RAPS pre-approved webinar on "Complaint Handling in Compliance with FDA and ISO Regulations" from GlobalCompliancePanel
GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize a RAPS pre-approved webinar on the topic, "Complaint Handling in Compliance with FDA and ISO Regulations" on March 5. This 60-minute webinar earns up to 1.0 RAC credits towards a participant's RAC recertification upon full completion.
- San Jose, CA (1888PressRelease) March 05, 2013 - Description:
One of the most important reasons for which medical devices companies invite 483's from the FDA is failure to follow up on complaints. Complaint handling assumes great significance because ineffectiveness at it is considered an inability to address requirements set out in both QSR and ISO 13485.
This webinar is designed to help companies address this issue. It will list the requirements needed to define, document and implement a complaint handling system. It will also take up the requirements for complaint review, investigation and corrective action, as well as the ISO-specific implications these carry.
This learning session will enable participants to understand what a complaint is; what to do with a "non-compliant" feedback, and suggest methods for making complaint handling an integral part of a firm's CAPA program.
This session will cover the following topics:
- 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
When:March 5, 10:00 AM PDT | 01:00 PM EDT
By whom:
Jeff Kasoff, RAC, is the Director of Regulatory Affairs at Life-Tech, Inc., a leading manufacturer of consumables and instrumentation in the urodynamic and pain management fields. In this position, Jeff holds the critical portfolio of being responsible for oversight of corporate compliance with domestic and international regulations and preparation of submissions, and is the primary liaison point with regulatory agencies and notified bodies.
Performing such challenging tasks day in and day out has given Jeff deep knowledge of regulatory affairs, which he has imparted in the dozens of webinars he has presented in many areas dealing with regulatory compliance. Jeff received his Regulatory Affairs Certification in 1996.
For whom:
The webinar will benefit
- Regulatory Management
- Quality Management
- Customer Service Personnel
- Sales Personnel
- Quality System Auditors
- Consultants
Duration: 60 minutes
To enroll for this webinar, contact
webinars ( @ ) globalcompliancepanel dot com
Ph: 800-447-9407
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