GMP Compliance for Biopharmaceuticals and Cell & Gene Therapy Products

This 60-minute webinar on GMP Compliance for Biopharmaceuticals and Cell & Gene Therapy Products provides a comprehensive overview of regulatory expectations, quality management principles, and industry best practices for ensuring compliance in these highly specialized fields.

Participants will gain insights into the FDA, EMA, and ICH regulatory frameworks, key differences between traditional biopharmaceuticals and advanced therapies, and the unique GMP challenges associated with autologous and allogeneic cell therapies, vector production, and patient-specific manufacturing. The session will cover risk-based quality management approaches, including process validation, aseptic processing, supply chain controls, data integrity, and deviation management. Through real-world case studies and lessons from regulatory inspections, attendees will learn strategies for maintaining compliance and mitigating risks in an evolving regulatory landscape. The webinar will conclude with an interactive Q&A session, offering participants the opportunity to discuss challenges and clarify key concepts with the expert speaker.

Why you should Attend:
Participants should attend this training to gain a comprehensive understanding of GMP compliance specifically tailored to biopharmaceuticals and cell & gene therapy products, which face unique regulatory and manufacturing challenges. As these advanced therapies continue to evolve, companies must navigate complex FDA, EMA, and ICH requirements, ensuring process validation, aseptic processing, and quality control are met while maintaining compliance with evolving regulations.

This webinar will provide practical insights, real-world case studies, and expert guidance on how to effectively implement risk-based quality management systems, address deviation management and CAPA, and prepare for regulatory inspections. Whether you are a quality professional, regulatory affairs specialist, manufacturing leader, or involved in product development, this session will equip you with the knowledge and tools needed to enhance compliance, reduce regulatory risks, and optimize manufacturing processes in this highly specialized industry.

Areas Covered in the Session:

• Introduction
• Welcome and Speaker Introduction
• Overview of Webinar Objectives
• Importance of GMP in Biopharmaceuticals and Cell & Gene Therapy
• Regulatory Landscape and Key Guidelines
• FDA, EMA, and ICH Guidelines for Biopharmaceutical GMP Compliance
• Specific Regulations for Cell & Gene Therapy (e.g., FDA’s CFR 21 Part 1271, ATMP Guidelines)
• Differences Between Traditional Biopharma GMP and Advanced Therapies
• Key GMP Considerations for Biopharmaceuticals
• Facility and Equipment Qualification
• Raw Materials and Supply Chain Controls
• Process Validation and Manufacturing Controls
• Aseptic Processing and Sterility Considerations
• GMP Challenges for Cell & Gene Therapy Products
• Unique Challenges in Autologous vs. Allogeneic Therapies
• Vector Production and Containment Strategies
• Patient-Specific Manufacturing Considerations
• Quality Control, Release Testing, and Stability Challenges
• Quality Management and Risk-Based Approaches
• Risk Management in Advanced Therapy Manufacturing
• Implementing Quality Systems for Compliance
• Documentation, Data Integrity, and Electronic Records
• Deviation Management and CAPA Implementation
• Case Studies and Best Practices
• Real-World Compliance Challenges and Solutions
• Lessons Learned from Regulatory Inspections

• Quality Assurance (QA) Professionals
• Quality Control (QC) Specialists
• Regulatory Affairs Specialists & Managers
• Manufacturing & Production Personnel
• Process Development Scientists & Engineers
• Validation & Compliance Experts
• Clinical & Technical Operations Teams
• Supply Chain & Procurement Specialists
• GMP Training & Documentation Specialists
• Auditors & Inspectors