6th CMO Quality Oversight and Risk Management Summit - Boston, MA

6th CMO Quality Oversight and Risk Management Summit
April 20 - 21, 2016
Boston, MA
Boston, MA

Strategic Insights on Drug Development to a Contract Manufacturing Organization in an Evolving Regulatory Landscape

6th CMO Quality Oversight & Risk Management Summit – 6th CMO Quality Oversight and Risk Management Summit

The use of contract manufacturing organizations (CMOs) in the life science industry has been growing at a rapid pace over the past decade, and the trend is projected to continue across all industry sectors, including pharmaceutical, biotech and medical device. As industry leaders continue to turn to external partners at a rapid rate, experts predict that the global CMO market value will exceed $60 billion by 2018. Thus, effective quality oversight and risk management have become more essential than ever when ensuring successful partnerships, GMP compliance and a lucrative completion of the product’s outsourced manufacturing supply chain.

The 6th CMO Quality Oversight & Risk Management Summit brings together industry innovators to connect and discuss the latest outsourcing trends and hot button issues in pharmaceutical, biotechnology and medical device contract manufacturing.

The conference is designed to optimize partnerships between sponsors and CMOs while serving as a networking platform and offering professionals vital information on how to strategically navigate the outsourcing and quality oversight of CMOs in an evolving regulatory landscape. Additionally, this event offers vigorous tactics to track and prevent GMP failures, ultimately preventing product recalls and other adverse events.

A mutual understanding of risk involved for each project and a transparent working relationship are both key prerequisites for a successful client/CMO partnership. This conference will offer a unique tool kit to help design the right manufacturing and development program, establish a sense of co-ownership and responsibility for the CMO and client, execute a unified contract, and identify roles and responsibilities for each member of a project.

Additional topics will include: best practices to effectively oversee and manage external manufacturers, tips on utilizing Big Data analytics to improve CMO results, the newest FDA policies and their impact on CMO partnerships, effective risk management strategies for pharma companies and CMOs, the latest outsourcing trends, and strategies for creative contracting.

You asked for content specifically addressing the topics below and we are thrilled to provide you with unique case studies, panels and interactive sessions on:

  • Drafting creative contracts and quality agreements that incentivize CMOs
  • Understanding the CMO’s perspective and implementing an effective internal CMO management structure
  • Streamlining procedures for monitoring process performance and product quality
  • Identifying the right supplier for emerging, niche or startup companies
  • The latest federal policies and their impact on outsourcing

Top Five Reasons to Attend

  • Learn how to use Big Data analytics to improve CMO results; get up to date on the latest FDA policies and their impact on CMO partnerships
  • Master how to identify individual risks and their effect on a project when considering outsourcing; reduce risks to patients, operations and supply chains through preemptive detection and product oversight
  • Cultivate smart guidelines for collaborating with external vendors in the Asian market
  • Discover the latest outsourcing trends among oncology drug developers and biomanufacturing companies
  • Identify the right supplier for emerging, niche or startup companies

Who Should Attend

This conference is specifically designed for professionals from multi-sized CMOs and pharmaceutical, biotech and medical device companies specializing in:

  • Quality Assurance
  • R&D Quality Management
  • Manufacturing Compliance/GMP/Operating
  • External Manufacturing/Contract Manufacturing
  • Product Quality/Development
  • External/Supplier Quality
  • Training and Development
  • Strategic Outsourcing
  • Chemical Development
  • External Quality
  • Auditing
  • Risk Management
  • Regulatory Affairs/Compliance
  • Technology Transfer
  • Process Development/Optimization
  • Outsourcing/Strategic Sourcing
  • Supply Chain
  • Operational Excellence
  • Strategic Sourcing
  • API Development
  • Biologics
  • Technology Transfer

This conference is also of interest to:

  • Quality Manufacturing Service Providers
  • CMO Auditing Software Companies
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