Microbiology for Technical Professionals - Fundamentals

ISPE CEUs*: 1.3
Type: Classroom Training Course

Description

In this fundamental 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 behavior 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 and management for both a European and American inspection.

Take Back to Your Job

• Identify the main groups of microorganisms and know how to count them
• Understand the conditions which encourage microbial growth together with identifying methods of killing microorganisms
• Identify how microbes affect typical pharmaceutical production processes
• Know how to monitor areas and protect product from contamination
• Understand the application of the major pharmaceutical testing methodologies and how to apply them in in-process control, batch release and stability evaluation
• Understand the rationale for a microbiological laboratory design
• Know how to prepare for an FDA inspection with regard to microbiological data

Attendance Suggested For

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.

Student Success Story: Eric Blaesing, Scientist I, Wyeth Vaccines 

"It was while walking down the hall in the science building at Campbell University when I first heard about ISPE though I wasn’t really familiar with what it all had to offer. A flyer was attached to a bulletin board advertising free pizza and extra credit for students majoring in pharmaceutical sciences, and as the case with any college student I was there. Little did I know at the time how ISPE would soon change my life and point me down a career path of success.

"To be honest, I can’t even remember who the speaker was that night or the topic that was spoken on at that meeting, but towards the end of the presentation, the speaker shifted gears and began describing the vast number of benefits of being a member of ISPE as a student. Needless to say, I was mesmerized by what all ISPE had to offer a student within its organization so that night I joined.

"A few months went by and the newness of getting free pizza and extra credit to attend the ISPE student chapter meetings was beginning to wear away, and I was becoming bored. Looking back now, I can pinpoint the reason to my boredom to the fact that I was not involved. I was merely a benchwarmer filling a seat in an auditorium. It wasn’t until one night when I was working in the hardware department at Wal-Mart that I bumped into Mark Yates, an industry member in ISPE, and began talking with him about school and ISPE. Funny enough Mark was also my college advisor my freshman year before he left the world of academia to work in the industry. As we were talking, I remember mentioning to him that I had a few credit hours to fill for the upcoming fall semester so I was toying with the idea of getting a minor in chemistry. He immediately responded with the statement that I should consider teaming up with a professor at school and doing some independent research instead and present it at the local ISPE poster competition, as it would help differentiate my resume from others when looking for a job after college. After some thought, I decided to take his advice. In the spring of 2003, I presented my poster at the local CASA meeting and won an all-expense paid trip to the ISPE Annual Meeting in New Orleans in November to present my poster again. I went on to win the Student Poster of the Year for Undergraduate students as well as a cash award.

"Since becoming involved in ISPE, I have taken advantage of the many opportunities to attend many conferences and leadership forums. In doing so, I have met and networked with many professionals that have helped refine my career path, which has enabled me to be successful today. In fact, through different contacts and help from the people I met, Wyeth recruited me for a full-time position before I had even graduated from college. With that being said, I leave this advice. Get involved! Whether it is participating in the poster competition, attending the Leadership Forum in Washington or Annual Meeting, or serving as an officer in a local student chapter, the opportunities are endless! The people you meet and the knowledge you gain along the way can make all the difference in leading to a successful career!"