Total Results for tag qsr: 10
Creating a Good Design History File (DHF) for Audit Success
This webinar will cover the basics on how to maintain a good Design History File that will help a manufacturer during a regulatory compliance audit.
2-day In-person Seminar: CAPA Systems for Medical Device Manufacturers
This interactive two-day course provides the tools you need to develop and implement an effective medical device CAPA system
How do I Keep FDA Happy with my Contract Manufacturer
This webinar will cover techniques and process that can help you assure reliability and consistent quality from your suppliers or contract manufacturers. You will learn how to monitor...
Equipment Calibration in FDA QSR – Regulations and Warning Letters
Instructor: Daniel O Leary This webinar explains concepts required for a calibration program that satisfies FDA’s Quality System Regulation (QSR), ISO 13485, and ISO 9001. It defines the...
Medical Device Process Validation - Statistical Aspects RAPS Approved. Earn 1...
The FDA QSR requires device manufacturers to validate processes when the manufacturer cannot "fully verify the output".
FDA Medical Device Regulation for the Beginner
This 3-hr virtual seminar will provide an introduction to FDA’s Regulation of Medical Devices and is intended for the Beginner. It will cover device classification, the device...
Acceptance Activities in FDA QSR – Regulations and Warning Letters
Instructor: Daniel O Leary This webinar will explain the FDA QSR requirements for acceptance activities related to medical device manufacturing. It clarifies FDA’s intent using the...
How to Establish A Medical Device Quality System
This 6-hr virtual seminar will present a detailed overview of regulatory requirements necessary for establishing a medical device quality system in the US, which is relevant and...
Supplier Evaluation and Assessment - FDA QSR and ISO 13485 Requirements
Instructor: Jeff Kasoff Detailed review the QSR and ISO requirements for supplier evaluation and assessment, and cost efficient options to many of the common practices. Why Should You...
Document Approval, Control, and Distribution: How to Meet FDA QSR and ISO 134...
Instructor: Jeff Kasoff This presentation will review the QSR and ISO requirements for document control, and provide a streamlined process for document control. Document control can be a...