This course details the rules and interpretation of GMP for biopharma products and discusses issues and challenges with seasoned NSF experts.
The course provides insights on how to interpret and deploy the requirements of both the U.S. cGMP and EudraLex Volume 4 (particularly Annex 2). It covers the cGMP requirements for each key process step especially concerning process development, validation, control, auditing, effective quality assurance (QA) and quality control (QC).
This course is offered virtually and the training will be delivered via a combination of an instructor-led virtual classroom and self-paced learning online. Full details will be sent to you following registration.
This biotech course includes:
We explain the critical requirements of cGMPs alongside a range of bioprocesses, including:
The course also includes sessions associated with:
Want more? We have three hours of additional self-paced material that covers:
On completion of this course, delegates will know and understand:
Our biotech training helps delegates learn how to:
Attend this biotech training course if you work in operations, QA, QC, technical services or are a trainee/practicing Qualified Person, especially if you are looking to broaden your knowledge in the field or make a career transition into bioprocessing.
Robert Smith - Robert has more than 30 years’ experience in the pharmaceutical industry, in various production and quality roles for a number of major international pharmaceutical organizations. He is eligible to act as a Qualified Person under the permanent provisions for both commercial and investigational medicinal products. He is a QP assessor and Vice Chair of the Royal Pharmaceutical Society Panel of Assessors. Robert has broad experience in QA and manufacturing management gained through working with a wide range of dosage forms for both commercial and clinical supply, including solids, liquids, sterile products, vaccines, biological, biotechnology, viral vectors, gene therapy and cellular therapy products.
Ian White – Ian has broad experience of the pharmaceutical industry. Most recently he worked as an Expert GMDP Inspector for the UK competent authority, the MHRA, where he was responsible for developing and implementing technical and policy-based aspects of the Inspectorate work, to reduce risk and improve the quality of medicinal products for patients. He led deployment-based operations for the roll-out of COVID vaccines, therapeutics, and anti-viral medicines, working across both government and industry to ensure robust supply chains, develop policy and provide sound, pragmatic, quality risk-based guidance.
Multi-delegate discounts available. Discounts also offered to NHS staff and charities.
Whether you need to meet EU, FDA or other regulatory agency’s needs, this course provides the knowledge, skills and tools to succeed.
This risk management training improves your problem solving and decision-making skills during the manufacturing process of sterile products.