You will be redirected to our secure system.
When you need on-site attention, we’re not just here to help, we’re there to help—right by your side.
Individual courses are remarkably effective. But sometimes when you have a specific need, it helps to have expert guidance right in the room with you and your team.
In that case, we’re happy to design a custom training for your entire team, whether online—or on-site.
Learn moreRemember – at checkout you can choose to take this course On-demand. We offer a 10% group discount when you register 2 of more attendees (up to 10). Contact us for larger groups.
In its role mandated by the FD&C Act, FDA periodically performs site inspections to ensure that Pharmaceutical and Medical Device companies are in compliance with current Good Manufacturing Practices (cGMPs). The goal of these inspections is to ensure that establishments consistently manufacture drug products of acceptable quality and minimize consumers’ exposure to adulterated drug products. Unfavorable outcomes from these inspections can result in significant financial losses for a company.
This practical 90-minute accredited training outlines the role and authority of the FDA in conducting inspections and describes the basic steps companies need to undertake in order to successfully manage these inspections.
This 90-minute accredited training will benefit those professionals in the pharmaceutical, device, biotechnology, cosmetics and related industries who will, directly or indirectly, be involved in FDA inspections.
Personnel in the following functions will find the presentation of value:
– Executive Management
– Auditing
– Training
– Quality Assurance
– Regulatory
– Engineering
– Quality Control
Renée B. Galkin
Quality Management Consultant