Mivado GlobalPerformance CSV/CSA Mastery Training equips biopharma professionals with practical skills to implement risk-based validation and assurance for GxP systems, blending traditional CSV rigor with modern CSA efficiency.
Advanced Biopharma Stability Program Design Two-Day Training Overview This two-day advanced training is designed for professionals in the biopharmaceutical, pharmaceutical, and medical device industries who are involved in stability program development. The program will cover key regulatory requirements, best practices for study design, data analysis, and risk management. Participants will gain the skills to design
This intensive one-day workshop provides an in-depth review of Health Canada’s Good Manufacturing Practices Guide for Natural Health Products (NHP GMP: GUI-0158), Version 4.
This one-day process validation training session is designed to provide an overview of the latest concepts in Process Validation. The US FDA and EMA have different approaches to Process Validation.
Lean Six Sigma Yellow Belt 2 days of Training Description The Lean Six Sigma Yellow Belt program is a foundational certification course designed to provide participants with a comprehensive understanding of the DMAIC (Define, Measure, Analyze, Improve, Control) methodology. Unlike deeper technical tracks, this training focuses on practical, “low-barrier” tools that can be applied immediately
Data Integrity is a fundamental principle of Good Manufacturing Practices (GMP). Over the past four years, both the FDA and European inspectors have reported numerous citations related to data integrity.
Kossi Molley, PMP, LSSBB, Chemist, Certified Trainer Two-day Technology Transfer Training Technology transfer of manufacturing processes is a critical aspect of the pharmaceutical industry. Technology transfer (TT) is an increasingly important part of the pharmaceutical industry, with companies expanding the use of third parties for both development and manufacture. There are few formal guidelines around
Principes de fabrication et d’excellence opérationnelle Les opérations constituent le processus de transformation au sein d’une série d’activités, tout au long de la chaîne de valeur, du fournisseur au client. La gestion des opérations conçoit, exploite et améliore les systèmes de la chaîne d’approvisionnement et fournit à l’industrie pharmaceutique les connaissances nécessaires pour promouvoir les
Principles of Manufacturing and Operational Excellence Operations are the transformative process within a series of activities, along a value chain extending from supplier to customer. Operations Management designs, operates, and improves supply chain systems and provides the pharmaceutical industry with a knowledge base to promote best practices and operational excellence within pharmaceutical operations management. This course is designed to
Mise en œuvre de l’assurance des logiciels informatiques (CSA) : une approche fondée sur les risques. La transition vers les nouvelles directives nécessitera de se défaire des anciennes pratiques et de réapprendre à appliquer l’assurance des logiciels informatiques (CSA). L’accent est mis sur la pensée critique, la gestion des risques, la sécurité des patients et des produits, l’intégrité des données et l’assurance qualité.
