The Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485: Navigating Regulatory Requirements
Upcoming Virtual Courses
Quality Systems
Quality System Regulation 21 CFR 820 & ANSI/AAMI/ISO 13485 (Nov24)
Nov 18 to Nov 22, 2024
Quality Systems
Quality System Regulation 21 CFR 820 & ANSI/AAMI/ISO 13485 (April25)
Apr 14 to Apr 18, 2025
Quality Systems
Quality System Regulation 21 CFR 820 & ANSI/AAMI/ISO 13485 (Aug25)
Aug 18 to Aug 22, 2025
Overview
Objectives
Who Should Attend?
Materials
Virtual Training Information
Faculty
Margaret Koga Ward
Margaret Koga Ward has over 30 years of medical device experience, specializing in Product Development, Quality Management Systems, Internal and External Auditing, and Risk Management. She is currently an Independent Consultant, a Notified Body Auditor specializing in MDSAP and ISO 13485 audits, and an AAMI University faculty member. Her passion is helping companies achieve their quality management system and product development goals to advance their devices from concept through to commercialization within an FDA and ISO compliant quality system.
Ms. Koga Ward has served as a consultant for the FDA to develop and present quality management training courses for multiple divisions within the FDA.
Prior to becoming an independent consultant, she held various senior level project management, quality management system, and engineering positions leading cross functional teams throughout all phases of product development and quality system integration.
Ms. Koga Ward served as the Project Manager responsible for the integration, development, and commercialization of a novel, invasive device. She was also the senior consulting engineer for an Arizona based consulting firm; in this role she managed quality and product development projects for a wide range of Class I, II, and III medical devices including orthopedic, cosmetic, cardiac, ocular, and gastro-esophageal devices. She is an established subject matter expert for FDA regulations, ISO 13485, risk management, packaging, human factors, biocompatibility, and sterilization.
Ms. Koga Ward holds a Mechanical Engineering degree from California Polytechnic University San Luis Obispo.
Philippe Joly
client firms to establish cGMP/QSR-compliant quality systems or to improve the efficiency of the existing ones. He has 10 years of experience in developing and delivering training on cGMP/QSR. Prior to this job, Philippe Joly has been involved in sales, marketing and product development for two international companies involved in the biopharmaceutical and medical device market.
Philippe Joly has a MS degree in Biochemistry and Microbiology and a Master's in Management and Marketing. He has led several workshops and task forces (Personnel qualification, cleaning validation, validation of computerized systems, risk management) for the two main French Pharmaceutical societies.