Accelerated Biological Drug Substance Manufacturing

Course description

Learn how to prepare for accelerated manufacturing of your Drug Substance. This course is designed to give Production, Quality Assurance (QA), Quality Control (QC) and technical services staff detailed insight into the challenges of producing, controlling and testing biotech and biological pharma products. It challenges the way current manufacturing is performed and allows delegates to appreciate the specific design, controls and monitoring required for ensuring bioprocesses are executed right the first time. These topics are explained in terms of the resources needed for each of the key bioprocesses, key systems and commonly required services such as outsourced services and material management.

Learning objectives

On completion of this course, delegates will know and understand:

• How to perform a gap assessment and identify single point of failures within the facility for production, testing, supplies, systems and resources
• How the pharma quality system must be designed around the requirements of the biomolecule
• How to verify the effectiveness of each bioprocess stage taking into account the process at hand using online and offline monitoring and testing
• How to challenge the way the manufacturing suite (upstream, downstream) are running today and what improvements need to be implemented in order to accelerate the manufacturing activities
• How to streamline testing both inhouse and outsourced testing
• The challenges associated with Material Management for bioprocessing in terms of continuing process control
• Accelerated Batch documentation methods for production and Quality Assurance to achieve effective release of product
• Introduction into the System Maturity Module, method to improve the systems supporting accelerated manufacturing

Our training helps delegates learn how to:

• Generate a risk-based, targeted gap analysis taking int account the key requirements in the EudraLex GMP Volume 4, Annex 2
• Feel confident in making the right decisions at the right time with the right information when faced with the common challenges or deviations associated with bioprocessing of drug substances
• The benefits and pitfalls of subcontracting key steps and QC testing in the bioprocess
• Identify how to review batch documentation including deviations and change controls associated with batch release
• 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

The course provides insights on how to interpret the requirements of both the EudraLex Volume 4 (Annex 2) and the U.S. cGMP.
It is designed for Production / Operation, QA, QC and technical services staff as well as trainee/practicing Qualified Persons, employees to broaden their knowledge in commercial manufacturing. Ideal for businesses looking into moving from development to commercial manufacturing or businesses that are looking into improving their manufacturing and release processes.

Quality Directors, Quality Assurance Managers, Quality Assurance specialists, Quality Operation team leaders, Qualified Persons, Quality Control Managers, Lab Heads, QC Scientists, Production Directors, Production Managers, Production supervisors, Production team leaders, MSAT, Supply Chain Managers, Retail Experts.

Prerequisites

Manufacturing, Quality Control, Quality Assurance work experience, working in the pharmaceutical industry either development or commercial environment.

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