Two Day Implementing ISO 134852016 Workshop - Phoenix, Arizona, United States - January 26-27, 2017 - Research and Markets

DUBLIN--()--Research and Markets has announced the addition of the "Implementing ISO 134852016" conference to their offering.

The final version of ISO 13485:2016 is now available and companies should be planning their implementation. There are significant changes from the earlier version; they will require major modifications to the Quality Management System (QMS). The new version has better alignment with FDA's QSR, but there are still major differences that create issues for effective QMS implementation.

This workshop covers the differences from the 2003 version to the 2016 version and offers practical implementation advice to update your QMS. Participants will also learn the differences with QSR and understand how to resolve them. The workshop uses extensive examples and exercises to help clarify the concerns.

Some regulatory systems will rely on ISO 13485:2016 through the Medical Device Single Audit Program (MDSAP). The US will participate in MDSAP, but doesn't expect to change its regulations. The EU is not participating, has published its own version, EN ISO 13485:2016, and will continue with the Notified Body system. However, the EU intends to replace the directives with new regulations resulting in new versions of EN ISO 13485:2016 and EN ISO 14971:2012.

The workshop covers implications in particular regulatory systems including MDASP and its nonconformity grading system.

Agenda:

Day 1 Schedule

Lecture 1: Overview of ISO 13485:2016

- Summary of the differences between ISO 13485:2003 and ISO 13485:2016

- High level comparison with FDA QSR

Lecture 2: Regulatory Framework

- Transition period for certificates

- Canada - MDSAP v CMDCAS

- EN ISO 13485:2016 and the MDD

- The new QMS audit findings/nonconformance grading system

- Implications of the EU's Medical Device Regulations

Lecture 3: Management Responsibility

- Quality Policy and Objectives

- Responsibility and Authority

- Internal Quality Audits

- Management Review

Lecture 4: Resource Management

- Competence and Training

- Infrastructure

- Work Environment and Contamination Control

Lecture 5: Design and Development

- Design Planning

- Design Inputs and Design Outputs

- Design Verification and Design Validation

- Design Review

- Design Transfer

- Design Changes

- Design Files

Day 2 Schedule

Lecture 1: Supplier Management

- Selection

- Purchasing Information

- Written Quality Agreements

- Purchased Product Verification

Lecture 2: Production Processes

- Production Control

- Installation and Servicing

- Identification and Traceability

- Control of Nonconforming Product

Lecture 3: Process Validation

- When to Validate

- Validation Requirements

- Software Validation

Lecture 4: Monitoring and Measuring

- Control of Equipment

- Processes and Products

- Data Analysis

- Complaint Handling

Lecture 5: Corrective and Preventive Action

- Corrective Action

- Preventive Action

For more information about this conference visit http://www.researchandmarkets.com/research/pm7bts/implementing_iso

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Related Topics: Medical Devices

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Related Topics: Medical Devices