Risk Management in Technology Transfer - Training / Workshop von PDA Europe gGmbH

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.

• 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