Fundamentals of Good Manufacturing Practices for Biopharmaceuticals

COURSE DESCRIPTION

This course provides a comprehensive overview of the current Good Manufacturing Practices (cGMPs) for producing safe and effective Biopharmaceuticals. Participants will gain an understanding of the regulatory requirements and industry practices necessary for the manufacturing, development, and licensing of Biopharmaceuticals, including methods and requirements. The course also covers emerging trends and risk management strategies for ensuring Biopharmaceutical quality and safety.

■ Understand Biopharmaceutical manufacturing processes and licensing requirements

■ Learn methods and requirements for maintaining Biopharmaceutical quality and safety

■ Discover risk management strategies for ensuring Biopharmaceutical quality and safety

■ Gain insights into supply chain and supplier management, including required support systems

■ Introduction, Expectations and Course Overview

■ Module 1: Biopharmaceutical Production Methods and Regulatory Considerations

■ Module 2: Regulatory Authorities for Drugs, Biologics, and Medical Devices

■ Module 3: Biopharmaceutical Regulations for Drugs, Biologics, and Medical Devices

■ Module 4: cGMPs for Biopharmaceuticals

■ Module 5: ICH Quality Guidelines, Standards and Definitions

■ Module 6: Emerging Trends and Regulatory Initiatives for Biopharmaceuticals

■ Module 7: Drug Development and Regulatory Approval Process

■ Module 8: Product Lifecycle and Quality Culture

■ Module 9: Risk Management and Regulatory Enforcement

■ Module 10: Supply Chain and Supplier Management

■ Wrap up and Certification Exam

The course 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 biopharmaceutical manufacturing. 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.