Biotechnology Basics (T18)

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Training

Level: Fundamental
ISPE CEUs: 1.5
Includes Webinar

Date	Location	Country	Instructor(s)
This course is not currently scheduled, but may be conducted at your company. Please contact ISPE for more information.

Description

This fundamental course is ideal for professionals that are new to the biotechnology industry, professionals entering new work assignments encompassing biotechnology operations, or individuals with previous pharmaceutical industry experience that want to learn the basics of biotechnology. This is a course that is ideal for individuals involved in human resources, economic development, and business and strategic planning efforts. Professionals in quality control, quality assurance, and technical management support will also find it beneficial.

Participants in this course 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 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.

The course will present information on:

The history of the biotechnology industry
The science behind the industry
Products
Application of technology
Process unit operations
Regulatory aspects
Facilities and equipment
Industry trends and issues

Course Modules

Biotechnology - The Science
Bioprocess Basics
Other Manufacturing Techniques
The Biotech Industry Today
The GMPs
Regulatory Review
Understanding Biotech Facility Design
Facility Attributes
Defining the Biotech Project
Industry Trends and Issues

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.

Webinar Learning Objectives

Describe biological products and manufacturing processes
Explain regulatory philosophy
Discuss facility design concepts within the biotechnology industry

Take Back to Your Job

Describe the history of the biotechnology industry
Cite fundamental concepts of biotechnology science
Utilize basic terminology
Identify basic process science and unit operations for the manufacture of products
Describe the regulatory foundation that makes biological products different from traditional pharmaceutical products
Evaluate emerging technologies and how they will impact the industry
Classify validation issues surrounding compliance with GMP
Define basic requirements for facilities that manufacture biological products
Identify alternatives in design of manufacturing facilities that address GMP issues
Describe growth of the industry and issues that will impact its future

Attendance Suggested For

Professionals who are new to the biotechnology industry
Professionals entering new work assignments encompassing biotechnology operations
Individuals with previous pharmaceutical industry experience wanting to learn the basics of biotechnology
Individuals involved in economic development, human resources, and business and strategic planning efforts which involve current or potential biological production services clients
Quality control, quality assurance, technical support, and management personnel

Community of Practice (COP)

This training course is of particular interest to existing and future members of the ISPE Biotechnology Community of Practice (COP).

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

Last Update: 13 February 2013