The FDA requires that manufacturers of medical devices have a documented process to assess its suppliers and contract manufacturers, that they have implemented that process, and that the process is effective. Having an effective Supplier Relationship Management program will result in streamlining the supply chain, ensuring a more consistent level of quality components, materials and components, and be more cost effective to the manufacturer.
Why Should You Attend
Failure to adequately assess and control your supplier/subcontractor pool can result in dire consequences for an organization. Aside from the regulatory implications for failure to comply with FDA’s requirements, not assessing and monitoring your suppliers can result in product recalls,high levels of complaints,potential patient/user injuries and deaths, and expensive lawsuits. Not explicitly defining the responsibilities of your suppliers can lead to adulterated and misbranded product, as well as unnecessary costs associated with cost of good and overhead. Assessing and approving your suppliers before placing the first order with them will eliminate many headaches for a medical device manufacturer.
This webinar will provide attendees with the information and tools necessary to develop, implement, and effectively utilize and maintain a program for Supplier Quality Management that will satisfy the FDA’s requirements without creating undue burdens for the organization.
Areas Covered in this Webinar
This session will discuss:
This webinar will assist the participant in:
Who Will Benefit
This webinar will provide valuable assistance to the following departments of the FDA-regulated industries:
Les Schnoll has extensive experience in quality assurance, quality control, auditing, regulatory compliance, management, and microbiology in the medical device, pharmaceutical, and clinical/pre-clinical industries. Schnoll is recognized for achievements in developing value-added quality management and regulatory compliance systems. He is recognized by the Medicines and Healthcare Products Regulatory Agency (MHRA) (formerly the Medical Devices Authority) in the United Kingdom to perform assessments to the European Union Medical Device Directive and the European sterilization standards.
Les is the Principal of Quality Docs, LLC, providing quality and regulatory services to the FDA-regulated and Arizona Department of Health-regulated industries. He is also currently an Instructor in the Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Device program in the College of Professional Studies at Northeastern University and a Faculty Associate at Arizona State University, College of Nursing and Health Innovation, in the MS Regulatory Science and Health Safety Program.
He was most recently the Vice President, Quality Assurance and Regulatory Affairs with the J.T. Posey Company and has held executive positions at ThermoGenesis, Theravance, Solectron, Hill-Rom, Gliatech, Cyberonics, Southern Research Institute, KPMG Quality Registrar, and Dow Corning Corporation. Les has conducted various training programs, audits, and systems development in the United States, Canada, Europe, South America, Russia, Australia, and the Pacific Rim.
Schnoll has written articles for such publications as Medical Design and Material, ISO 9000 Handbook of Quality Standards and Compliance, Pharmaceutical and Medical Packaging News, Food Quality, and Quality Progress. He is also the author of The CE Mark: Understanding the Medical Device Directives and The Regulatory Compliance Almanac, published by Paton Press.
Schnoll's professional affiliations include the American Society for Quality as a Certified Quality Engineer, Certified Quality Auditor, and Certified Quality Manager; the Regulatory Affairs Professionals Society as Regulatory Affairs Certified; the Institute of Certified Quality Consultants as a Certified Quality Consultant; the American Society for Microbiology as a Registered Microbiologist (clinical microbiology) and Specialist Microbiologist (consumer and industrial microbiology); and the International Register of Certified Auditors as a certified lead assessor.
He is a Fellow of the Chartered Quality Institute (formerly the Institute of Quality Assurance) and is accredited as a Chartered Quality Professional. Schnoll is also a former member of the United States Technical Advisory Group to Technical Committee 176, International Organization for Standardization and the United States Technical Advisory Group to Technical Committee 210, International Organization for Standardization. Les has a Bachelor of Science degree in biology from Ursinus College, a Master of Science degree in microbiology from Villanova University, a Master of Business Administration in human resources from Central Michigan University, and a Juris Doctor in health law from Concord University School of Law.View all trainings by this speaker