Online conference Implementing Adequate CAPA and Design Control Procedures

Website https://compliance2go.com/product/?pid=CP2014-380 | Edit Freely

Category Medical Device

Deadline: October 28, 2014 | Date: October 28, 2014

Venue/Country: Houston, U.S.A

Updated: 2014-10-16 17:47:06 (GMT+9)

Call For Papers - CFP

Device firms, who are intending to bring medical device products into the US market, are subject to quality system regulations.

Recent FDA enforcement trends (including 2013) reveal that both design control and Corrective and Preventive Action (CAPA) systems are critical elements to sustain FDA inspections.

Device manufacturers are required to establish and maintain FDA-compliant quality management systems, where appropriate and applicable, including design control and CAPA systems. This webinar is intended to provide guidance on understanding, interpreting, and implementing design control and CAPA system requirements. This presentation is further intended to help you establish and maintain adequate design control and CAPA procedures for all classes of medical devices including IVDs.

Understanding, interpreting, and implementing design control and CAPA system requirements in a holistic manner can significantly contribute to your product quality and regulatory compliance, helping to ensure your innovative medical products to be safe and effective on a global market and saving enormous amount of your unnecessary time, efforts and investment.

This 60-min webinar will provide great opportunities for you to get familiar with regulatory and quality requirements for design control and CAPA systems applicable to all types of medical devices including IVDs.

Why should you attend :

This webinar is intended to help you learn and ensure you can implement adequate CAPA and design control procedures. In addition, this webinar will provide an opportunity to better understand and adequately implement adequate design control and CAPA systems.

Areas Covered in the Session:

Applicable Laws and Regulations

Statutory and Regulatory Requirements

Introduction and Definitions

Design and Development Planning

Design Input and Design Output

Design Review

Design Verification And Validation

Design Transfer and Design Changes

Design History File (DHF), Device History Record (DHR) and Device Master Record (DMR)

Corrective and Preventive Action (CAPA)

Root Cause Analysis

CAPA Elements

Common Problems

How to Avoid Common Mistakes

Speaker’s Recommendation and Suggestions on PASS-IT Solutions

Who will benefit: (Titles)

CEOs

VPs

Compliance officers

Attorneys

Clinical affairs (associates, specialists, managers, directors or VPs)

Regulatory affairs (associates, specialists, managers, directors or VPs)

Quality assurance (associates, specialists, managers, directors or VPs)

R&D (engineers, scientists, managers, directors or VPs)

CROs

Consultants

Contractors/subcontractors

Webinar Includes:

Q/A Session with the Expert to ask your question

PDF print only copy of PowerPoint slides

60 Minutes Live Presentation

Certificate of Attendance