This program will provide an understanding of which policies, procedures and systems need to be put in place to implement and maintain compliance with the 13485 standards and some of the key advantages to an ISO 13485 certification

In this program you will learn about the regulations and standards associated with cGLP, the fundamental requirements of cGLP and the consequences of non-compliance for regulated laboratories.

This program will cover data integrity, electronic records & signatures, paper records and the compliant operation of GxP Computerized Systems to provide the tools to implement proper controls to ensure the integrity throughout the data lifecycle.

This program will examine the process of preparing and applying for the Medical Device Single Audit Program (MDSAP). It is written from the perspective of the device company that is considering joining or in the process of joining the program.

A significant part of the FDA pre-approval process remains inspection actions by the agency to ensure quality, consistency, and safety. This program will ensure you have the tools to be audit ready for these inspections.

In this program you will learn how to identify deviations, how to train your personnel on deviation management, how to keep your deviations up-to-date,how to communicate your deviations and also how to close a deviation.