Over the past year, the FDA and ISO authorities have placed an unprecedented emphasis on purchasing controls and linked processes.  The final GHTF document (SG3/N17R9:2008) addressing the Control of Products and Services Obtained from Suppliers is in effect and promises to have far-reaching consequences during FDA inspections, supplier audits and ISO audits.   This two-day workshop is designed for individuals who perform, supervise, manage, audit or oversee the process for purchasing materials and services.

The course will be of equal value to those responsible for the acceptance activities related to the release and receipt of these materials and services in a regulated environment.  This includes, but is not limited to, professionals working in purchasing, design controls, quality control, quality assurance, process ownership, auditing and, alternatively, suppliers being evaluated and monitored by medical device companies.  The workshop will also benefit those process owners who are involved with meeting the customer’s requirements, i.e. the medical device companies and the FDA.

Learning Objectives

Upon completion of this course, attendees will have a working understanding of regulatory agency and ISO expectations and will have gained the background knowledge necessary to effectively establish and implement a process for purchasing controls/acceptance activities.

Participants will gain practical experience from real-life examples, and an interactive foundation for benchmarking and cross-functional discussions.  Because an important segment of the session will focus on the logistics and documentation expectations of the evaluation and monitoring of suppliers, this course will introduce participants to the affects of risk management on decision-making and compliance.

Course Description

This workshop provides comprehensive and up-to-date knowledge of purchasing controls/acceptance activities and subsequent process control. The course covers regulatory expectations regarding the type and extent of control to be established and documented within an organization’s quality management system.  Additionally, the ramifications of outsourcing in the United States and the use of foreign platforms will be discussed.  When a medical device manufacturer chooses to utilize suppliers, the manufacturer should ensure control over any product or service obtained from such suppliers as defined within the quality management system.  These controls may extend further if a supplier subcontracts work. 

This course will address purchasing controls/acceptance activities in terms of the following:

• Planning during design controls and (then) during production/process controls
• Selection of potential suppliers
• Supplier evaluation and acceptance
• Purchasing controls, data expectations and compliance
• Ancillary processes supporting delivery
• The measurement/monitoring/supplier dashboard
• The Strategy of Risk Management Practices
• Feedback and Communication

View Course Agenda