Overview

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 training 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

Learning Objectives

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

Who should attend…?

• 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

Course Contents

Day 1

• Biotechnology – The Science
• Bioprocess Basics

Day 2

• Other Manufacturing Techniques
• The Biotech Industry Today

Day 3

• The GMPs
• Regulatory Review

Day 4

• Understanding Biotech Facility Design
• Facility Attributes

Day 5

• Defining the Biotech Project
• Industry Trends and Issues