Medical Device Regulatory Compliance Training - Live Webinars, Recordings & CDs

This Latin America Regulatory compliance requirement training/webinar will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Latin America.

This 21 CFR Part 11 compliance training will guide you through the requirements of Part 11 and will also explain its 3 primary areas: SOPs, product features and validation (10 step risk based approach).

The manufacture of sterile products and the risk they represent to the public is always on the fore front of inspectors during regulatory audits. As a result, the manufacture of sterile products require a high degree of control of incoming materials, the manufacturing process and the control of personnel to name a few. A weakness in any of these items can jeopardize the sterility assurance of the final product. This training program will highlight and summarize the following main components relating to current validation requirements for sterile products and include the following; review of the current regulations and guidance documents, the typical expectations when aseptic processing is involved, the expectations for protocols used to document the qualification of associated equipment, utilities and processes, and recently cited regulatory deficiencies.

Each 510(k) submission poses a new set of challenges and new variations, depending on the type of device, the risk level, and its history. Therefore, it is essential to have a strong understanding of the most up-to-date 510(k) submission requirements and how they relate to your device for the most efficient submission process. This course will elaborate device classification, overview the 510(k) program, and discuss FDA submissions.

This pack of 4 courses contains some of our best selling Medical Device webinars which together cover the essential compliance challenges faced by Medical Device companies today. ComplianceOnline brings you a special Medical Devices training primer. A package of 4 of our best selling Medical Devices webinars- available at a 50% discount.This pack of 4 courses contains some of our best selling Medical Device webinars which together cover the essential compliance challenges faced by Medical Device companies today.