ISPE Online Live Training Courses

This training course on Pharmaceutical Technology Transfer identifies criteria for successful technology transfer and provides ‘how to’ examples which can be individually tailored, depending on the type and scope of transfer.

This instructor lead course is an advanced level course on Cell and Gene Therapies C&GT and Advanced Therapy Medicinal Products (ATMP). The course provides an overview of the most common and established components that are leveraged in C&GT products (e.g. plasmids, mRNA, lipid nanoparticles, viral vectors), covering terminology, manufacturing processes and subsequent analytical characterization of the manufactured components and therapeutic products. The adeno-associated virus (AAV) and chimeric antigen receptor (CAR) T-cell platforms are presented as the two most common and established therapeutic technologies for Gene Therapy and Cell Therapy, respectively. The purpose of this course it to provide a fundamental understanding of the CMC considerations for C&GT products.

Worldwide Regulatory expectations and guidance as led by FDA and the EU have stated that all Pharmaceutical Quality Systems should apply a QRM (Quality Risk Management) approach. Through interactive workshops, this course will explain and apply the science and risk-based approach to integrated lifecycle Commissioning & Qualification by conducting verification of systems, equipment and facilities in accordance with the recently issued 2nd Edition Guide, ICH documents Q8 (R2), Q9, and Q10, current Regulatory Guidance, industry best practices, and ASTM E2500.

Through group exercises, this course on Quality by Design will delve into implementation and operation of an effective and efficient control strategy in manufacturing, which is a key element of process performance and product quality monitoring and continual improvement.

This course is focused on how to be compliant in the design, operation & qualification of critical utilities and how to prove it. It comprises four modules including interactive case studies from real experience. This helps the participants to experience live discussions on compliance topics. The content is primarily based on the new ISPE Good Practice Guide “Critical Utilities GMP Compliance”.

This course will cover the principles of design and operation of water systems used directly in pharmaceutical manufacturing and laboratory applications, including the essential concepts and principles of systems used to generate USP and non-compendial waters. These concepts include specification, design, operation, testing, and maintenance of equipment and systems for water generation.

This course will focus on aseptic processing and quality management around the most important pharmaceutical technology.

This training course in biopharmaceutical manufacturing facility design provides an overview of the concepts utilized in the development and renovation of sound designs for facilities that manufacture biopharmaceutical products.

This interactive advanced workshop uses case studies to provide practical tools and techniques to identify solutions for applying QRM principles to current challenges and provides hands-on experience with preparing for and facilitating risk assessments.

Specifically targeted to the needs of facility projects within the regulated pharmaceutical industry and demonstrates the value inherent in the use of “good practice” project management in the regulated pharmaceutical environment.