Quality Basics for Cell and Gene Therapy Products

About this course

Learning objectives

Module 1: Overview of FDA and the Regulatory Framework

• Identify the different centers within FDA and their regulatory scope
• Recall the regulations and guidance’s applicable to GQR
• Recognize and appreciate tools (inspections and enforcement) in FDA to maintain compliance to regulations

Module 2: GMP and Quality Systems

• Summarize the GMP principles
• Summarize the Quality Systems approach
• Describe how the GMP principles and Quality Systems approach work together to consistently produce a high quality product that is safe and efficacious

Module 3: Standards

• Summarize the role of Pharmacopeias, ICH guidelines, ISO and ASTM standards in GQR
• Describe and develop the standard (s) that will be appropriate for use in cell and gene therapy product manufacturing

Module 4: Controls

• Understand and explain the importance of control on sourcing for raw materials, cell banks, cell-line etc. and qualification of suppliers and CRO’s
• Learn about production and process controls, critical quality attributes, SOPs, batch records and validation protocols
• Develop an appreciation for the sterilization and aseptic process validation methodologies
• Describe Quality Control and Quality Assurance process

Module 5: Risk Management

• Recognize the components of the Risk Management paradigm
• Understand and describe the strategies used in Risk Management
• Delineate the Risk Management Strategies applicable to cell and gene therapy product manufacturing

Module 6: Emerging Technology (e.g., MSC manufacturing)

• Describe the Challenges in cell and gene therapy product manufacturing under GMP
• Explain how GQR principles can facilitate the emerging technology development

Who should attend?

This is a foundational course for anyone planning for a job in cell and gene therapy manufacturing, including Research and Development. This course will provide the basic training needed to develop quality cell and gene therapy products.