The Leader in Quality Life Science Training

Auditing and Qualifying Suppliers and Vendors

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    "Material was well presented and the course was fantastic! Breakout sessions helped reinforce concepts covered in training and the Course Director was excellent - very engaging!  Would like to see more Vendor Management related course offerings."


    Diana Z., Clinical Resource Specialist, Fujirebio Diagnostics

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    "Good pace – the Course Director kept the class involved. He effectively utilized real world examples to demonstrate problems encountered due to weak supplier evaluation systems." 


    Nicholas F., Corporate Manager, Supplier Quality Mgt., Boston Scientific

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    "Excellent course and very informational. I would highly recommend it to anyone needing to Audit vendors."


    Bertram B., Quality Engineer, Porex Technologies

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    "This course was very informative for someone just starting a career in auditing. I enjoyed the stories and different perspectives shared by all of the participants. I would recommend this class to anyone who is new to auditing."


    Dana S., Auditor – Corporate GxP Compliance, Emergent BioSolutions

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Course Director

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Course Fee

$2150.00 Regular Registration

$1950.00 Early Bird Pricing (Register 30 Days in Advance)

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Course Description

The auditing and qualifying training course includes a process for selection, audit, approval and qualification of vendors/suppliers based on the material/equipment/service being delivered. These decisions must be documented and must be based on the impact (risk) to the final product. Regulatory agencies hold companies accountable for delivering high quality products that meet all established requirements and specifications. Suppliers and vendors play a key role in accomplishing these mandates and it is the company's responsibility to ensure their suppliers/vendors meet all regulatory specifications for the supplied materials, components, equipment and/or services. Initially, the course will discuss the regulatory expectations and other industrial references/ standards that will impact your system and will include the general requirements of a vendor/supplier (outsourcing) control program followed by specific requirements for different types of supplied materials/equipment/services. During these sections, attendees will establish the documentation requirements, applicable audits and the impact of the quality agreement/contract details. For many years, the industry has implemented procedures for selection, approval and qualification of suppliers and vendors. However, in many cases these protocols were not being implemented effectively or formally documented. Making these programs part of a risk-based quality system approach that the FDA and other regulatory agencies have come to expect from industry is critical.



During this auditing and qualifying course, several interactive exercises will be included to provide opportunities for discussion and sharing of experiences.

Who Should Attend

This supplier quality management training course will be valuable for those in the pharmaceutical, biotechnology and medical device industries who are responsible for, or involved in, supplier/vendor management, qualification, procurement or maintenance. Manufacturing, Research & Development, Validation and QA/RA personnel will benefit as the course details all the steps necessary to carefully document and conduct the process of vendor selection while working within the confines of a risk-based audit system.



Third-parties looking to gain insight into how firms select and manage their outside vendors will also find this supplier quality management training course extremely useful.

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  • Learning Objectives

    Upon completion of this course, attendees will:

    • Understand requirements from regulatory agencies and other organizations in relation to supplier and vendor approvals and qualifications, including procedural and documentation needs. This will include an understanding which types of vendors are under regulatory agency control and which are not
    • Be able to develop adequate procedural and documentation controls for the selection, approval and qualification (certification) of vendors and suppliers. This includes the development of an audit program designed with different levels of formality depending on the criticality (risk-based) of the material/component/service being provided
    • Understand that controls are not limited to materials and components but also apply to contract service providers such as CROs, calibrations, laboratories, maintenance, contract manufacturing/packaging and others, including software vendors and data hosting providers
    • Be able to develop a quality agreement/contract with your suppliers/vendors that will define responsibilities and have adequate controls and documentation to maintain a business relationship based on trust and communication
    • Be able to proactively protect the quality of your products and effectively handle any deviations and non-conformities

    The course will use interactive workshops and discussions to enable delegates to exchange ideas and experiences while also learning from each other's experiences.

  • Agenda


    Regulatory Background and Industry References and Standards

    • FDA and EU perspectives on outsourcing management for medical devices, pharmaceuticals and Biotech products
    • Impact from ISO, ICH
    • Industry perspectives

    Fundamentals of an Outsourcing Management System

    • Procedure and Documentation
    • Pre-requisites – specifications and internal agreements
    • Selection of vendors/suppliers/service providers
    • Audits – a risk-based approach to determine the requirements and levels of the assessments
    • Approval of supplier/vendors – Quality Agreement/Contracts
    • Qualification (Certification) of Vendors and Suppliers
    • Maintenance of the program

    Audit System

    • Types of suppliers/vendors and impact levels to determine extent of audit
    • Preparing for the audit – checklist and plan
    • Execution and Documentation of the audit
    • Professional Ethics, Conduct, and Social Engineering
    • Remediation and conclusions of the audit
    • Maintenance of the control system – periodic audits of approved/certified/qualified vendors and suppliers

    Impact of the Quality Agreement/Contract

    • Vendor/supplier perspective
    • User perspective
    • Purpose and scope of the agreement
    • Requirements of the agreement/contract – formal communication and documentation
    • Change Control
    • Handling of Non-Conformances and deviations from contract

    Practical aspects of an Outsourcing Management Systems for Materials and Components

    • Establish specifications and expectations – internal agreement
    • Selection and approval process
    • Key areas to audit/assess before approval and adequate documentation
    • Acceptance of the COA
    • Qualification requirements and documentation
    • On-going monitoring (data collection and analysis)
    • Handling of non-conformances – change of vendor/supplier status when applicable

    Specifics related to Equipment/System Suppliers

    • Selection and audits
    • Approval
    • Quality Agreement and responsibilities
    • Documentation
    • User review and handling of non-conformances
    • Aspects related to computerized controlled systems –Hosting/Cloud, hardware and software development, specifications, testing, audits

    Specifics related to Contract Services – Manufacturing, Packaging, Calibrations, Laboratories, Equipment/System Maintenance

    • Selection and audits
    • Approval
    • Quality Agreement and responsibilities
    • Documentation
    • User review and handling of non-conformances

    Specifics related to GCP Contract Services

    • Selecting and Managing CROs, Phase I units, GCP Labs and others
    • EDC and Data Hosts
    • GCP and 21 CFR 11

    Management of Change within the Outsourcing Management System

    • Communication and documentation – agreement requirements
    • Internal review of changes from the supplier/vendor

    Recent FDA Observations and Perspectives


    Group Discussion Forum and Final Exercises

  • Testimonials

    "Material was very well laid out and helped deliver a clear understanding of the industry requirements and regulatory bodies. The instructor was very knowledgeable of Audits and suppliers, provide multiple real-life samples a made sure he answered all questions or inquiries the group made.  The instructor was very careful to point at the similarities of pharma and medical devices. It was good that he had a legal perspective on the presentation. The class is better when the instructor has the perspective of a legal auditor."

    Marvin F., Senior Principal Engineer, Stryker


    "Material was well presented and the course was fantastic! Breakout sessions helped reinforce concepts covered in training and the Course Director was excellent - very engaging!  Would like to see more Vendor Management related course offerings."

    Diana Z., Clinical Resource Specialist, Fujirebio Diagnostics


    " CfPIE is always the best! This course was very interactive and forces us to act on knowledge to form questions and agendas."

    Pam T., Consultant, QOS Bio


    " I really enjoyed this course and will look to see if there are others taught by this instructor. Well Done!!"

    Katie K., Lehigh Valley Technologies


    " This course was very informative for someone just starting a career in auditing. I enjoyed the stories and different perspectives shared by all of the participants. I would recommend this class to anyone who is new to auditing."

    Dana S., Auditor – Corporate GxP Compliance, Emergent BioSolutions


    " The trainer was excellent, nice with a lot of patience and enormous knowledge."

    Tamar M., GMP biological auditor, Teva


    " The Course offered a diverse set of materials regarding auditing and managing supplies."

    Terrin S., QA Specialist, U.S. Pharmacopeia


    "Good pace – the Course Director kept the class involved. He effectively utilized real world examples to demonstrate problems encountered due to weak supplier evaluation systems."

    Nicholas F., Corporate Manager, Supplier Quality Mgt., Boston Scientific


    "Course is excellent! I learned a lot, especially during interactive sessions."

    Sudha K., QA Specialist, Emory Healthcare


    "The interactive exercises were fun, informative, and were one of the driving factors of the course."

    Maurice F., QA Manager, HTL-Strefa, Inc.


    "Interaction with other attendees from within industry was most valuable; it was great to benchmark with others on current and best practices and share experiences. The instructor was very supportive of this and actively encouraged questions and participation."

    Sharon T., Principal QA Specialist, Astra Zeneca


    "The course information and handouts will be extremely useful in assisting me in developing our quality auditing program."

    J. David G., Service and Quality Engineer, Cyclotron


    "Excellent course and very informational. I would highly recommend it to anyone needing to Audit vendors."

    Bertram B., Quality Engineer, Porex Technologies


    "Excellent knowledge and even better documentation!

    Ken H., Lead Auditor, IBA

Registrant Information:

Each person attending a course will be asked to set up an Attendee Profile Account during the registration process. Creating an Account helps you view your order history and manage your training programs. If you are registering for others, please set up an Account in the Attendee’s name. If you are registering more than one person, you’ll need to set up a separate account for each Attendee.

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