Kenneth Christie has over 25 years of experience in the areas of Manufacturing of Sterile Products, Quality Assurance, and Validation Management. Prior to becoming the Vice President of Consulting Services for VTS, Mr. Christie spent thirteen years with the Parke-Davis Sterile Products Division of Warner-Lambert where he served as Manager of the Validation Department for eight years. His main responsibilities were management of all validation activities associated with the plant's equipment, utilities, computer control systems, and third party biotechnology companies. Mr. Christie also managed contracted validation personnel and defended all corporate validation practices to regulatory agencies such as the FDA, CBER, CDER, and the United Kingdom's MHRA Division.
Mr. Christie also spent seven years working for Wyeth Laboratories Sterile Biological Vaccines Division of American Home Products as a Manufacturing Supervisor. Mr. Christie is an active speaker and/or trainer for several professional organizations. On the international arena, he has provided pre-FDA audit inspections for foreign firms, along with authoring articles on the challenges of aseptic processing. In his current position, Mr. Christie is a trainer of numerous GxP related topics, provides regulatory consulting and commissioning services and helps develop the corporate business plans.
Mr. Christie possesses a B.S. degree in Biology with a Chemistry minor and holds an Executive Masters Degree in Business Administration from Michigan State University.
Presentation Materials, Luncheon, Refreshment and Free Parking
Note: Please indicate any special Dietary requirements when registering for the course
April 13, 2012
9:00 a.m - 5:00 p.m.
CAD $695.00 + HST
AAPS Training Center
200 Consumers Road, Suite 200, Toronto, Ontario, M2J 4R4
Tel: 416-502-2277
Objective – Supplier Quality Agreement:
As companies today increasingly depend on suppliers and vendors for services, raw materials and various components, the need to establish quality agreements grows with it to help assure all responsibilities and expectations of both parties are clearly defined. Quality agreements include defining the responsibilities of each party and cover such critical topics as general responsibilities, process controls, material handling of incoming product/components, processing issues, handling of changes and non-conformities, shipment issues, etc. The establishment of quality agreements is usually the second step in the qualification of suppliers and vendors and follows a successful audit of the supplier. Quality agreements can also help to address any issues that may have been discovered during the audit in order to avoid future potential and similar issues. This workshop will focus on expectations of quality agreements in various guidance documents and will cover in more detail the various sections of a quality agreement as listed previously.
Objective – Vendor Audit:
In 2010, there were several major pharmaceutical and biotechnology companies that were issued consent decrees for not maintaining quality systems that impacted the products, safety, efficacy and purity. In some of these cases, major contamination issues were believed to be caused by the raw materials used in the final product. These claims made the need for vendor audits even more demanding and one that regulators began to focus on during their inspections. Vendor audits are a basic requirement of quality systems associated with medical devices and in pharmaceutical cGMP regulations. This workshop will focus on how to develop and maintain a compliant vendor audit program and to provide a framework for establishing such procedures.
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