Overview: Supplier selection and management is one of the critical issues for medical device manufacturers. Suppliers provide materials and services to the device manufacturer, which means that they can be critical to performance and delivery of your device. Neither the FDA nor your notified body regulates your suppliers (with a few exceptions). They expect you to have an effective process to ensure your suppliers perform in the regulatory env...

Course "Validation and Part 11 Compliance of Computer Systems and Data” has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. GlobalCompliancePanel Refer a Friend Program: Any Customer to 3 Referrals "Can Participate 2 Days Seminar for free of Cost Overview: Analytical equipment should be qualified and computer systems should be validated to demonstrate suitabilit...

Overview: Analytical equipment should be qualified and computer systems should be validated to demonstrate suitability for the intended use. Electronic records must comply with FDA Part 11 and EU/PICS GMP Annex 11 requirements to ensure data integrity, security and availability. Recent EU and FDA inspection documents prove that qualification, validation and electronic laboratory are records are on target of inspectors. The large number of warn...

Course: "The A to Z's of Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems” has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or tra...