GlobalCompliancePanel

Creating an effective Product recall process that will protect both the consumer and company's/brand's reputation requires careful planning and active involvement of each involved department

This webinar will examine the existing and proposed requirements for the FDA's DHF - including its derivative documents, the DMR and DHR.

Although the concept of test method validation is based on good science, the expectation that test methods in the pharmaceutical industry be validated was established by the USP in the 1980s

FDA issued a guidance document covering GMP requirements for Phase 1 products. These guidelines remove some of the problems that are encountered with early phase products and are in addition to those that cover the CMC sections for IND submissions

In this session we will discuss the HIPAA audit and enforcement processes and how they apply to covered entities and business associates.

If you handle any electronic patient information, don’t miss this teleconference on compliance with the extensive requirements for policies and procedures in the HIPAA security regulation.

In this session, attendees will learn what the PCI DSS requires for protection and how the PCI DSS relates to the HIPAA Security Rule - there are substantial similarities, and being prepared for one helps you prepare for the other,

This session will present the background of the regulations that call for information security risk analysis and show how it fits in to an overall information security management process.

The principal objective in a new drug development program is to assess the benefit / risk ratio.

This webinar will provide an overview of process validation for devices and pharmaceuticals.