Negative customer feedback about the performance or safety of a medical device is a strong indicator of whether a company has its manufacturing process under control. This feedback is therefore subject to many requirements of both the QSR and ISO 13485. The lack of follow-up of medical device complaints is one of the most frequently cited observations in FDA-483.

This video shows how best to document customer feedback, what constitutes a complaint and what to do with "non-complaint" feedback. It also offers a suggestion for incorporating complaint trends into your company's CAPA program. It also reviews the application of risk management to a complaint handling system and explains a specific risk management system.

This video provides an overview of FDA requirements for approval/marketing of a biosimilar (generic biologic) product. The webinar covers testing requirements for biosimilar products (clinical and nonclinical) and the approval process for biosimilars.

The video also covers the relevant regulatory/scientific/qualitative principles and the three FDA biosimilar guidelines. In addition, the FDA's step-by-step approach and FDA Totality of the Evidence concepts are discussed.

For further information contact –

Organization: NetZealous BDA GlobalCompliancePanel
Website: http://www.globalcompliancepanel.com/
Email: [email protected]

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