Technology Transfer of manufacturing and packaging Process

The course sessions are illustrated with examples based on case studies
Opportunities for participants to ask questions and practice their skills.
Practical exercises include examples and discussions

Speaker

Kossi Molley, PMP, LSSBB, Chemist, Certified Trainer

Two-day Technology Transfer Training

Technology transfer of manufacturing processes is a critical aspect of the pharmaceutical industry. Technology transfer (TT) is an increasingly important part of the pharmaceutical industry, with companies expanding the use of third parties for both development and manufacture. There are few formal guidelines around this subject, but regulators expect companies to get it right for both internal and external transfers. Poorly run transfers can be costly and impact product quality, whereas well-run transfers bring business benefits and assure product quality.

Objectives

Attending this highly practical course will give participants the tools to help guide them through achieving successful transfers. It applies to those making transfers from development to commercial, from commercial to commercial, for scale-up, analytical methods, or for ‘virtual’ companies. Specifically, this session will:

Equip trainees with the knowledge and skills to effectively transfer manufacturing and packaging processes from development to full-scale production.
Ensure consistent and high-quality product output by establishing a smooth and efficient technology transfer process.
Minimize risks and delays associated with transitioning from R&D to manufacturing.
Promote clear communication and collaboration between development and production teams.

What You Will Learn

The stages of technology transfer: Understand the different phases involved in transferring a process from development to production (e.g., process definition, documentation, training, validation).
Documentation requirements: Learn how to create clear, concise, and comprehensive documentation for manufacturing and packaging processes, including process flowcharts, standard operating procedures (SOPs), and specifications.
Training and qualification: Gain knowledge on how to effectively train production personnel on the new process, ensuring they understand the procedures and can perform them competently.
Validation and verification: Understand the importance of validating the transferred process to ensure it meets the desired quality standards and performs consistently.
Risk management: Learn strategies to identify and mitigate potential risks associated with technology transfer, such as deviations from specifications or equipment malfunctions.
Communication and collaboration: Develop effective communication and collaboration skills between development and production teams throughout the transfer process.
Regulatory considerations: Gain an understanding of any relevant regulatory requirements that need to be addressed during the technology transfer process.

Who Should Attend

This seminar will be of particular interest to all those from the pharmaceutical industry working in:

Development
Manufacturing
Engineering
Quality
Managers who are likely to sponsor projects.
All other interested personnel from the pharmaceutical and biopharmaceutical industries