Introduction to ISO 13485 Quality Management Systems
Schedule:
- Available for private webinars
Duration: 2 hours with questions and answers
Synopsis: Many regulatory agencies demand companies maintain a viable quality management system as part of their market access requirements. This webinar outlines ISO 13485, the most commonly used quality management system standard, with a clause by clause discussion on and will include insight you can use on:
- Process based management systems
- Establishing quality system objectives
- Quality process and procedure development
- Creating the Quality Manual, work instructions and forms
- Integrating regulatory compliance issues
- Selecting quality system registrars, and
- Understanding the audit process.
Description: This webinar provides more than a broad understanding of individual clauses, we will discuss many options and enhancements that will make ISO an investment that will continue to pay you tangible benefits for many years to come. ISO 13485 is a versatile standard that can be used for regulatory compliance but more importantly can be used to organize and manage key value adding processes.
Who should attend: This webinar is ideal for new staff who must manage or work in the tightly regulated medical device manufacturing environment. It will also benefit regulatory compliance staff and those individuals who have to manage processes, conduct research and development, organize product testing or prepare regulatory applications as well as those who must interact with auditors and inspectors.
Presenter: Tim Duggins, Horizon Phoenix’s Senior Partner has more than 25 years experience in medical device quality systems and product testing. Tim is a skilled and fully accredited consultant and auditor with extensive experience implementing fully compliant regulatory and quality systems using EN/ISO 13485, USFDA QSR, Health Canada CMDR and/or all medical European Directives for more than 100 clients. An avidly sought after expert, he served as a consultant to such diverse organizations as federal governments, international non-governmental organizations, and industry from multi-national manufacturers to a three-person niche-market company. Tim has participated on numerous national and international committees writing product testing standards and helping create government regulatory processes; his product experience spans the entire medical device spectrum from high volume injection molded disposable products, digital radiography systems, in vitro diagnostic test kits to implantable cardiovascular devices.
Expert contributor: TBA
Registration:
$295
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