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Advanced_Stability
By - Kossi Molley

Advanced Biopharma Stability Program Design

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

By - Kossi Molley

Process Performance Qualification

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.

By - Kossi Molley

Technology Transfer of manufacturing and packaging Process

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

M&OpEx-1011
By - Kossi Molley

Principles of Manufacturing and Operational Excellence

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

By - Kossi Molley

Implementing the Computer Software Assurance (CSA): Risk-based approach

Implementing the Computer Software Assurance (CSA): A Risk-based approach Transitioning to the new guidance will require unlearning “the old” and relearning how to apply Computer Software Assurance (CSA). The emphasis is on critical thinking, risk management, patient and product safety, data integrity, and quality assurance. Even though this guidance is being developed for the medical

By - Kossi Molley

Production des comprimés, crèmes, onguents, liquides et produits stériles

Ce programme est offert par l’entreprise Mivado Global Performance à des étudiant.e.s et travailleurs/travailleuses exerçant ou qui veulent exercer des fonctions de travail similaires dans des secteurs connexes à l’industrie des produits de santé et qui souhaitent intégrer les fonctions de travail rattachées à la profession de spécialiste en production pharmaceutique. Cet atelier de formation

By - Kossi Molley

BPF, Affaires Règlementaires et Système qualité dans l’espace UEMOA

Ce programme est offert par l’entreprise Mivado Global Performance à des étudiant.e.s et travailleurs/travailleuses exerçant ou qui veulent exercer des fonctions de travail similaire dans des secteurs connexes à l’industrie des produits de santé et qui souhaitent intégrer les fonctions de travail rattachées à la profession de spécialiste en production pharmaceutique. Cet atelier de formation