Description

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: (Titles)

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

· Quality System Auditors

· Consultants

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.

Price List: Live: $189.00 One Dial In - Unlimited attendance $249 Recorded: $289.00, CD: $349.00
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