2016 - Webinar on ISO 13485 2016 utilizing Principles of Lean Documents and Lean Configuration

Description :
Medical device designers and manufacturers are required to follow ISO 13485, and will be expected to implement the 2016 revision changes. There is an additional responsibility to ensure that each and every step of the manufacturing process is controlled by work instructions, SOPs, set-up instructions, equipment maintenance, and support functions, and that evidence of this work is maintained by controlled records.
It would be a major oversight to think of these changes as anything but a profound game-changer in terms of expectations and requirements.
Rather than wait to be surprised by unexpected requirements, or to implement them haphazardly, it is better to understand what is coming and begin to plan for the changes that will permeate throughout all areas of your organization’s quality processes.
This webinar is an overview of the coming changes and their implications, using a new approach yet is based upon solid principles and proven practices.
Viewing this in the context of Lean Documents and Lean Configuration will provide clarity prior to embarking upon these changes.
Areas Covered in the Session :
Brief introduction to Lean Documents and Lean Configuration
ISO 13485:2015 versus ISO 13485:2003
Overview of ISO 13485:2015
Systemic Requirements
Management Requirements
Resource Requirements
Realization Requirements
Remedial Requirements
Changes to ISO 13485:2015
Regulatory requirements
Risk-based approach
Medical device file
Record keeping
Product realization
User training
Design and development
Purchasing
Process validation
Servicing
Complaints
Delivery of nonconforming product
Improvement
How to apply the principles of lean documents and lean configuration provide a unique approach to creating continuity between the various elements of the Quality Management System (QMS) while avoiding unnecessary complexity and redundancy.
Bringing it all together
Who Will Benefit:
A must attend webinar for all Managers, Supervisors, Directors, and Vice-Presidents in the areas of:
Research & Development
Design Assurance
Quality Assurance
Operations
Document Control
Manufacturing Engineering
For more information and enquiries contact us at
Compliance Trainings
5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada
Customer Support : #416-915-4458
Email : support-AT-compliancetrainings.com
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