Industries: Pharma / BiotechMedical Device

Auditing and Qualifying Suppliers and Vendors

Course Director: Sean Develin

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

Auditing and Qualifying Training Course

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

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 the course, several interactive exercises will be included to provide opportunities for discussion and sharing of experiences.

Who Should Attend

The 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 course extremely useful.

Course Agenda

First Day

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

Second Day

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

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.

Testimonials

" 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