- OVERVIEW AND WHY SHOULD YOU ATTEND
- AREAS COVERED AND LEARNING OBJECTIVES
- WHO WILL BENEFIT
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.Click to View the Pricing Plan
This session will discuss:
- Supplier Quality Management Overview
- Supplier Selection, Approval, and Disapproval
- Supplier Evaluation and Performance Monitoring
- Supplier Approval Status: Approved, Conditional, Disapproved, Probationary
- Supplier Change Control
- Supplier-Related Corrective and Preventive Action, Continuous Improvement, and Development
- Supplier Quality Agreements
- Supplier Contract and Agreement Administration / Supplier Records
This webinar will assist the participant in:
- Understanding the FDA’s requirements for medical device supplier assessment and approvals.
- Learning “who” are considered to be suppliers
- Knowing to structure a Supplier Quality Agreement
- Selecting the potential methods for evaluating and assessing suppliers
WHO WILL BENEFIT
This webinar will provide valuable assistance to the following departments of the FDA-regulated industries:
- Quality Assurance/Quality Control Directors, Managers, and Specialists
- Regulatory Affairs/Regulatory Compliance Directors, Managers, and Specialists
- Purchasing/Materials Management Directors, Managers, and Specialists
- Engineering/Development Directors, Managers, and Specialists
- Document Control Managers and Specialists
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
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Thank you for the spreadsheet webinar. The webinar was informative and helpful. Although many of the concepts are known and understood by Industrial and Process Engineers, it is always helpful to have a straightforward review. The spreadsheet will be beneficial in being able to help identify areas of risk and areas that may require some attention.
Benchmark Electronics , ******** Engineer
This was a very informative session, it did help my company by raising awareness in areas we lack policies. The only thing I would suggest get added to the session is direct information relating to Accounting, ex. Taxation rules for record retention as they are some records which a company is required to keep indefinitely.
First MCO, ***** Manager
Overall I found the video conference well organized and very informative. The presenter, Ronald Adler, was certainly extremely knowledgeable and presented the subject matter in a well organized, direct and succinct manner. Afford the attendee the ability to track and record paid attendance/activity without a lot of tracking and follow up in order to gather the necessary information required to record the CPEs earned and paid for.
Dynamic Marketing Systems, VP Finance & Human Resources
As this was our first experience, we did not know what to expect. I believe the webinar was informative and to the point, and explained to us the purpose of the I-9, and how the company can be affected by an audit. It really motivated us to review our files and bring them up to date.
Young Transportation, ****Coach****
I have participated in several webinars hosted by Compliance Global on various H&S topics. They are always precise, technologically-oriented, and easy to use and partake in to further my knowledge of current Health and Safety regulations and topics.