Past event: CMO Quality Oversight & Risk Management Summit

Most life science companies are partnering with external organizations that have specialized expertise to develop and manufacture their products in an effort to streamline operations. As with any partnership, there is risk and uncertainty that comes into play when utilizing a contract manufacturing organization.

Sponsors are continually looking for new and efficient ways of managing risk and ensuring the best quality standards. CMO selection is another process that is continuously improved and reevaluated based on the marketplace and a sponsor's need for production. It is critical to assess potential vendors before signing a contract and beginning a partnership.

The 9th CMO Quality Oversight & Risk Management Summit will optimize the collaboration between sponsors and vendors by addressing the most pressing topics including data integrity, quality systems, relationship management, risk management and more.

Conference Highlights

• Three Main Focus Areas: Expert speakers will discuss an array of topics focused on risk management, stakeholder relationship, and quality oversight.
• "Lessons Learned" Series: These sessions will provide a fresh take on case studies, offering attendees real stories and the outcomes from experts who played significant roles in these projects.
• CMO Showcase: An invaluable opportunity for sponsors to get their most pressing questions answered while CMOs and CDMOs present the scope of their resources by detailing their facilities, capabilities, services, and software to pharma and biotech's key decision makers.
• Panel Discussions: We've expanded the program to feature two panel discussions, analyzing outsourcing models, and improving vendor relationships, in order to increase touchpoints between the speakers and audience members
• Benchmark Your Organization: Discuss critical challenges and best practices with the expert speaking faculty as well as your peers.
• Networking: This conference is tri-located with our Technology Transfer for Biologic and Stability Testing Conferences. You and your team will have the opportunity to meet speakers and attendees from all three events.

Who Should Attend

This conference is designed for professionals from pharmaceutical, biotech and medical device companies and CMOs with responsibilities in the following areas:

• Quality Assurance/Quality
• Quality Compliance
• External/Contract Manufacturing
• Regulatory Affairs/Compliance
• Manufacturing Operations
• CMO Oversight
• Product/Device Management
• Technology Transfer
• Supply Chain Management
• Supplier Management
• External Supply/Supplier Quality
• Technical Operations/Development
• Contract Manufacturing Operations
• Outsourcing/Strategic Sourcing
• Process Development/Optimization
• CMC Operations/Chemical Development
• Procurement
• Risk Management
• Biologics
• API Development
• Tech Development
• Supply Operations
• Continuous Manufacturing
• Commercial Manufacturing
• Alliance Management
• Validation

This event is also of interest to:

• Pharma Contract Manufacturing Service Providers
• CMO Auditing Software Organizations
• Regulatory/Compliance Consultants
• Vendor Selection/Management Software
• Compliance Software Companies
• Quality Manufacturing Service Providers

Speakers

• Scott Duncan, Director of CMC, CENTREXION THERAPEUTICS
• Amnon Eylath, President, BROAD SPECTRUM GXP COMPLIANCE
• Rosemary Gibson, Author of "China Rx," Senior Advisor, THE HASTINGS CENTER
• Heidi Hoffmann, Executive Director, CMC and Supply Chain, SUTRO BIOPHARMA
• Li-Chung Huang, Executive Director, CMC Management, WUXI BIOLOGICS
• Gerd Kochendoerfer, Senior Vice President, Head of Operations, PELLEPHARM
• Ben Locwin, Ph.D., MBA, M.S., Senior Vice President of Quality, LUMICELL
• Jayet Moon, Quality Engineering Lead, TERUMO MEDICAL CORPORATION
• Terry Novak, Chief Operating Officer, TEDOR PHARMA
• Naymisha Patel, Vice President, Quality, OCULAR THERAPEUTIX
• Jonathan Patroni, Global Head of Quality Assurance, KYOWA KIRIN BIO-PHARMACEUTICALS
• Adnan Sabir, Principal Consultant, Pharma Consulting Services, Former Associate Director of QA, KOWA PHARMACEUTICALS
• Eyad Salman, Principal Quality Site Manager, GENENTECH
• Jim Stahl, Senior Director of Analytical Development, PROMEDIOR
• Lisa Wyman, Vice President, Quality, ACCELERON PHARMA

Venue

Hyatt Regency Boston Harbor
101 Harborside Dr, 02128
Boston, MA, USA

Venue

Hyatt Regency Boston Harbor
101 Harborside Drive
Boston, MA 02128

To make reservations, please call 1-888-421-1442 and request the negotiated rate for ExL's September Meetings. To make reservations online Click Here

The group rate is available until September 3, 2019. Please book your room early, as rooms available at this rate are limited.