GMP for Biological and Biotechnology Products Training

Currently there are no upcoming GMP for Biological and Biotechnology Products Training courses scheduled. Contact us to find out when the next course will run or if you need customized training. We can deliver this course and a broad range of other training topics at your location, off-site or virtually.

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About This Course

NSF International hosts this keystone training course on the rules and interpretation of GMP for biopharma products at the National Horizons Centre (NHC) and Teesside University’s Centre for Professional and Executive Development.

Our four-day 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 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). We cover the cGMP requirements for each key process step especially concerning process development, validation, control, auditing, effective quality assurance (QA) and quality control (QC).

Upgraded to reflect new trends and recent innovations, the course includes:

  • Facility tours and demonstrations, with up to five hours on plant. We’ll use virtual reality (VR) tools in training during key bioprocessing steps or in performing bioassays, and allow delegates to consider how this technology may transform the way we train staff in the pharma industry
  • Presentations by Dr. Muhammad Safwan Akram and Prof. Gary Montague on the engineering of cell lines, new advances in fermentation techniques, modern approaches to QC and the characterization of biomolecules, and an introduction to biosimilars and cell and gene therapy

Course Outline

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

Key Learning Objectives

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

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.

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.

Discounts

Discounts are available for multiple delegates, NHS staff, regulators and charities.