Supplier Qualification and the Challenges
March 1, 2017
9:00 a.m. – 5:00 p.m.
CAD $585.00 + HST
AAPS Training Center
200 Consumers Road, Suite 200, Toronto, Ontario, M2J 4R4
Chief Operating Officer
Mr. Kenneth Christie has over 30 years of sterile manufacturing and regulatory GMP consulting experience in the areas of Quality Assurance and Validation Management in the pharmaceutical and biotechnology industries. Mr. Christie is currently the Chief Operating Officer for VTS Consultants, Inc located in Amhesrt, MA. Specifically, his responsibilities include quality system auditing, GMP training, and serving as a subject matter expert for aseptic manufacturing processes, medical devices, APIs and solid dosage processing equipment, utilities, and systems on a global basis. Mr. Christie also performs vendor audits, site pre-approval inspections and assists clients with addressing and correcting regulatory observations.
Mr. Christie was the Validation Manager at Parke-Davis’ Sterile Products Facility where he was involved in the review and approval of all facilities, equipment, and system commissioning/qualification activities. He had routine interaction with the FDA and European inspectors (EMEA), corporate management and third party contract-manufacturing representatives to defend validation practices and to assure regulatory compliance for the manufacture of aseptically produced products.
Mr. Christie is a speaker and trainer for several professional organizations in the US, Canada, Europe, and Asia and is a published author of several articles dealing with the challenges of aseptic processing. Additionally, Mr. Christie serves as a member of the ISPE’s Professional Certification (PCC) Commission as an Examination Development Committee (EDC) member.
He possesses a BS degree in Biology from Shippensburg State University (PA) and an Executive MBA degree from Michigan State.
Today, nearly all companies are dependent on a variety of suppliers for various components, services and materials. These can range from laboratory testing that is used for product and component release to cleaning activities. The life sciences industries are required to qualify their suppliers to assure they meet the quality expectations of the applicable regulations that apply to them and those as defined in the quality systems requirements (QSR) for medical devices. The qualification activities can range from a paper evaluation to an on-site audit with questionnaires depending on the level of risk the component or service may impact on the final quality of the product. The FDA, along with Health Canada and the EU will expect companies to demonstrate the acceptability of using Certificates of Analysis (C of A) provided by these suppliers. One of the methods used to justify the acceptance and use of these C of A’s is to demonstrate the respective supplier has a well-established quality system that provides consistent quality and meets the quality expectations of their customer. The use of audits, questionnaires, or both will be discussed and reviewed during the workshop.
The sheer number of suppliers today that companies depend on have presented a challenge in performing audits where required and organizing an effective method of how to qualify suppliers, what to look for when auditing, and how to follow-up on issues found. Other issues associated 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 components. Once it is determined that a vendor is considered “acceptable”, 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 Supplier List.
This workshop will focus on the major components of a supplier qualification program, the topics to be included in a supplier qualification procedure and the review of a typical audit checklist and summary report. Actual case studies will be discussed highlighting various topics covered during the workshop for further discussion. In addition, the workshop will cover the importance of quality agreements and the FDA’s current Guidance to Industry on this topic.
Why Should You Attend?
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. Quality agreements as another expected part of a supplier qualification program will be reviewed and the current FDA Guidance to Industry on Quality Agreements will be reviewed as to the expectations and items that should be included in them. Actual case studies will be discussed to generate discussion and to highlight some of the challenges that supplier qualification programs present to every company.
Areas to be Covered:
- Current regulatory requirements (FDA, Health Canada and the EU) for supplier audits.
- 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 the FDA;s Guidance to Industry on quality agreements, another important aspect of a supplier qualification program.
- Review of items to include in a supplier qualification procedure.
- Review of an actual case studies to highlight topics listed above.
- Question and answer period.
Groups That Will Benefit From Attendance:
- Quality Unit
- Service, equipment and component suppliers
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.
Registration Fee Includes
Presentation Materials, Luncheon, Refreshment and Free Parking
Note: Please indicate any special Dietary requirements when registering for the course