Biotechnology Basics (T18)

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Level: Fundamental
ISPE CEUs: 1.5
Includes Webinar

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

Description

This course is also available as an online training course. Biotechnology Basics course.

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 one week 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 and European courses. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be available for download in your ISPE account within four weeks of the completion of training. Instruction for download will be sent when the CEUs are available. One hour of education programming equals 0.1 ISPE CEU credits.

Last Update: 25 February 2014

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