Description

This comprehensive training program offers an in-depth exploration of the complex and rapidly evolving field of Advanced Therapy Medicinal Product (ATMP) manufacturing. Designed to bridge the gap between scientific innovation and regulatory compliance, the curriculum guides participants through the entire product lifecycle, from foundational science and supply chain logistics to the critical principles of facility and cleanroom design. The program places a strong emphasis on the practical application of Quality Risk Management and Contamination Control Strategies, demonstrating how these concepts must drive decisions in process development, facility layout, and operational workflows. Participants will gain a holistic understanding of the unique challenges posed by living products, including the “batch-of-one” paradigm of autologous cell therapies, the requirements for aseptic processing, and the complexities of vein-to-vein logistics. By integrating theoretical concepts with real-world examples and detailed case studies, this training provides essential knowledge for professionals seeking to design, operate, or support compliant and effective ATMF manufacturing operations.

Global Regulations and Standards Referenced

This training program was designed with reference to the following key global regulations, guidelines, and standards:

European Union Framework:

• Regulation (EC) No 1394/2007 on advanced therapy medicinal products.
• Directive 2001/83/EC on the Community code relating to medicinal products for human use.
• EudraLex, Volume 4, Part IV (GMP for ATMPs).
• EudraLex, Volume 4, Annex 1 (Manufacture of Sterile Medicinal Products).
• EMA guidelines on quality for gene and cell therapy medicinal products.

United States Framework:

• Public Health Service Act (PHSA) Section 351.
• Code of Federal Regulations (CFR) Title 21, Parts 210 & 211 (cGMP).
• Code of Federal Regulations (CFR) Title 21, Part 1271 (Human Cells, Tissues, and Cellular and Tissue-Based Products).
• FDA guidance documents specific to gene therapy, cell therapy, and tissue-engineered products.

International Council for Harmonization (ICH) Guidelines:

• ICH Q7 (GMP for Active Pharmaceutical Ingredients).
• ICH Q8 (Pharmaceutical Development).
• ICH Q9 (Quality Risk Management).
• ICH Q10 (Pharmaceutical Quality Systems).
• ICH Q5A (Viral Safety Evaluation).

International Organization for Standardization (ISO) Standards:

• ISO 14644 series (Cleanrooms and associated controlled environments).

Pharmacopoeias:

• European Pharmacopeia (Ph. Eur.)
• United States Pharmacopeia (USP)

World Health Organization (WHO) Guidelines:

• WHO Guidelines on Good Manufacturing Practices for Biological Products.
• WHO Recommendations for the Production and Control of Gene Therapy Medicinal Products.

Target Audience

This training program is designed for a multi-disciplinary audience of professionals involved in or supporting ATMP development, manufacturing, and quality operations, including:

• Process Development Scientists and Engineers
• Quality Assurance and Quality Control Professionals
• Facility and Plant Engineers responsible for cleanroom design and maintenance.
• Regulatory Affairs Specialists
• Supply Chain and Logistics Managers
• Technical Operations and Manufacturing Leadership
• Clinical Development Professionals
• Academic Researchers transitioning toward clinical development.
• Investors and Business Development Professionals seeking technical literacy.
• Regulatory Inspectors seeking insight into current industry practices.

Certification

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