FDA Documentation and IT Regulatory Compliance Training - Live Webinars, Recordings & CDs

The mutually exclusive roles for Quality Assurance and Quality Control in validation will also be discussed. Across 20+ years of global regulations and guidance related to computer systems, there are four common themes that provide the foundation for auditable validation efforts.

This 21 CFR Part 11 training/webinar will provide valuable assistance to all regulated companies that need to comply with 21 CFR Part 11.

This Part 11 - Electronic Records webinar will provide an insider’s view FDA’s current thinking regarding the scope and application of Part 11 of Title 21 of the Code of Federal Regulations; Electronic Records; Electronic Signatures (21 CFR Part 11).

This FDA compliance training will review the FDA Software Standard "General Principles of Software Validation". The process that FDA investigators use relative to software failure investigations will also be discussed.

In this Risk Based Validation training we will go through various scenarios and recommend actions for validation and other controls.

This Computer system training will discuss strategies and provide tools for FDA compliance when managing change and version control of planned and unplanned changes.

This training will focus on the regulatory requirements for a Corrective and Preventive Actions (CAPA) system. Attendees will learn how to develop an effective CAPA system.

This webinar will discuss the common deficiencies in relation to compliance and validation issues that typically found with pharmaceutical Quality Control labs.