How to Comply with both in the Same Organization

Start Date : February 16, 2018
End Date : February 16, 2018
Time : 10:00 am to11:30 am

Phone : 8004479407
Email : support@compliance4All.com

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

Organized by

Organized by compliance4all14

Event Manager ,
161 Mission Falls Lane, Suite 216,

Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. 

Compliance4All has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements. Compliance4All offers path breaking professional training solutions to organizations that help them address pain areas and overcome the challenges and difficulties associated with meeting regulatory requirements.

Tel: 800-447-9407
Mobile: 8004479407
Email: support@compliance4All.com
Website: http://www.compliance4all.com/


Event Categories: Health & Nutrition.

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