Best practices compliant with the FDA regulations

Description:
Medical device manufacturers, device user facilities, and applicable stakeholders are required to establish and maintain adequate procedures for handling complaints.
This webinar is intended to help you get familiar with the regulatory requirements and how to establish and maintain an effective complaint handling system applicable to all device types.

Implementing an effective complaint handling system is of paramount importance to the device manufacturers and the stakeholders and will help to save significant amount of time and efforts in business while ensuring the safety and effectiveness of your medical device products.

This webinar will discuss the applicable regulatory requirements and how to establish and maintain the adequate procedures for handling complaints.

This 60-min webinar will help you get familiar with all the elements that are necessary to achieve compliance and to remain compliant with the FDA complaint handling regulations.

Objectives of the presentation:
Legal authorities (statutes and regulations) and definitions
Regulatory requirements and compliance
Implementing applicable processes and procedures
What to do when a complaint is received
What/how/when to investigate a complaint
Contents of records of investigation
How to adjudicate the complaint
Implementing interactive systems between complaint handling, medical device reporting, and CAPA
Numerous case studies
Lessons learned

Who can benefit:
CEOs
VPs
Compliance officers
Attorneys
Complainant managers
Managers (RA, QA/QC, CA)
Consultants
Contractors and subcontractors

Date: 07 November 2012
Time: 10:00
Venue: online, San Francisco
Cost: 243

More info:

38868 Salmon Ter, Fremont
California 94536