Duration: 4 days
This four-day course provides participants with an introduction in to the key design, controls and monitors associated with the common biotech process steps; the basic science and typical process controls associated with producing a high quality biological or biotech drug substance; an introduction on how quality is assured across the bioprocess; and the insights/limitation of quality control testing; the benefits and pitfalls of subcontracting key steps in the bioprocess; a summary of the current hot topics in this field, in terms of regulatory censure, GMP observations and trends; how to audit a biological or biotech facility; guidance on the key concerns when acting as a EU Qualified Person or QA professional in this field; tour of a biotech facility and demonstrations; ensuring key learning objectives are met on plant.
Who should attend:
2 August 2021—5 August 2021
All our training courses are Covid safe and we have strict Risk Assessments in place to ensure our participants safety. Course fees are fully refundable should you need to cancel due to Covid. All participants are asked to have a negative Covid test prior to attending our courses.