Risk Management in Technology Transfer

Nowadays technology transfer projects are a reality in the pharma markets. For several reasons, manufacturing process and related activities (i.e. analytical, development, quality, operation excellence) are moved intra companies and inter companies. Due to the high number of risks associated with the safe robust and in compliance manufacturing of a drug, an appropriate risk management approach and appropriate skills have to be in place in the transferring and receiving site. Following the main international guidance, such as technical report 65 and ICH, this workshop will guide the attendees through a technology transfer process and its risk management and provide insights and practical guidance for developing internal robust procedures, skills and approaches.

Who Should Attend

Subject matter experts coming from different areas such as

• Production
• QA
• Validation
• Engineering (involved in process/equipment design)
• RA
• QC (involved in analytical transfer)
• Project Managers and Technology Transfer Managers are key

Learning Objectives

• Understand principles, main documents and main steps of a technology transfer process (internal and external)
• Identify risks in technology transfer processes
• Evaluate risks and put in place appropriate mitigation plan
• Understand main roles and responsibilities of the stakeholders of technology transfer process • Create high level internal procedures for handle technology transfer

Instructor

Mirko Gabriele, Global Technology Transfer Senior Manager, Patheon
Mirko joined Patheon in 2008 and has held various positions, including Technology Transfer Project Manager, Technical Business Manager and Manager of Technology Transfer Responsibility for the Ferentino team. He also has experience in Quality Control and Research and Development, both in Finished Products and API companies. Mirko led the Parenteral Drug Association (PDA) Group issuing the Technical Report 65 on Risk Management during Technology Transfer and is currently leading the PDA Global Technology Transfer Interest Group. He is member of the PDA Regulatory Affairs and Quality Advisory Board since 2014. Mirko received a Master Degree in Chemical and Pharmaceutical Technologies in 2004 at the University of Rome and in 2012 and Executive MBA in Pharma Administration at the Luiss Business School of Rome. Mirko is Qualified Person for the Italian Health Authority since July 2014.