FDA Audit and Inspections Regulatory Compliance Training - Live Webinars, Recordings & CDs

In this Good Laboratory Practices training on FDA warning letter learn how to avoid making the same mistakes in your study and to avoid having your company's name publically cited for inspection findings.

In this seminar, you will learn how to document unexpected situations accurately and completely. Are your investigations done haphazardly or in an inconsistent manner? Are your reports hard to understand? Is the discrepancy resolution process slowing your product release efforts unnecessarily?

An assessment of your people to determine who should be talking with the FDA and most importantly, who should not must be performed. This webinar will provide the process map for the compliance and quality staff to build their strategy and plans for preparing for and executing their preparation work for a PAI in the Pharmaceutical and Biotechnology world.

This program outlines a system for preparing for an unexpected inspection and details SOPs that should be established in advance of the appearance of an inspector at your front door. This Webinar will provide valuable assistance to all regulated companies that face unscheduled inspections by regulatory agencies.

To follow the regulations is Good Clinical Practices (GCP) and common sense. To not know and follow these regulations is folly. This Webinar will provide invaluable assistance to investigators and staff with regulatory/ legal responsibilities. It also delves into the complex ethical considerations in pharmaceutical product (drug or device) research involving human subjects.

This webinar will walk you through the elements you should plan for, the timing and the logistics of who should do the various components in preparation for the inspection.

A proven process for investigators will be presented to address common deficiencies with respect to costs associated with clinical investigator site requirements for studay conduct.

his presentation will cover auditing and management techniques in relation to purchasing control compliance. Real supplier auditing processes and other management tools associated with purchasing controls will be discussed Many firms feel that they are adequately auditing and managing suppliers, yet find they are having myriads of quality issues. FDA and other auditing organizations are going to focus on supplier auditing compliance in 2007-2008

This FDA compliance webinar provides FDA’s current thinking on modernizing the regulation of quality and manufacturing science through establishment of a new regulatory framework.

It will provide an overview of the FDA inspection process in general along with a background and understanding of the role played by the Agency, its administrative and enforcement powers Pharmaceutical, biotech, medical device and generic drug companies will be most interested in attending this program. The seminar teaches important tips on how to prepare for and handle FDA and related regulatory inspections.

This FDA quality inspection training will focus on FDA’s current thinking on cGMP requirements, including background information on FDA’s inspectional requirements under the Food, Drug and Cosmetic Act. The Food and Drug Administration is using a new approach to inspections as a part of their cGMP Initiative for the 21st Century

This FDA Inspection training is designed to provide the tools and practices necessary to effectively prepare for and manage a successful FDA inspection.

This FDA Inspection will discuss FDA inspection readiness techniques and how to prepare your organization for a facility inspection.

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).