Course description
GMP for Biological and Biotechnology Products
NSF delivers the GMP for Biological and Biotechnology Products course from the National Horizons Centre (NHC) and Teesside Universitys Centre for Professional and Executive Development in Darlington over four full-day sessions on 2-5 August 2021.
Our course is unique in content and delivery, with opportunities to see for yourself how biomolecules are produced, tested and kept in line with internationally recognized cGMP requirements. You will discuss vital issues and challenges with seasoned NSF experts in the field and cutting-edge scientists at the NHC.
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 is designed for operations, QA, QC and technical services staff as well as trainee/practicing Qualified Persons, especially those looking to broaden their knowledge in the field or make a career transition into bioprocessing.
With five hours of time on plant and accessing virtual reality tools, plus time for discussion with seasoned experts from NSF and NHC, this is a unique opportunity to learn the theory and deployment of cGMP as applied to modern biopharma processing. Incorporating case studies, regulatory references, facility demonstrations and problem-solving workshops, the course is highly innovative and interactive.
Course Tutors
John Johnson - Vice President at NSF, John has vast experience in preparing sites for regulatory GMP inspections, preparing or remodelling biopharma and steriles facilities, installing quality systems and helping companies embed the right culture for long-term sustainable growth. A passionate educator, John has a track record of improving service and margin to ensure perpetual GMP inspection readiness.
Emma Ewins - Emma has over 20 years of experience in pharmaceutical operations management, technical services and QA, gained working for international pharmaceutical organizations.
Guest Speakers from NHC Dr. Muhammad Safwan Akram and Prof. Gary Montague
About the National Horizons Centre
The National Horizons Centre at Teesside University is a £22m state-of-the-art, purpose-built bioscience facility offering research, education and collaboration for the bioscience industry. The NHC brings together industry, academia, talent and world-class facilities to drive innovation, including the application of digital technologies to improve performance and productivity.
NHC has implemented all UK government advice to ensure the well-being of delegates, in line with COVID-19 restrictions and current guidance in place.
Upcoming start dates
Suitability - Who should attend?
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.
Outcome / Qualification etc.
On completion of this course, delegates will know and understand:
- The common stages in the mammalian and bacterial bioproduction processes
- How to verify the effectiveness of each bioprocess stage via online and offline monitoring and testing
- The critical challenges associated with bioprocessing in terms of vulnerability, risk assessment and process control
- How to design the pharma quality system around the requirements of the biomolecule
Our biotech training helps delegates learn how to:
- Identify the key differences in bioprocessing compared to chemical synthesis of small molecule drug substances
- Feel confident in making the right decisions at the right time with the right information when faced with the common challenges or GMP deviations associated with bioprocessing of drug substances
- Identify what should appear in batch documentation associated with the key bioprocessing steps
- Generate a risk-based, targeted audit agenda, and be aware of the requirements in the EudraLex GMP Volume 4, Annex 2
- Delegates also become better equipped at adding value to commissioning, qualification, validation, production, operational QA and GMP auditing on-site and across fragmented global supply chains.
Training Course Content
This biotech course includes:
- 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 to how quality is assured across the bioprocess and the insights/limitation of QC testing
- The benefits and pitfalls of subcontracting key steps in the bioprocess
- A summary of hot topics including regulatory censure, GMP observations and trends
- Guidance on the key concerns when acting as an EU QP or QA/production/technical services professional in this field
We explain the critical requirements of cGMPs alongside a range of bioprocesses, including:
- Seed/cell banking
- Serial and bulk cultivation
- Harvesting
- Centrifugation
- Viral inactivation
- Chromatography
- Ultrafiltration
- Protein concentration
The course also includes sessions associated with:
- A contrast in U.S. and EU cGMP regulation and enforcement
- Effective design and monitoring of bio facilities and their utilities
- Cleaning verification and validation
- Best practices when manufacturing advanced therapy medicinal products (ATMPs)
- Developing a QC strategy for biomolecular characterization
- How to audit bioprocessing facilities, manage risk and investigation of common process deviations
Want more? We have three hours of additional self-paced material that covers:
- Specific issues for cold chain management of biomolecules
- Common concerns when formulating and filling bio drug products
- Microbial contamination control during bioprocessing
- Key steps in contracting out processes; and minimizing the risk of drug shortages and batch rejection
Course delivery details
If you choose our virtual learning option, 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.
All of NSF's pharmaceutical training courses can be brought on-site, tailored to your key concerns and delivered at a time that suits you.
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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Reviews
Average rating 5
Good overview. Very good speakers. Thank you!
Expenses
Discounts
Multiple participant and early bird booking discounts available. Discounts also offered to NHS staff, regulators and charities.
Excellent overview of production of biotech products!