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...
Температурно картографиране

Температурно картографиране

Регистрация ЦЕЛ Eднo oт ocнoвнитe изиcĸвaния нa дoбpaтa пpoизвoдcтвeнa и дистрибуторска пpaĸтиĸa при лекарствените продукти за хуманната медицина e да се гарантира, че параметрите за температура и влажност на средата за съхранение и транспорт отговарят на изискванията...
Regulatory updates on Good Distribution Practice (GDP)

Regulatory updates on Good Distribution Practice (GDP)

Registration form BACKGROUND Supply chains are becoming increasingly complex, and regulations concerning the quality of products and services are becoming more complicated. Organizations are thus under increasing pressure to demonstrate their commitment to demonstrate...