Live webinar on Best Practices for Complaint Handling in Compliance with FDA and ISO Regulations By Compliance2go

Sign for Notice Everyday

Home Post Event 2025Event 2026Event By Topic By Country Contact

Our Sponsors

Live webinar on Best Practices for Complaint Handling in Compliance with FDA and ISO Regulations By Compliance2go

Website https://compliance2go.com/index.php?option=com_training&speakerkey=15&productKey=129 | Edit Freely

Category Training, web seminar,FDA,Japan,EU, pharmaceutical and biologic products, Life Science Industry, CE Marking, Medical Device R&D, Clinical research and medical operations

Deadline: July 25, 2012 | Date: July 25, 2012

Venue/Country: houston, U.S.A

Updated: 2012-05-26 02:39:32 (GMT+9)

Call For Papers - CFP

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

Webinar Includes:

-Q/A Session with the Expert to ask your question

-PDF print only copy of PowerPoint slides

-60 Minutes Live Presentation

Who will benefit: The designations

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

About Speaker

Jeff Kasoff, RAC, is the Director of Quality at Byrne Medical, a leading manufacturer of endoscopy products. In this position, Jeff is responsible for supplier management, during which he oversees supplier management, CAPA, and document control. Prior to this, Jeff spent 13 years at Life-Tech as the Director of Regulatory Affairs, where he was responsible for regulatory compliance of all aspects of the quality system. Jeff received his regulatory affairs certification in 1996.

Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.