Complaint Handling in Compliance with FDA and ISO Regulations

This training will show how you can handle customer complaints in compliance with FDA and ISO Regulations. We will discuss the best ways to document customer feedback, what constitutes a complaint, what do with "non-complaint" feedback, and how to include complaint trending into your firm’s CAPA 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

Instructor Profile:

Jeff Kasoff, RAC, is the Director of Quality at Medivators, a leading manufacturer of endoscopy consumables and instrumentation. In this position, Jeff is responsible for oversight of the quality system, including the CAPA program, and is the liaison with FDA. For the previous 13 years, Jeff served as Director of Regulatory Affairs at Life-Tech, Inc., in which capacity he was similary responsible for quality system oversight. Jeff began his regulatory career as the first full-time employee of Optex Biomedical, a device start-up, where he initiated their regulatory policies and procedures and prepared their submissions. Jeff received his Regulatory Affairs Certification in 1996.