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In advance of the 2016 PDA Outsourcing/CMO Conference, on Nov. 2, PDA Education will host the 2016 PDA Outsourcing/CMO Course Series, made up of two full-day courses that will address important topics to consider when outsourcing and/or partnering with a contract manufacturing organization.

Technology Transfer (Nov. 2)

This course will examine various approaches to the technology transfer process and project management considerations for the transfer of large and small molecules. Major topics to be explored include process and analytical transfers, risk management, documentation and knowledge management, and personnel training and skills.

Establishing a Robust Relationship with Your Client/CMO (Nov. 2)

This course will examine the elements of a good working relationship between the contract manufacturing organization (CMO) and the client. Critical areas where the client and the CMO must work cohesively to achieve a desired outcome will be addressed, including drafting quality agreements, collaborating during investigations, determining what information to include in a technology transfer and working together to develop regulatory strategies that may affect the facility or product filing.

PDA is accredited by ACPE and offers continuing education for professional engineers.