Supplier Audits: A Critical Quality System Requirement Workshop

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Dates Available

March 8, 2019

Time

9:00 a.m. – 5:00 p.m.

Cost

CAD $585.00 + HST

Location

AAPS Training Center
200 Consumers Road, Suite 200, Toronto, Ontario, M2J 4R4
Tel: 416-502-2277

Distinguished Faculty

Ms. Deborah Gordon B. Sc

Instructor and Program Chair
AAPS

Deborah Gordon, B. Sc., Dip. Pharm. QA, began her career in the Sciences as a Forensic Analyst working on crime scenes and in the lab, analyzing evidence to be presented in court. Her attention to detail, which was critical to crime scene investigation, eventually led her to the Quality Assurance field. Her experience as a Forensic Analyst paved the way for her career growth. In 2008, Deborah completed her training as an Auditor by successfully passing the American Society for Quality Auditor examination, (ASQ, CQA).

Deborah has 16 years of experience in the pharmaceutical industry, including 15 years of auditing experience. Her experience includes Quality Systems for storage, distribution, wholesaling, packaging/labeling and manufacturing of pharmaceuticals. She has done extensive work in temperature mapping of warehouses, fridges and freezers. As a leader in pharmaceutical quality assurance, she also enjoys the challenge of auditing and teaching.

Abstract

Today, nearly all companies are dependent on a variety of suppliers for various components, services and materials. The pharmaceutical industry requires quality audits as defined in the quality systems requirements (QSR) and the FDA will expect companies to validate the acceptability of using Certificates of Analysis (C of A) supplied by these suppliers. The sheer number of vendors today that companies depend on have presented a challenge in performing them and organizing an effective method of how to qualify them, what to look for when auditing, and how to follow-up on issues found. Other issues with suppliers is what to do with those that are deemed unacceptable, yet may be the only supplier of the material, component or service purchased. The success of a vendor audit program is to convince the vendor that there is a benefit to both parties and not just one. The purpose of the vendor audit is to assure processes are in place to assure the control of outsourced activities and quality. Once it is determined that a vendor is considered “acceptable” for the component or services sought, an approved, written agreement, (commonly referred to as a Quality Agreement) should be written. This agreement defines quality requirements, responsibilities, and communications necessary for quality-related activities between the two parties. Records of acceptable vendors should be established and maintained via an Approved Vendor List.

This training will look at the regulatory requirements for performing supplier audits and what to look for when performing the initial audit to determine capabilities and quality practices employed. Topics will include how to classify suppliers based on what is purchased, the various types of audits that can be performed (on-site, questionnaire, etc.) a checklist of areas to evaluate during an audit and the follow-up to issues that are found deficient. In addition, re-audits and their frequency will be discussed. Other issues to be discussed will include what to do prior to the audit, what to avoid during the audit, summary of observations found and subsequent follow-up to the responses expected. Attendees will be able to ask questions related to their own supplier plan or to addresses issues they may have with current suppliers. An audit checklist will be reviewed and discussed.

Topics to be Covered:

  • Current regulatory requirements for supplier audits
  • How to write an audit procedure to cover the following items:
    • an objective,
    • audit scope,
    • an audit schedule,
    • assignment of responsibilities,
    • evaluation criteria,
    • management review of results, and
    • corrective action policies, schedules, etc.
  • How to classify suppliers based on a risk assessment and nature of materials, services or components purchased.
  • Review of the areas to cover (audit checklist) during a supplier audit.
  • Review of activities to be performed after completion of audit such as actions taken to observations or lack of responses.
  • Discuss actions to be taken when suppliers are deemed unacceptable and potential impact on other quality systems.
  • Review of an actual case studies to highlight topics listed above

Question and answer period

Who Should Attend

  • Manufacturing
  • Validation
  • Quality Unit
  • Regulatory
  • Engineering
  • Vendors
  • Management

Registration Fee Includes

Presentation Materials, Luncheon, Refreshment and Free Parking (Please indicate any special Dietary requirements when registering for the course)

Note: Registration closes one week prior to the start of workshop.

Certificate of Attendance and Course Material

  • All participants will receive a certificate of attendance upon completion of the course.
  • The participants will be receiving specially prepared course manual.