Risk Management, more than ISO 14971
Schedule:
- Available for private webinars
Duration: 2 hours with questions and answers
Synopsis: The risk management process – identification, elimination of risk (where possible) and mitigation of residual risks – is tightly embraced by every major regulatory jurisdiction. ISO 14971 is the most recognized Standard for this process but effective risk management involves more activities going beyond the design stage into production, post market surveillance, corrective/preventive actions, customer complaints and vigilance activities. Those who perform risk management only during the design phase fall short of their regulatory obligation and fail to take advantage of most risk management benefits. This webinar will review risk management requirements beyond simply compliance and will include insight you can use on:
- Risk management during design and post design
- Risk management tools (FMEA, HAACP, CAPA)
- Identifying hazards and risks
- Evaluating hazards and risks (quantitative and qualitative)
- Risk management and Post Market Surveillance, CAPA and Vigilance activities
- Justifying ALARP decisions (including taking no action)
- Comprehensive report writing, and
- Presenting risk assessments as part of regulatory inspections or regulatory applications.
Description: Risk management is the central process in proving your device is safe and will perform as intended. It is a fundamental part of your regulatory applications and provides key protections in the event of a mishap or accident. An effectively managed risk process provides many benefits beyond simple regulatory compliance. This webinar will provide many insights on using risk management activities for your greatest benefit as well as regulatory compliance. Following this webinar, you will never look at risk management in terms of design only again.
Who should attend: This webinar is ideal for regulatory compliance and R&D 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
For more information or to pose a question about this webinar
contact: info@raqawebinars.com
(Please make sure you note the Webinar and date you are inquiring
about in your email)
