Oct 17, 2022 | Cosmetics, Drugs, EASeNews, Foods, Issue of the Month, Medical Devices
Prevention of product contamination through an Environmental Monitoring Program is a requirement across FDA regulated industries. This ensures product safety and reduces the likelihood of an adverse event(s) for the consumer. An established EMP is required by FDA as part of a Good Manufacturing Practice (GMP) quality system.
Jul 3, 2022 | Cosmetics, Dietary Supplements, Drugs, EAS in Action, EAS in the News Cosmetics, EAS in the News Dietary Supplements, EAS in the News Drugs, EAS in the News Medical Device, EASeNews, Medical Devices
EAS Consultant, Tamika Cathey, is featured in Tablets and Capsules magazine with an article on establishing an effective environmental monitoring program. Contamination is costly, with recalls and fines for problematic products in the hundreds of millions. EAS offers...
Jan 1, 2019 | Dietary Supplements, EASeNews, Issue of the Month
By Tamika Cathey Specifications Development, as defined in FDA’s Good Manufacturing Practices for dietary supplements (21 CFR §111) have posed one of the biggest challenges to industry since the inception of the requirements in June 2007. Specifically, 21 CFR §111.70...
Dec 19, 2018 | Who’s Who at EAS
Tamika Cathey consults with an international client base on regulations pertaining to safety and quality of pharmaceuticals and dietary supplements. She evaluates client compliance readiness by conducting audits, risk assessments and mock FDA/GMP investigations and...
