Complaint handling in compliance with fda and iso regulations

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:. This multi-faceted experience makes Jeff uniquely qualified to address compliance issues across the entire range of company sizes. Jeff has also been primary liaison with FDA inspectors and notified body auditors, giving him first-hand experience with the most common issues surfaced by regulatory agencies.

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance.

The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. 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.

Failure to follow up on complaints about medical devices is among the most frequently cited observations on FDAs. 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.

The complaint file s must contain all complaints including those open or still under investigation. The inspection should ascertain what files are maintained that meet the definition of a complaint 21 CFR Ask the firm if it trends or performs other analyses of complaints. If no trending or problem identification is done, then the inspection should begin with a trending of the complaints.

NOTE: The actual complaints may provide leads in identifying product defects. Deficiencies in complaint handling practices may result in lost complaint data essential to identifying product defects, and possibly quality system problems, which have not been adequately corrected by the firm.

Potential environmental factors that could contribute to the failure of a device include the area of the country, weather, use factors, electromagnetic interference, vibration, shock, etc.