingredients, water, and finished products (sterile, non-sterile, inhalation and biologicals). Coverage is also given to the monitoring provided to protect the various production processes from microbiological contamination.
Laboratory facility design is included, while the involvement of microbiology in regulatory inspections is reviewed in detail with expert advice provided regarding the preparation for and management of both a European and American inspection.
This course is intended for industry professionals including production personnel, engineers, auditors; validation scientists; technical support personnel, regulatory/registration executives and even directors who require a basic understanding of the microbiology associated with modern pharmaceutical product design, manufacturing and product release. In addition, staff who are new to working in quality assurance and quality control will also benefit from learning what to expect and how to prevent problems.
This course is recommended for personnel with less than two years of experience in the microbiology field who wish to obtain an understanding of the subject, which will enable them to work more effectively with the microbiology department and to be able to understand and interpret results obtained in their working environment.
