Webinar On FDA proposed changes to ISO 13485: 2015 and Medical Devices Quality Management Systems

Event Details

Time: December 9, 2014 from 1pm to 2:30pm
Location: Canada
Street: 5939 Candlebrook Court
City/Town: Mississauga
Website or Map: https://compliancetrainings.c…
Phone: 4169154458
Event Type: webinar
Organized By: Compliance Trainings
Latest Activity: Dec 9, 2014

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Event Description

Description :

ISO 13485:2015 - What’s coming? Understand proposed changes being worked on by the ISO technical committee for updating the ISO 13485:2003. Awareness of the current requirements and proposed changes will facilitate your preparing in advance and navigating your way through the harmonized international arena to expand your product marketing strategies.

You will gain a thorough insight into the specific auditing requirements of the International ISO 13485 Standard requirements for medical devices. This class will truly build your knowledge from the fundamental principles and help you grow into fulfilling the regulatory requirements as a product developer, manufacturer, auditee for external FDA type of audits and serve as an internal or supplier auditor.

The webinar will also focus on the major difference in expectations between FDA Quality System Regulations and Quality System inspection Techniques (QSR and QSIT) and ISO 13485 for globally distributed products. Proposed changes to ISO 13485 for additional vigilance in areas such as supplier management, risk management and training will be discussed.

Areas Covered in the Session :

You will gain a thorough understanding of:

Requirements of ISO 13485

How to carefully attend to every aspect of the related biomedical standards

Document control

Purchasing Controls

Production controls

CAPA

Identification and Traceability

Upcoming changes ISO 13485:2015

How ISO 13485 differ from FDA QSR 21 CFR 820 requirements

Regulatory expectations of other major growing geographies in the world