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

In this ISO 9001:2000 Training Understand the ISO 9001:2000 standard requirements for 1st, 2nd and 3rd part audits.

This training program will provide attendees with a better understanding of how the FDA conducts their audits and the areas of most focus. In addition, it provides a summary of common GMP deficiencies given to drug manufacturers, to use to evaluate one’s own practices. Finally, when given a regulatory audit finding, this webinar will review the top five items to remember when submitting your responses to them to avoid further questions.

This webinar will discuss the evolving regulatory requirments for testing Biologics injectibles for sub-visible Particulates.

This training program will focus on instructing attendees on best practices for buying COTS (Commercial Off-The-Shelf) software and to evaluate a software vendor. It will also highlight key data and systems subject to Part 11, and list requirements for IT, SaaS, and cloud hosting.

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.

This training program will identify data and systems subject to Part 11 and Annex 11. It will also decode what the regulations mean and illustrate the current computer system industry standards for security, data transfer, and audit trails.

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).