compliance training 2018 - The New ISO 13485: 2016 and Comparison with 21CFR820 - how to Comply with Both in the same Organization

Overview:
Many medical devices are distributed in USA and in the European Union (EU). Each market has its own regulatory requirements which mainly focused on its quality management systems (QMS). The two QMS are described in two documents, one by the international ISO standard 13485 and the other by FDA Quality System Regulation (21CFR820).
The systems share many similar features but they are not identical. Could we have on the same site a QMS that complies with both requirements? Must we have one QMS that's complies with both, or we could have two QMS coexist on the same site? To answer it we should discuss the background of both documents, their legal status, what is expected by the regulatory authorities and some basic concepts in quality and medical devices quality in specific. We should understand what is required by both, what is just semantically named differently and what is principally different between both documents. For instance, ISO requires quality manual (QM) while such term does not mentioned in the FDA QSR but policies and standard operating procedures, this can be settled relatively easy. Other issues requires more attention. We will point out the main features and what should be done from an aspect of a site or a manufacturer which wants to comply with both QMS.
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
FDA QSR (21CFR820) short review
Quality System Requirements
Design Controls
Document Controls
Purchasing Controls
Identification and Traceability
Production and Process Controls
Acceptance activities
Nonconforming Product
Corrective and Preventive Action
Labeling and Packaging Control
Handling, Storage, Distribution, and Installation
Records
Servicing
Statistical Techniques
Comparison between both QMS
Common features
Variances between both
Terms/ vocabulary
Comparison between terms
Summary
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 (internal audits), compliance gap analysis, 3rd party audits (FDF and API's), Management Review, GMP, GLP,MD: ISO 13485:2016 adjustments, DHF, DMR, V&V, 510k submission preparation and ISO 17025 (lab accreditation) and Validation. Eyal worked for the Israel National Accreditation Authority (ISRAC) as head of accreditation of chemistry and Biology and later on as audits director in Teva pharmaceuticals global quality unit. Eyal preformed more than 100 audits in various facilities around the world as a lead auditor and auditor.
Event link : http://www.compliance4all.com/control/w_product/~p...
Contact Details:
NetZealous LLC, DBA compliance4All
Phone: +1-800-447-9407
Email: support-AT-compliance4All.com