Webinar on Design Verification, Validation and Testing for Medical Devices

Website https://compliancetrainings.com/product/design-verification-validation-and-testing-for-medical-devic | Edit Freely

Category FDA Compliance, Food, Drugs & Biologics, Medical Devices

Deadline: January 26, 2017 | Date: January 26, 2017

Venue/Country: Online, Canada

Updated: 2016-12-19 22:35:58 (GMT+9)

Call For Papers - CFP

You will gain a thorough insight into the specific auditing requirements of the International ISO 13485 Standard requirements for medical devices. This class will truly build your knowledge from the fundamental principles and help you grow into fulfilling the regulatory requirements as a product developer, manufacturer, auditee for external FDA type of audits and serve as an internal or supplier auditor.

The webinar will also focus on the major difference in expectations between FDA Quality System Regulations and Quality System inspection Techniques (QSR and QSIT) and ISO 13485 for globally distributed products. Latest changes to ISO 13485 for additional vigilance in areas such as supplier management, risk management and training will be discussed.

Areas Covered in the Session :

Requirements of ISO 13485

How to carefully attend to every aspect of the related biomedical standards

Document control

Purchasing Controls

Production controls

CAPA

Identification and Traceability

Changes to ISO 13485

How ISO 13485 differ from FDA QSR 21 CFR 820 requirements

Regulatory expectations of other major growing geographies in the world

Who Will Benefit:

A must attend webinar for Managers, Supervisors, Leads, Specialists, Engineers and Groups in Department of:

Quality Assurance

Regulatory Affairs

Research & Development

Quality Control

Supplier Management

Documentation

Production

Internal Auditors

Quality Auditors

Supplier Auditors

Operations

Manufacturing

Suppliers to medical device industry