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Practical Computerized and Automated System Validation

Two Days Training Session By discussing Patient Risk-based Approach, this Training session focuses on developing

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Introduction to USFDA 21 CFR Part 11

The 21 cfr part 11 applies to records in electronic form that are created, modified,

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Travailler dans un environnement BPF

Objectifs: Revoir les réglementations récentes BPF applicables aux produits cosmétiques, de santé naturels, pharmaceutiques, et

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Lean Management et Lean Six Sigma Ceinture Blanche

Objectifs: Comprendre les bénéfices de cette méthode reconnue, maîtriser le rôle et les responsabilités de

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Best Practices of Quality Risk Management

Quality Risk Management (QRM) principles require the evaluation of risk to patient safety and product

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Practical HACCP for Drug and Food Safety

This 4-hour interactive online workshop will enable participants to develop practical knowledge of the principles

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Digital & Computerized System Validation

The V-model has become a standard worldwide methodology for the validation of digital and computerized

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Risk-based Continued Process Verification

Objectives: The third phase of the process validation life cycle, continued process verification, is the

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Successful Implementation of Data Integrity

Successful Implementation of Data Integrity into Pharmaceutical Quality System – In recent years, US FDA, MHRA,

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Production Value and Overall Equipment Effectiveness

Overall Equipment Effectiveness (OEE) is a well-established KPI metrics to measure the equipment effectiveness. OEE

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Introduction to EU GMP Annex 11

The EU GMP Annex 11 applies to all forms of computerized systems used as part

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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