Program Objectives

By the completion of this program, participants will be able to:

• Interpret and apply global regulatory requirements from the FDA, EMA, and Health Canada for CGT product manufacturing with strategic foresight
• Design chemistry, manufacturing, and control strategies that satisfy multiple jurisdictional expectations simultaneously
• Evaluate manufacturing changes and execute comparability assessments that withstand regulatory scrutiny across regions
• Mitigate risks associated with human and animal-derived materials in CGT manufacturing processes
• Lead organizational compliance efforts for investigational and commercial CGT products through evidence-based decision-making
• Understand the complete manufacturing workflow from raw material sourcing to final product release
• Implement quality systems that address the unique challenges of living cell and gene-based products
• Oversee facility design and utility systems for aseptic processing
• Establish robust environmental monitoring programs for cleanroom facilities

Program Scope

This program encompasses the full spectrum of regulatory requirements and manufacturing processes governing cell-based products, gene therapy products, and genetically modified cell products.

Regulatory Framework Coverage

• Investigational New Drug application requirements for CMC information
• Donor screening, testing, and eligibility determination for cellular starting materials
• Cell banking systems, including master cell banks and working cell banks
• Viral vector manufacturing and control strategies
• Adventitious agent safety evaluation for human and animal-derived materials
• Quality control testing, including sterility, mycoplasma, and replication-competent virus testing
• Stability studies and expiry dating for cellular and gene therapy products
• Comparability assessments following manufacturing process changes
• Quality assurance systems and risk management frameworks
• Environmental risk assessment for genetically modified organisms

Manufacturing Process Coverage

• Raw material selection and qualification
• Cell isolation and expansion techniques
• Genetic modification methods, including viral and non-viral approaches
• Genome editing technologies and their manufacturing implications
• Purification and formulation strategies
• Fill finish operations for cellular products
• Cryopreservation and storage systems
• Transportation and logistics for temperature-sensitive products
• Supply chain management for autologous and allogeneic products

Facilities and Utilities Coverage

• Cleanroom design principles for CGT manufacturing
• HVAC systems and air classification requirements
• Environmental monitoring programs and strategies
• Utility systems, including water, gases, and steam
• Equipment qualification and maintenance programs
• Facility segregation strategies for multiple products
• Cleaning and disinfection programs
• Containment strategies for viral vectors
• Cold chain infrastructure requirements

Target Audience

This program is designed for:

• Regulatory Affairs Directors and Senior Managers in biotechnology and pharmaceutical organizations
• Quality Assurance Executives overseeing CGT manufacturing operations
• CMC Team Leads and Technical Operations Directors
• Compliance Officers specializing in biologics and advanced therapies
• Clinical Development Leaders managing gene therapy and cell therapy programs
• Government Regulatory Officials involved in CGT product evaluation
• Legal and Compliance Professionals supporting CGT product development
• Manufacturing Operations Leaders establishing CGT production facilities
• Facilities and Engineering Directors responsible for GMP cleanrooms
• Supply Chain Executives managing cold chain logistics

Certification

Learners who successfully complete the program will receive a dated, traceable certificate that provides verifiable proof of their achievement for professional records.