GMP Compliance Auditing

GMP Compliance Auditing

5 and 6 November 2019 Pharmaceutical GMP Auditor Training This two-day training course covers how to effectively plan, perform, report and follow-up pharmaceutical audits against a range of pharmaceutical standards, including GMP, API GMP, Excipient GMP. BACKGROUND...
Essentials of Computer Validation

Essentials of Computer Validation

2nd and 3rd October 2019 Risk ManagementThe Elements of Computer ValidationIT Infrastructure qualificationValidation of ERP systemsData Integrity BACKGROUND The current GMP regulations and guidelines (ICH Q9, GAMP®5, EU GMP Guide Annex 11 “Computerised Systems“) focus...