GlobalCompliancePanelto organize webinar on "Complaint Handling and Management: From Receipt to Trending"
GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize a webinar on the topic, "Complaint Handling and Management: From Receipt to Trending", on January 15.
- Fresno, CA (1888PressRelease) January 15, 2013 - Complaint handling is a crucial aspect of a Quality System. Complaint handling consists of receiving a complaint about a product, evaluating it, and resolving it. If necessary, the complaint should also be investigated and analyzed.
One aspect of complaint handling is that it should lead to a conclusion about whether the complaint was a valid one or not. The other aspect is that consistent complaints should lead the manufacturer of medical devices to the root cause of the process. They should make way for analysis and introspection. Complaints should lead to serious root cause analysis. They should give manufacturers a clear indication of the problems consumers face in relation to design, use and manufacture of the product.
Getting a series of complaints over a fairly extended period of time should lead to analysis which will help the firm spot a trend. This trend will open the way for incisive root cause analysis of wherever the problem could lie in the product chain -manufacture, labeling, packaging or distribution. This webinar will give participants an overview of the best practices in complaint handling and regulatory expectations for medical devices and pharmaceutical products. It covers the following areas:
o Understand how and why CAPA is tied in to product complaint investigations
o Examples of tools currently being used to conduct investigations
o How far and in-depth do you go with your investigations
o What are current FDA "hot" buttons and trends
o Benchmarks and best practices for investigations
o How to become a "good" investigator and the emphasis on closed-loop investigations
o Why risk-based approaches are vital to the decision-making process
o How to improve and bullet-proof your product complaint management system with investigations
When:January 15, 10:00 AM PDT | 01:00 PM EDT
By whom:
David R. Dills, Independent Regulatory & Compliance Consultant, worked for PAREXEL Consulting till July 2008, when he had to leave due to a service line organizational shakeup. Prior to joining the consultancy, Mr. Dills provided independent consultative services in various capacities from pre-marketing to post-marketing within the technical, quality, regulatory affairs and compliance arena to pharmaceutical, Class I/II/III medical devices, in-vitro diagnostics and biologics/biotech companies with an emphasis on establishing sustainable compliance systems.
David currently serves on the Faculty Advisory Board for the Pharmaceutical Training Institute and Editorial Advisory Boards for Software Quality Professional and the Institute of Validation Technology (IVT), publisher of the Journal of GXP Compliance and Journal of Validation Technology. He also serves on the Readers' Board for Medical Device & Diagnostic Industry and Medical Product Manufacturing News and as Advisor for the ASQ's Section 1506. He is a former Chair and Co-Chair and an active member of the Biomedical Division, RAPS, PDA, ISPE, and other industry working groups.
David has authored and published validation, regulatory and compliance-related articles, commentaries and technical guides, and is an accomplished global industry presenter.
For whom:
The webinar will benefit
o All levels of Management for all departments and those who desire a better understanding
o QA/QC/Compliance/Regulatory Affairs
o Marketing & Sales & Customer Service
o Engineering/Technical Services
o Consultants
o Operations and Manufacturing
Duration:90 minutes
To enroll for this webinar, contact
webinars ( @ ) globalcompliancepanel dot com
Phone: 800-447-9407
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