Industries: Pharma / BiotechMedical Device

Qualifying, Management and Auditing of Contract Manufacturing Organizations

Course Director: Dr. Steven Ostrove

Course Fee: $2150.00 Regular Registration / $1950.00 Early Bird (30 Days in Advance)  

Course Description - Course runs 9:00 - 5:00 both days (Breakfast & Lunch Included)

This course is designed for those involved in the selection or implementation of a Contract Manufacturing Organization or CMO.  The course is divided into three parts.  Each part is specific for a critical phase of your companies’ selection and use of a CMO.  The first part will present ideas and information necessary for the selection of a CMO. The second part will deal with the actual auditing of the CMO. The third part of this course will cover management of the CMO from the prospective of the company.

Along with selecting, auditing, and managing a CMO it is important to understand the companies’ responsibilities towards using a CMO as well as the CMOs responsibility to the company.

Of course examples will be provided throughout the class in order to bring key ideas into focus Individual/group ‘workshops’ will also be presented throughout the course to help with understanding the topics.  Questions are always welcome and in fact encouraged at all times.

Who Should Attend

This class is designed for those thinking of employing a Contract Manufacturing Organization (CMO) for outsourcing their production.  The course is intended for those involved with selecting and auditing the CMO or as well as those who will manage the CMO program.  Selection of a CMO entails more than ‘can they make your product’.  One needs to understand the concerns of the CMO as related to their clients.  The class will give an overview of the steps necessary for a successful technology transfer and running of an outsourced product via a CMO.

The course is divided into three sections.  The first section discusses how to select a CMO.  Size, technical expertise, location, quality systems and more will be discussed.  The second section discusses the actual auditing process.  What to ask, how to ask the correct questions and setting up an effective auditing program are the key takeaway ideas of this section.  The third section deals with managing the CMO after you have selected the organization.  Writing the quality agreement, auditing the work in progress, scheduling, and more will be discussed.

Functions that will benefit from this course are Quality (auditing, batch record review), Sales, Marketing (production output, metrics), Management, and Operations (raw materials, speed of production).  Of course, others will also benefit if even only indirectly involved with the CMO.  Functions such as development will have input into selection (technology transfer) and oversight of the CMOs qualifications and GMP compliance (regulatory and Validation groups).  QC laboratory personnel etc. are also an important part of the successful selection and management of a CMO.

Course Agenda

Selecting a CMO

  • Outsourcing Strategies
  • Regulatory Considerations
  • Finding the Right Contractor/Supplier
  • Contracts/Agreements; RFP’s
  • Supplier Quality Categories
  • Current CMO/Outsourcing Issues
  • Phases of CMO Selection
  • Decision Factors for Selecting a CMO-Key Practical Points
  • Distinctive Technical Competence
  • CMO Size

Auditing a Prospective CMO

  • Planning a Qualification Audit-Establishing Evaluation Team
  • CMO Management Principles
  • Supplier Auditing Overview/Supplier
  • Distinctive Technical Competence
  • Conducting a Qualification Audit-Key Points to Evaluate
  • Suppliers/Vendors Approval Process
  • Facility Walkthrough (Material Flow)
  • Quality Systems (Change Control, etc.)
  • Risk Management

CMO Management

  • CMO/Supplier & Material
  • Supplier Monitoring
  • Outsourcing Project Planning
  • Approved Vendor List
  • Key Points for the Contract
  • Change Approval by Both CMO And Company
  • Quality Agreement
  • Warehousing
  • Risk of Educating a Future Competitor
  • Dealing with Uncooperative Suppliers

Learning Objectives

This course is divided into three parts. Each section deals with specific information necessary to implement the successful selection, auditing, and management of a Contract Manufacturing Organization (CMO) for the production of one or more pharmaceutical products.

Section 1 – Selecting a CMO

  • Is outsourcing needed?
  • What makes a good CMO for your company?
  • Risks involved – e.g., product confidentiality
  • Regulatory considerations for your company and the CMO
  • Questions to ask in selecting a CMO

Section 2 – Auditing a Prospective CMO

  • Planning the audit
  • How to review their Quality Systems – does it fit your requirements?
  • Supplier considerations
  • Determining the CMOs technical competence
  • Key Points of the audit
  • Understanding the audit results

Section 3 – CMO Management

  • Preparing the Quality Agreement
  • Approving vendors
  • Continued Quality System review
  • Packaging/Labeling/Warehousing Considerations
  • Warehousing review