Continuous Manufacturing Processes for Biopharmaceutical Products Description The biopharmaceutical industry is driven by the need to increase production and reduce costs while maintaining product quality and has increasingly focused on intensification of processes to accomplish this goal. The environment for recombinant proteins used as biotherapeutics is changing. In the context of developing new biological entities,
This comprehensive training program will cover the critical aspects of Process Performance Qualification (PPQ) in the pharmaceutical industry. It will delve into the regulatory requirements, scientific principles, and practical application of PPQ, ensuring participants understand how to effectively plan, execute, and document PPQ studies.
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.
Ce programme de formation complet aborde les aspects critiques de la qualification des performances des procédés (PPQ) dans l’industrie pharmaceutique. Il explore les exigences réglementaires, les principes scientifiques et l’application pratique de la PPQ, permettant aux participants de planifier, réaliser et documenter efficacement les études de PPQ.
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.Â
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