8th CMO Quality Oversight & Risk Management Summit - Boston, MA

8th CMO Quality Oversight & Risk Management Summit
March 21–22, 2018
Boston, MA
Boston, MA

Ensuring Compliance and Robust Partnerships Through Rigorous Discourse and Disseminations of Tactical Operations, Oversight and Quality Systems

8th CMO Quality Oversight & Risk Management Summit – 8th CMO Quality Oversight & Risk Management Summit

CONFERENCE UPDATE: All conferences are being conducted as scheduled. We are aware there is a chance of inclement weather. We will update all participants if there are any changes made.

Announcement: We are proud to welcome Paula Katz from the FDA to this year’s program!

Featured Speakers

The 8th 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.

This industry-leading event stands alone in its design and executions of sessions that optimize partnerships between sponsors and CMOs by promoting the dissemination and development of best practices related to quality oversight and risk management.

Participants from leading medical device and pharmaceutical companies and from forward-thinking CMOs consistently return for the dependable vital information, professional development that accompanies the presentation of replicable best practices and tools.

The panel discussions, case studies, networking and general interactive environment that this event is known for engendering collegiality that elicits open and constructive dialogue around lessons learned between and among industry peers.

A mutual understanding of the risk involved for each project and a transparent working relationship are key prerequisites for a successful client/CMO partnerships. This conference offers a toolkit to prevent GMP failures that would result in adverse events/product recalls.

Executive Summary

Download our Executive Summary which highlights presentations and stats from last year’s program


  • “World-class presentations from senior leaders. Really worthwhile to attend and will encourage my staff to attend next year.”

    —QA Director, Genzyme External Manufacturing, SANOFI BIOLOGICS

  • “Great topics, experienced leaders, no ‘redundant’ presentations on same subject matter.”

    —Brid Rooney, QA Director, SANOFI BIOLOGICS

  • “Excellent group size. Experienced attendees.”

    —Cameron Jones, QA Director, BRAMMER BIO

  • “All talks were relevant to my role and I gleaned a few items to consider/discuss with my team from each speaker. FDA speaker +++”

    —Nuha Al-Hafez, Head, External Supply Quality Group, MERCK

  • “Can’t wait to apply lessons learned in CMO Quality Management. Extremely valuable content relevant across drug and therapeutic manufacturing platforms.”

    —Michael Gargiulo, Quality Manager, External Manufacturing, VALEANT

  • “This conference has provided me with useful tools and different perspectives that will allow me to successfully transfer drug products.”

    —Nicole Zinzi, Manufacturing Process and Technology Associate, REGENERON

Top Five Reasons to Attend

  1. Ensure data integrity through judicious selection, contracting and governance
  2. Effect technology and method transfer and assess success with KPI’s and by co-opting tools and metrics
  3. Comply with the latest and pending regulations critical measures in accordance with inspection trends
  4. Streamline operations and procedures for oversight and risk management for drug or a combination product
  5. Anticipate and mitigate risk through prevention and preemptive detection

Who Should Attend

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

  • Quality Assurance/Quality
  • External/Contract Manufacturing
  • Regulatory Affairs/Compliance
  • Manufacturing Operations
  • Product/Device Management
  • Technology Transfer
  • Supply Chain 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

The 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
End Date

Address : 8th CMO Quality Oversight and Risk Management Summit

live chat software