7th CMO Quality Oversight & Risk Management Summit - Boston, MA

7th CMO Quality Oversight & Risk Management Summit
April 24 - 25, 2017
Boston, MA
Boston, MA

Foster a Culture of Quality with CMOs and CGMP in Accordance with Regulations and Best Safety Practices for Pharmaceutical and Combination Products

7th CMO Quality Oversight & Risk Management Summit – 7th CMO Quality Oversight & Risk Management Summit

We are excited to announce that Paula Katz from the FDA is confirmed to speak at this year’s summit!

Paula Katz

Director of Manufacturing Quality Guidance and Policy, Office of Compliance, CDER

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

  1. Ensure data integrity through the responsible management of data and strategic contracts with CMO partners
  2. Turn the requirement of metrics reporting into a competitive advantage while continuing to meet regulatory expectations
  3. Streamline procedures for monitoring process performance and enhancing the quality of a drug or a combination product
  4. Anticipate and mitigate risks to patients, operations and your supply chain through preemptive detection, product oversight and good governance practices
  5. 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:

  • Quality Assurance/Quality
  • External/Contract Manufacturing
  • Regulatory Affairs/Compliance
  • Alliance Management
  • Manufacturing Operations
  • Risk Management
  • Process Development/Optimization
  • Product/Device Management
  • External Supply/Supplier Quality
  • Outsourcing/Strategic Sourcing
  • CMC Operations/Chemical Development
  • Operational Excellence
  • Outsourcing/Sourcing
  • Procurement
  • Supply Chain Management
  • Biologics
  • API Development
  • Technology Transfer

This conference is also of interest to:

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