Best practices in supplier evaluation and assessment and internal auditing to meet US FDA and ISO 13485 requirements
Module 1:
Supplier Evaluation and Assessment Program: How to meet FDA QSR and ISO 13485 requirements in a cost effective manner
Many companies spend a great deal of time and money in pursuit of compliance with QSR regulations and ISO standards. Many companies can spend MUCH LESS time and money, and still be in control of their suppliers and in complliance with the regulations. This presentation will review the QSR and ISO requirements for supplier evaluation and assessment, and provide cost efficient, equally compliant options to many of the most common practices.
What Attendees will Learn:
QSR and ISO 13485 requirements for supplier selection and assessment, How to qualify new suppliers in a cost efficient manner, How to assess current suppliers in a cost efficient manner, How to perform supplier-related corrective action, Minimum documentation requirements for supplier qualification, assessment, and related corrective action.
Instructor Profile: Jeff Kasoff, RAC, is the Director of Regulatory Affairs at Life-Tech, Inc., a leading manufacturer of consumables and instrumentation in the urodynamic and pain management fields. Jeff is responsible for oversight of corporate compliance with domestic and international regulations, preparation of submissions, and is primary liaison with regulatory agencies and notified bodies.
Module 2: Internal Auditing Essentials for Medical Device Manufacturers to comply with FDA QSR and ISO13485
This webinar will provide the principles and practices needed to effectively develop, implement, and perform internal quality management system audits that comply with the requirements of the FDA QS Regulation and ISO 13485. Participants will gain an understanding of QSR/ISO requirements and the skills necessary for effective internal auditing.
What Attendees will Learn:
Essentials of an internal quality audit program, How to implement an effective and efficient program, Audit phases, How to create an audit plan, Conducting the audit, including questioning techniques and communications, How to avoid common mistakes during audits, Corrective action for internal audits, How to select and train auditors.
Instructor Profile:Susan C. Reilly Principal for Reilly & Associates, has over 20 years of quality assurance, quality engineering, and regulatory compliance experience in the medical device field. She is a recognized expert in the medical device industry, and is an ASQ Certified Quality Engineer, Quality Auditor, and Quality Auditor-Biomedical and an RAB QMS Provisional Auditor. Prior to becoming an independent consultant in 1999, she was Director, Quality Assurance and Compliance, at Medical Device Consultants, Inc. (MDCI) and Manager, Quality Assurance at Deknatel Division, Pfizer Hospital Products Group, Inc.
