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

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 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This webinar will discuss the main issues with FDA’s revised draft guidance on submission of quality metrics data. It will also cover the most common observations that the FDA issues within the warning letter and how these can impact your organization.