Gap Assessment per FDA & Health Canada Compliance of a Manufacturer in China, establish and deliver custom GMP Training, Computer Systems Validation (ERP, Process Control, LIMS, Formula Management)

Client Type: Cosmetics, GxP System, Software & Computer System Validation

Jurisdiction(s): USA & Canada

Services Provided: Provided pre and post FDA meeting preparation. Performed a focused audit of OOS procedures; reporting and followed by formal training of OOS handling. Completed a routine GMP audit and report. Identified automated systems and procedures used in GMP functions and conducted an audit to determine conformance to Data Integrity SOP. Completed the following activities: security, data integrity, SOP monitoring, training, system validation of QAD software, qualification and validation of GMP systems at facility.