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  HUM-MOLGEN -> Events -> Courses and Workshops  
 

How to Comply with both in the Same Organization

 
  December 05, 2017  
     
 
Netzealous LLC DBA - Compliance4All, Online
2018-02-16


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


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: Event Manager
Invited Speakers:
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.
 
Deadline for Abstracts: 2018-02-15
 
Registration:

Full Details & Registration Link:

http://www.compliance4all.com/control/w_product/~product_id=501688LIVE?channel=molgen_Feb_2018_SEO 

E-mail: support@compliance4All.com
 
   
 
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