May 22, 2018
By Jerry Chapman, GMP Consultant and Editor-in-chief, Xavier Health
Experts at the FDA/Xavier PharmLink conference at Xavier University in March 2018 presented and analyzed the FDA's top 10 drug GMP inspection citations for FY2017 during a panel discussion. The first part of a two-part series.
May 10, 2018
By Patricia Santos-Serrao, Director of Product Strategy, MasterControl
A mock U.S. Food and Drug Administration (FDA) audit can be conducted by an internal team of employees qualified by experience in regulatory compliance or by an external team with previous FDA work experience. Incorporating routine mock FDA audits can help your organization prepare for a FDA audit as well as reduce the number of audit observations and repeat observations received from regulatory authorities.
December 19, 2017
By Marci Crane, Staff Writer, MasterControl
Before Santa can fill the stockings of good children from across the world, he and his elves must be inspected and/or audited by certified auditing bodies and similar organizations from around the world. Why? Because Santa must prove that the sweet treats he manufactures measure up to high quality standards for all children everywhere.
When an FDA inspector comes to your door, it is usually a time of stress and uncertainty. You need to handle logistical elements like where the inspectors are going to be placed, how you.
