ISO 13485 Quality Management System

Duration: 60 Minutes
Organizations wishing to market Medical Devices in Europe must develop Quality Management Systems in accordance with ISO 13485. Such Quality Systems will also be beneficial for organizations seeking to gain marketing permission from the FDA.
ISO Quality Management System
Instructor: Peter Spath
Product ID: 500210
ISO 13485 is becoming the de facto international regulatory requirement for Medical Device manufacturing. Introduced in Europe as one of the requirements to obtain CE Marking for products, it has also gained acceptance within the FDA.

Why Should you Attend:
Medical Device manufacturers must document and implement processes for Corrective and Preventive Actions (CAPA) to comply with Quality System and Regulatory requirements. These processes include those to adequately measure, analyze, and improve nonconformities identified through any number of sources. Organizations must also develop preventive action processes to address potential nonconformities of systems, processes or products.

Objectives of the Presentation:
  • Overview of ISO 13485 Quality Management System
  • Discussion of key requirements
  • What written procedures and training are required
  • How should internal audits be conducted
  • Understanding of what auditors expect
Who can Benefit:
  • Quality Assurance Managers/Personnel
  • Regulatory Managers/Personnel
  • Manufacturing managers, supervisors & personnel
  • Internal Auditors
  • Senior management executives (CEO, COO, CFO, etc.)
  • Project Managers
$375
Recorded Session for one participant
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Instructor Profile:
Peter Spath is currently a freelance consultant serving the Medical Device community by providing a variety of quality and regulatory consultation on contractual basis remotely and on-site. Services include: leading Quality System audits in accordance with ISO 9001, 17025, and 13485, Canada's CMDCAS regulations and FDA GMPs for both Medical Devices and Combination Devices. He has over 20 years of experience working with international regulations and standards as a Certified Lead Auditor. Recognized as an expert in ISO Standards and Federal Regulations, especially those governing Electronic Records and Electronic Signatures, he led regulatory compliance assessments throughout Fortune 500 Companies as well as their suppliers across the United States, Mexico, and Europe. Mr. Spath developed and facilitated the implementation of quality management systems in numerous internal organizations and key contract manufacturers in Germany. He has also successfully managed FDA GMP and EPA GLP investigations in a variety of organizations.

In addition to his expertise in Quality Systems and Regulatory requirements for Medical Devices, Mr. Spath has served on EPA committees to develop new regulations for environmental laboratory accreditation. He was also appointed to the Environmental Laboratory Accreditation Board, an EPA Federal Advisory Committee (FACA), providing advice to the EPA Agency Administrator.
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