GMP for Biological and Biotechnology Products

NSF International, Pharmaceutical Services
Course summary
4 days
2,900 GBP excl. VAT
Next available date: 14/07/2020 08:30 - Dublin

Course description

GMP for Biological and Biotechnology Products

NSF has upgraded this course for 2019, including relocation of the course to the National Institute for Bioprocessing Research and Training (NIBRT) biotech facility in Dublin. Via interaction with our experts and plant tours, you will gain insight into the internationally recognised cGMP expectations concerning a range of bioprocesses including seed/ cell banking, serial and bulk cultivation, harvesting, centrifugation, viral inactivation, chromatography, ultrafiltration and protein concentration.

It includes discussion and interpretation of the cGMP requirements across process development, validation, control, auditing and effective QA/QC at each processing step. Following simulated processes, there will be detailed discussion to promote understanding in risk assessment, deviation investigation and batch dispositioning. This course is a unique insight into how GMP is assured across a complex process train, working alongside experts in the field.

The course is designed to allow production, quality assurance, quality control and technical services staff a detailed insight into the challenges in producing and testing biotech and biological pharma products. It will allow participants to appreciate the design, controls and monitoring required to ensure a consistent bioprocess is executed right first time. These disciplines will be explained in terms of the facilities needed for each of the key bioprocesses, the key equipment and utilities and the common critical process parameters required. The course also introduces best practices when manufacturing ATMPs, when choosing to contract out key process steps and introduces the particular biotech concerns when formulating the finished product. We have upgraded the detail presented on developing a QC strategy for biomolecular characterisation, and practical guidance on drug substance QC testing for batch dispositioning and stability testing purposes.

Through discussion groups, gemba walks and plant tours, the course will also demonstrate how to perform a GMP audit of a biotech process and facility.

Utilising guest speakers from NIBRT, and detailed interaction with the plant itself, this course is a unique introduction to this growing sector of the pharma industry.

*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.

Outcome / Qualification etc.

On completion of this course participants 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 the pharma quality system must be designed around the requirements of the biomolecule
  • Audit bioprocesses, how they are designed and controlled, what key documentation is generated and how an effective product dispositioning system is set up (considering common process deviations or cGMP deficiencies gleaned from real-life experience in the field)

The course is designed to support trainee EU Qualified Persons as part of their QP application or as valuable, highly focussed continuing professional development.

Training Course Content

The 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 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 an EU QP or QA/production/technical services professional in this field
  • Access to a biotech facility, via detailed plant tours and demonstrations; ensuring key learning objectives are met on plant


Multiple participant and early bird booking discounts available. Discounts also offered to NHS staff, regulators and charities.

About provider

pharma training courses

NSF International provides a comprehensive range of independent, third-party pharmaceutical and biotech support services covering consulting, training, auditing and regulatory guidance for the pharmaceutical industry. These services are delivered by some of the most knowledgeable experts in their fields. Our unique...

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Contact info

NSF International, Pharmaceutical Services

The Georgian House, 22/24 West End
YO62 6AF York


Sandra Grote / Beverborg, Organon, The Netherlands
Excellent overview of production of biotech products!
Martin Tribus / Sandoz Austria
Good overview. Very good speakers. Thank you!
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