Supplier Auditing for Medical Device Companies
May 18, 2020 - CA USCompliance4all
support@compliance4All.com
Phone:8004479407
Overview: This webinar can help you understand your responsibilities in terms of Purchasing Controls enabling you to provide safe and effective products to your customers. Learn how to prevent quality and compliance problems by having a strong system for supplier audit and management! This webinar will help you to understand the regulations and how you can translate them into an efficient and effective process for managing your suppliers. You'll learn about the essential elements of supplier audits. We'll discuss the process steps for supplier control and how it relates to other parts of your QMS including receiving and acceptance activities. A well-designed supplier audit program can be an effective tool in understanding, communicating, and reducing quality and compliance risk. Why you should Attend: Inadequate supplier/purchasing control can lead to a multitude of problems including rejections or delays at receiving inspection; non-conformances and scrap on your manufacturing lines; and quality problems that can manifest later in the field resulting in MDRs and recalls. Supplier management requires clear information about your supplier's strengths and weaknesses and capability to consistently meet your requirements. And without an effective suppler audit program, supplier management lacks awareness of the issues within their suppliers. Management is blind to the problems with their suppliers and the risks that poses. However, many companies conduct audits only because they are required to by regulation. Businesses often see supplier audit as a non-value added activity leading to meaningless findings, bureaucracy, and cumbersome processes. And despite having supplier audit program, management is often surprised by quality problems. This webinar can help you to avoid these problems. Areas Covered in the Session: Understanding the regulations and expectations Lessons Learned Purchasing Controls Process Evaluation of Suppliers Balance between purchasing control and receiving inspection Which suppliers need to be audited Auditing Criteria Auditing Process Performance Management Feedback and Communication Best Practices Inspection Readiness Learning Objectives: Responsibilities for supplier management and purchasing controls Balance between supplier management and receiving inspection Enforcement case studies and lessons learned Quality agreements Using a structured program to identify areas of risk leading to an effective audit strategy How to develop a meaningful structure of oversight, audit, transparent communication, and escalation to management review Audit planning, execution, and follow-up How to ensure management gets valuable information from your audit program Who Will Benefit: Supplier Engineers Supplier Auditors Supplier/Purchasing Managers Quality Engineers Supplier Quality Engineers Compliance Personnel Compliance Specialists Quality/Compliance managers or directors for Medical Device companies General Managers wanting to learn how to Management Review and expectations Speaker Profile Susanne Manz ,MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. While at GE, J&J, and Medtronic, Susanne worked in various world-wide roles including Executive Business Consultant, WW Director of Quality Engineering and, Design Quality, and Director of Corporate Compliance. Susanne has a BS in Biomedical Engineering and an MBA from the University of NM. She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson. Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and Certified Quality Auditor (CQA) certification from the American Society for Quality. Susanne has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance. Event link: https://www.compliance4all.com/webinar/---502946LIVE?channel=lifescienceleader-May_2020_SEO Contact Info Netzealous LLC, DBA -Compliance4all Email: support@compliance4All.com Phone: +1-800-447-9407 Website: https://www.compliance4all.com/