GMP for Biological and Biotechnology Products Training
About This Course
This course details the rules and interpretation of GMP for biopharma products and discusses issues and challenges with seasoned NSF experts.
The course provides insights on how to interpret and deploy the requirements of both the US cGMP and EudraLex Volume 4 (particularly Annex 2). It covers the cGMP requirements for each key process step especially concerning process development, validation, control, auditing, effective quality assurance (QA) and quality control (QC).
This course is offered virtually and the 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.
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
- 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 US 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 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
Robert Smith - Robert has more than 30 years’ experience in the pharmaceutical industry, in various production and quality roles for a number of major international pharmaceutical organizations. He is eligible to act as a Qualified Person under the permanent provisions for both commercial and investigational medicinal products. He is a QP assessor and Vice Chair of the Royal Pharmaceutical Society Panel of Assessors. Robert has broad experience in QA and manufacturing management gained through working with a wide range of dosage forms for both commercial and clinical supply, including solids, liquids, sterile products, vaccines, biological, biotechnology, viral vectors, gene therapy and cellular therapy products.
Nick Martin – Nick has 20 years of experience of biologics manufacturing within a CDMO, encompassing clinical and commercial production, in both stainless steel and single use equipment within multi-product facilities. He has worked on products throughout their lifecycle in a variety of manufacturing, engineering and leadership roles. Nick is a Visiting Senior Lecturer at King’s College London and a Fellow of the Institution of Chemical Engineers. He brings expert applied knowledge of the design, start-up, operation and regulation of manufacturing facilities at large scale for biotechnology products.
Discounts
Multi-delegate discounts available. Discounts also offered to NHS staff and charities.
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You can view our booking terms and conditions from here.
Multiple Delegate Discounts are available for delegates from the same company attending the same course.
The first delegate must pay full price. The second delegate will receive a 20% discount. The third and any subsequent delegates will receive a 50% discount. Charities and NHS staff are entitled to a 50% discount. (Proof will be required).