Learn how to prepare for accelerated manufacturing of your Drug Substance. This course is designed to give Production, Quality Assurance (QA), Quality Control (QC) and technical services staff detailed insight into the challenges of producing, controlling and testing biotech and biological pharma products. It challenges the way current manufacturing is performed and allows delegates to appreciate the specific design, controls and monitoring required for ensuring bioprocesses are executed right the first time. These topics are explained in terms of the resources needed for each of the key bioprocesses, key systems and commonly required services such as outsourced services and material management.
On completion of this course, delegates will know and understand:
Our training helps delegates learn how to:
The course provides insights on how to interpret the requirements of both the EudraLex Volume 4 (Annex 2) and the U.S. cGMP.
It is designed for Production / Operation, QA, QC and technical services staff as well as trainee/practicing Qualified Persons, employees to broaden their knowledge in commercial manufacturing. Ideal for businesses looking into moving from development to commercial manufacturing or businesses that are looking into improving their manufacturing and release processes.
Quality Directors, Quality Assurance Managers, Quality Assurance specialists, Quality Operation team leaders, Qualified Persons, Quality Control Managers, Lab Heads, QC Scientists, Production Directors, Production Managers, Production supervisors, Production team leaders, MSAT, Supply Chain Managers, Retail Experts.
Manufacturing, Quality Control, Quality Assurance work experience, working in the pharmaceutical industry either development or commercial environment.
This course is available as an In-House Training course. Let us know if you wish to customize a course or if you are a large group with the same requirements.
Leading specialist with long experience of training are guiding you through regulations, guidelines, interpretations, requirements and applications.
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