We are excited to announce that Paula Katz from the FDA is confirmed to speak at this year’s summit!
Director of Manufacturing Quality Guidance and Policy, Office of Compliance, CDER FDA
The 7th CMO Quality Oversight & Risk Management Summit brings together industry leaders to discuss the latest outsourcing trends and developments in pharmaceutical, biotechnology and medical device contract manufacturing. The conference is designed to optimize partnerships between sponsors and CMOs by promoting the dissemination and development of best practices related to quality oversight and risk management.
The conference continues to be the gold standard for participants seeking proven strategies and vital information to navigate the outsourcing and quality oversight of CMOs.
This event convenes leaders from CMOs and sponsors for unparalleled panel discussions, networking, collegial dialogue and plenary sessions. A mutual understanding of risk involved for each project and a transparent working relationship are key prerequisites for a successful client/CMO partnership. This conference offers a toolkit to:
Prevent GMP failures that would result in adverse events/product recalls
Design the right manufacturing and development program
Establish a sense of co-ownership and responsibility for the CMO and client
Execute a unified contract
Identify roles and responsibilities for each member of a project
Top Five Reasons to Attend
Ensure data integrity through the responsible management of data and strategic contracts with CMO partners
Turn the requirement of metrics reporting into a competitive advantage while continuing to meet regulatory expectations
Streamline procedures for monitoring process performance and enhancing the quality of a drug or a combination product
Anticipate and mitigate risks to patients, operations and your supply chain through preemptive detection, product oversight and good governance practices
Adopt and use objective measures and subjective criteria to assess the capability and suitability of CMOs and partners of different sizes and cultures
Who Should Attend
This conference is designed for professionals from CMOs and pharmaceutical, biotech, medical device companies with responsibilities in the following areas: