GMP for Biological and Biotechnology Products Training
About This Course
NSF International has made this course into a hybrid, instructor-led virtual training for 2020. Combining distance learning and instructor-led training allows you to gain insight into internationally recognized current Good Manufacturing Practice (cGMP) expectations concerning a range of bioprocesses including:
- Seed/cell banking
- Serial and bulk cultivation
- Viral inactivation
- Protein concentration
Our biotech training course discusses and interprets the cGMP requirements for each step involved with process development, validation, control, auditing, and effective quality assurance (QA) and quality control (QC).
NSF designed the course to give production, QA, QC and technical services staff detailed insight into the challenges of producing and testing biotech and biological pharma products. It allows delegates to appreciate the specific design, controls and monitoring required for ensuring bioprocesses are executed right the first time. These disciplines are explained in terms of the resources needed for each of the key bioprocesses, key equipment and utilities, and commonly required critical process parameters.
The course also introduces best practices when manufacturing advanced therapy medicinal products (ATMPs), when choosing to contract out key process steps, and specific biotech concerns when formulating the finished product. We also provide guidance on developing a QC strategy for biomolecular characterization.
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 the pharma quality system must be designed around the requirements of the biomolecule
- The course is designed to support trainee EU Qualified Persons as part of their QP application or as a valuable, highly focused continuing professional development event.
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 key 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.
The subject matter this course covers 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 current hot topics in this field in terms of 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
Key topics also include:
- Major quality challenges
- EudraLex GMP Volume 4, Annex 2
- EU and U.S. regulatory framework and expectations
- Design, control and classifications of biozones
- Cell banks and seed lots
- Starting materials, buffers and reagents
- Cultivation and harvest
- Viral contamination
- Cleaning validation
- GMP guidance
- Contracting out bioprocesses
- QC strategy and practice
- Common GMP deviations and how to prevent them from recurring
- Regulatory GMP inspection and related hot topics
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.
Multi-delegate discounts available. Discounts also offered to NSF staff, regulators and charities.
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