Webinar · Palm Beach, Florida
Complaint Handling in Compliance with FDA and ISO Regulations
Health · Medicine · Pharmaceuticals
Key numbers
- Editions on record
- 1first in 2015
About Complaint Handling in Compliance with FDA and ISO Regulations
Overview:
Negative customer feedback about a medical device's performance or safety is a strong indicator of whether a firm's manufacturing process is in control. This feedback is therefore subject to many requirements in both the QSR and ISO 13485. Failure to follow up on complaints about medical devices is among the most frequently cited observations on FDA-483s.
This session will include the requirements for defining, documenting, and implementing a complaint-handling system, including the requirements for complaint review, investigation, and corrective action, as well as the ISO-specific implications. This session will discuss the best way to document customer feedback, what constitutes a complaint, and what do with "non-complaint" feedback. Also contained will be a suggested method on including complaint trending into your firm's CAPA program. Additionally, the application of risk management to a complaint handling system will be reviewed, and a specific risk management system explained.
Areas Covered in the Session:
FDA and ISO requirements for complaint handling
Establishment of complaint handling program
What constitutes a complaint
ISO-specific implications of complaint handling
The roles of investigation and corrective action in complaint handling
Complaint trending and reporting
Application of risk management to complaint handling program
Who Will Benefit:
This webinar will provide valuable assistance to all regulated companies, since complaint handling is a regulatory requirement across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:
Regulatory management
QA management
Customer Service personnel
Sales personnel
Consultants
Quality system auditors
Speaker:
Jeff Kasoff
From our listing of this edition. Details may have changed since.
Editions
| Year | Dates | Where | Exhibitors | Visitors |
|---|---|---|---|---|
| 2015 | 8 Jan 2015 | Webinar Venue Online | — | — |
Past editions from the bvents archive (2008–2019) and organiser figures where they were published.
Questions
When is Complaint Handling in Compliance with FDA and ISO Regulations?
The next dates haven't been confirmed. The last edition we have on record was 8 Jan 2015.
Where is it held?
The last edition we have was at Webinar Venue, Palm Beach, Florida.