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How to Comply with both in the Same Organization

Event Details

How to Comply with both in the Same Organization

Time: February 16, 2018 from 10am to 11:30am
Location: Online
Street: 161 Mission Falls Lane, Suite 216,
City/Town: Fremont
Website or Map: http://www.compliance4all.com…
Phone: Event Manager
Event Type: online
Organized By: Adam Fleaming
Latest Activity: Dec 5, 2017

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Event Description

Overview:
This ISO 13485:2016 webinar is a standard for Quality Management
Systems of medical device manufacturers and suppliers, and is used
worldwide for developing and maintaining the system that caters to the
needs of the market requirements for medical devices.

Why should you Attend:
For people in the medical devices industry which either develops or
planning to market medical devices to USA and Europe and plan to
implant a QMS that complies with both regulatory authorities and ask
themselves how to do it correct and efficiently.

Areas Covered in the Session:
Introduction
Brief review of regulations and standard: status and history
ISO 13485:2016 short review
Principals
Quality management system
Management responsibility
Resource management
Product realization
Measurement, analysis and improvement

Who Will Benefit:
Medical Devices Quality Personal (QA and QC)
Laboratory Managers
R&D Researchers of Medical Devices and Combined Products
Quality Control Staff
Regulatory Affairs (RA) Staff

Speaker Profile:
Eyal Lerner is owner of ELC Consulting Services which offers the
pharmaceutical and medical devices industries support in all quality
related issues: Preparation for inspections, CAPA and RCA, quality
manual QSM, self-inspection, compliance gap analysis, 3rd party
audits, Management Review, GMP, GLP,MD: ISO 13485:2016
adjustments, DHF, DMR, V&V, 510k submission preparation and ISO
17025 and Validation.

Event Fee: One Dial-in One Attendee Price: US$150.00

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com

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