Implementation of Single-Use Technology in Biopharmaceutical Production

COURSE DESCRIPTION

This interactive 30-hour course provides an introduction to single-use systems (SUS) in the biopharmaceutical industry, covering methods, requirements, and emerging trends in licensed biopharmaceutical therapeutics. Participants will gain a solid understanding of current good manufacturing practice (cGMP) guidelines, SUS application, and different types of SUS. The course will explore the fundamentals of biopharmaceutical production and provide attendees with the knowledge necessary to produce human therapeutics.

■ Understand the production processes involved in the biopharmaceutical industry and how Single-Use Systems (SUS) are applied to the production process

■ Evaluate the advantages of Single-Use Technology (SUT) and their impact on biopharmaceutical production

■ Identify various types of SUS, their associated requirements and their application in biopharmaceutical processes

■ Introduction, Expectations and Course Overview

■ Module 1: Industry Review: Production Methods and Single-Use

■ Module 2: Advantages of Single-Use Technology

■ Module 3: Materials of construction and manufacturing methods

■ Module 4: Requirements for Single-Use Systems

■ Module 5: Types of Single-Use Equipment

■ Module 6: Single-Use Equipment Assemblies

■ Module 7: Single-Use Sterilization and Risk Management

■ Module 8: Single-Use Product Lifecycle

■ Module 9: Supply Chain and Supplier Management

■ Module 10: Emerging Trends in Single-Use Technology

■ Wrap up and Certification Exam

The course provides a solid foundation in the basics of single-use systems and is designed for individuals interested in entering the field of biopharmaceutical manufacturing, or those who are already working in the industry requiring a solid foundation in the basics, including those working in manufacturing roles, regulatory affairs, quality control, research and development. This includes process engineers, manufacturing technicians, quality assurance professionals, regulatory affairs staff, scientists, project managers and executives. The course is also ideal for recent graduates who have an interest in biotechnology or life sciences, as well as professionals who are looking to expand their knowledge and skills in single use systems. By the end of the course, you will have acquired the skills and knowledge necessary to advance your career in this rapidly growing and dynamic field.

The course will utilize a range of assessment methods to evaluate your understanding of the material. These may include quizzes, online reviews, both group-based and online discussions and presentations. These methods will allow you to demonstrate your knowledge, interact with other students and the instructor, and receive constructive feedback on your progress throughout the course.

The course has been developed following the rigorous standards for content development and instructional design of Barnett International’s third-party accreditation provider. Thirty hours of formal continuing education units are provided. Additionally, the course is also one of three components of the Professional Biopharmaceutical Certification Program, and therefore qualifies toward one of three badges required to achieve full certification.