Quality Management for FDA QSR and ISO13485 Compliance: Pack of Two Courses

Instructors: Susan C Reilly, William G Mclain
Product ID: 700289

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Best practices in Quality Management System and management controls needed to meet US FDA and ISO 13485 requirements


This pack of two training courses provides 2 hours of training on basic requirements and best practices of quality management system for non-Regulatory and Quality Assurance experts in the medical devices industry as well as principles and practices needed to effectively develop and implement the Management Controls necessary to ensure an effective Quality Management System (QMS) and to comply with the requirements of the FDA QS Regulation

Module 1: Management Controls needed for an effective QMS to meet FDA QSR and ISO 13485 regulations

Participants will become familiar with the governing requirements for management controls by understanding the responsibilities that executive management is obligated to meet and the challenges executive management faces in meeting QMS and FDA QS requirements.

What Attendees will Learn:

Importance of Management Controls, Legal obligations, Commitment, Management Controls (quality planning, quality policy, quality objectives, management representative, management review, human resources, training), Challenges for your company, Meeting those challenges.

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.

Module 2: 21 CFR Part 820 and ISO 13485:2003 - Best Practices in Quality Management System Basics

For those starting in the medical device industry, understanding how a quality management system works, how it's intended to fit together can be a mystery. This seminar will focus on helping the non-RA/QA expert understand the basic requirements and best practices of a QMS. We'll discuss how the elements work together and how the QMS can be used to work for your business, not against it.

What Attendees will Learn:

Quality Management System Basics, Knowing which QMS elements are important to my operation, Working effectively with vendors, Piecing together complaints, manufacturing issues, vendor issues with CAPA, How does risk management fit into the QMS?, Deciding between ISO 13485:2003 and 21 CFR Part 820.

Instructor Profile: William G. Mclain RAC, B.S.E. is the President and Principal Consultant for Keystone Regulatory Services, LLC. He has over 15 years experience in product development, domestic and international regulatory affairs and risk management, and quality management system design in the medical device industry. He has contributed to the timely development and market introduction of cardiovascular, anesthesiology, gastroenteral, diagnostic and general surgical devices by providing regulatory, quality system and risk management strategy, oversight, and support.

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