GMP for Biological and Biotechnology Products Training

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 U.S. 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.

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 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

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

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.

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.

Ian White – Ian has broad experience of the pharmaceutical industry. Most recently he worked as an Expert GMDP Inspector for the UK competent authority, the MHRA, where he was responsible for developing and implementing technical and policy-based aspects of the Inspectorate work, to reduce risk and improve the quality of medicinal products for patients. He led deployment-based operations for the roll-out of COVID vaccines, therapeutics, and anti-viral medicines, working across both government and industry to ensure robust supply chains, develop policy and provide sound, pragmatic, quality risk-based guidance.

Multi-delegate discounts available. Discounts also offered to NHS staff and charities.