Hi David, Congratulations, and well done on this. To any future employers, David covered the following areas during this programme: - Introduction – to pharmaceutical, (bio)pharmaceutical manufacturing in a GMP (Good Manufacturing Practice) regulated environment, quality systems, regulation and validation - Industry regulations and guidelines for GMPs – including, FDA GMPs for the United States, EMA GMPs for European Union, ICH, and PICs GMP regulation - FDA medical device rules – medical device regulations & and guidelines - GMPs vs ISO 9001:2015 – what’s the difference and why we use both - Process validation and documentation – design and verification of manufacturing systems - Key manufacturing technologies – such as organic chemical synthesis, biopharmaceutical manufacturing, tablet manufacturing and aseptic and sterile manufacturing - Supporting technologies – such as purified water generation, storage and distribution, clean steam, water for injection, storage and distribution - Introduction to Quality Risk Management (QRM) – and the importance of risk management and the basic steps involved in its application - Working in a cleanroom environment – layout, classification, gowning and monitoring - Professional Writing Skills Program – This will guide you through the assignment writing process and equip you with the written communication skills you need for working in the industry And as part of part of his end-of-module assignment, David completed a 1200-word report on the cGMPs that are required to consistently manufacture safe medicines, vaccines and medical devices for patients. It included: - The key requirements of a quality management system - The cleaning validation sequence and how to determine cleanliness levels - The documentation of a complete risk management process in terms of identifying risk, analyzing risk, evaluating risk and controlling risk. - The typical equipment and process stages used in the manufacture of active pharmaceutical ingredients - The generation, storage and distribution of pharmacopoeia grade Purified Water (PUW). - The common cleanroom configuration and airflow direction that governs personnel and material flows in a biopharmaceutical manufacturing environment Well done again.
Thank you Geraldine and co. for all your help. Geraldine Creaner Donagh Fitzgerald
