Ensuring the Quality Connection With Your CMO Through Risk Management

Join ValSource Senior Consultants Jim Vesper, Igor Gorsky, and Hal Baseman as they team with FDANews to present a hands-on, interactive training course on

Ensuring the Quality Connection With Your CMO Through Risk Management
June 13-14 | Philadelphia, PA


The course is designed to help companies using or planning to use contract manufacturing organizations (CMOs) optimize the effectiveness of their outsourcing by creating effective CMO/Client relationships, anticipating unique manufacturing needs, developing workable quality agreements, and risk based addressing of manufacturing and quality challenges.

While there are definite advantages to working with a CMO, there are also risks that need to be understood and controlled so beneficial outcomes result for all parties, including the patients and consumers.  The workshop examines CMO relationships and activities using a risk-based lifecycle model that each participant can adapt for their own use and situation.

Who Should Attend

This is an important event for quality unit leaders, product development, quality auditors, procurement specialists, business development personnel, technical services, and those responsible for external business as well as CMO professionals responsible for work with product owners. CMO/Sponsor case studies, based on recent FDA Warning Letters and the facilitator’s experiences (in both sides of the CMO world) will use facilitated risk models so participants develop a quality systems-based understanding of risks that can occur and ways to reduce such risks.

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