Course description
Introduction to Biological and Biotech Drug Substances Including ATMPs - QP Module
This introductory course gives you a unique introduction to the key cGMP expectations associated with the manufacture and QC characterization of biological and biotech-derived drug substances.
You will gain key insights into the process design, control and verification expected in complex bioprocessing trains and see them in operation during a visit to a commercial biotech manufacturing facility. Delegates will have the opportunity to meet EU Qualified Persons, see the processes in action and discuss the key steps that assure the critical quality attributes of a low bioburden, formulated drug substance. This course provides you with insight and expertise into EU GMP Volume 4 Annex 2, U.S. FDA cGMP expectations, the emergence of advanced therapy medicinal products and the key process parameters that need to be in place to ensure consistency and quality.
This course is approved by the Royal Society of Chemistry as suitable for its members’ continuing professional development.
Key Learning Objectives
As biological and biotech products become ever more diverse and complex, and cost pressures more acute, the pharma manager needs a keen appreciation of risk factors, design, control and monitoring of the drug substance process. This course allows delegates to differentiate between natural variation and risk across a range of bioprocesses, indicating the most appropriate and proportionate actions to take to mitigate any areas of concern.
You will be provided with an overview of the regulatory framework surrounding bio drug substance and be given practical guidance on the key responsibilities of the Qualified Person when approving providing a disposition and risk management service.
You will also learn:
- How to meet ICHQ, EU GMP Volume 4 (including Annex 2) and FDA cGMP expectations
- The key differences between bioprocessing and chemical synthesis
- The methods of segregation, cleaning and cleaning verification associated with a multi-product biomanufacturing unit
- How to manage change and deviations during the key bioprocessing stages
- How to audit and provide QA oversight of bio facilities
- How to audit and provide oversight of remote or contract manufacturing capabilities
This course also allows you to make informed decisions when faced with a range of GMP non-conformances during bio processing.
Upcoming start dates
Training Course Content
For biological and biotech-derived drug substances, the course includes:
- Common process steps and their effect on the quality of the final drug substance
- EU and U.S. regulatory requirements
- Comparison and contrast of drug substance facilities
- How GMP is implemented across the key production processes from seed lot/cell bank to final formulation of the low bioburden bulk drug substance
- Common sources of GMP non-conformance and adulteration or misbranding
- Visit to state-of-the-art facilities and discussions with on-site pharma professionals
Why choose NSF International, Health Sciences
Trained over 1,300 delegates on our CQI and IRCA certified GMP PQS lead auditor training course
Provided expert health sciences training for over 30 years
More people have become ‘Qualified Persons’ in Europe through our training programme than any other training provider
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Expenses
Multiple participant and early bird booking discounts available. Discounts also offered to NHS staff, regulators and charities.