GMP Consultants Inc.
FDA is hosting a 3-hour webinar on Electronic Submission of Adverse Event Reports to FDA Adverse Event Reporting System (FAERS) using International Council for Harmonisation (ICH) E2B(R3) Standards on November 7, 2023. The purpose is to provide the pharmaceutical industry…
FDA is hosting a webinar on Electronic Systems, Electronic Record, and Electronic Signatures on April 25, 2023. This is your opportunity to get information on FDA’s thinking regarding 21 CFR Part 11 and its application to electronic systems, records and…
One of the many activities performed by GMP Consultants is Auditing. We average 10 – 12 audits / year. We have experts that are qualified to audit sterile and non-sterile drug manufacturers, APIs, packagers, labelers, testing laboratories, importers, distributors and…