Performance & Innovation
Practical Computerized and Automated System Validation
Two Days Training Session By discussing Patient Risk-based Approach, this Training session focuses on developing
Introduction to USFDA 21 CFR Part 11
The 21 cfr part 11 applies to records in electronic form that are created, modified,
Travailler dans un environnement BPF
Objectifs: Revoir les réglementations récentes BPF applicables aux produits cosmétiques, de santé naturels, pharmaceutiques, et
Lean Management et Lean Six Sigma Ceinture Blanche
Objectifs: Comprendre les bénéfices de cette méthode reconnue, maîtriser le rôle et les responsabilités de
Best Practices of Quality Risk Management
Quality Risk Management (QRM) principles require the evaluation of risk to patient safety and product
Practical HACCP for Drug and Food Safety
This 4-hour interactive online workshop will enable participants to develop practical knowledge of the principles
Digital & Computerized System Validation
The V-model has become a standard worldwide methodology for the validation of digital and computerized
Risk-based Continued Process Verification
Objectives: The third phase of the process validation life cycle, continued process verification, is the
Successful Implementation of Data Integrity
Successful Implementation of Data Integrity into Pharmaceutical Quality System – In recent years, US FDA, MHRA,
Production Value and Overall Equipment Effectiveness
Overall Equipment Effectiveness (OEE) is a well-established KPI metrics to measure the equipment effectiveness. OEE
Introduction to EU GMP Annex 11
The EU GMP Annex 11 applies to all forms of computerized systems used as part
Fundamentals of Health Canada Annex 11 to GMP Guide
Objectives: Health Canada Annex 11 to GMP (GUI-0050) applies to all forms of computerized systems