Category :

Fundamentals

CASTL’s Fundamentals curriculum offers introductory courses that develop core technical skills for laboratory and manufacturing settings, including equipment, facilities, essential practices, and contamination control.

Foundations of Biopharma Processing

Virtual

Duration Half-day
Fee $420

Biopharmaceuticals are among the most complex products in modern medicine, and their manufacturing processes are equally sophisticated. This course offers a clear, comprehensive overview of the biopharmaceutical manufacturing journey, from vial to vial. Through a combination of expert-led presentations and virtual facility tours, participants gain insight into real-world manufacturing environments, understanding how each stage connects to ensure product quality, safety, and regulatory compliance.

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Foundations of Biopharma Processing

On-site

Duration 1 day
Fee $836

Biopharmaceuticals are among the most complex products in modern medicine, and their manufacturing processes are equally sophisticated. This course offers a clear, comprehensive overview of the biopharmaceutical manufacturing journey, from vial to vial. Through a combination of expert-led presentations and virtual facility tours, participants gain insight into real-world manufacturing environments, understanding how each stage connects to ensure product quality, safety, and regulatory compliance.

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Biopharmaceutical Manufacturing Boot Camp

On-site

Duration 5 days
Fee $4,389

This course equips new employees with the foundational knowledge and practical skills needed to work confidently in a biopharmaceutical manufacturing facility. It blends hands-on training with essential theoretical instruction, covering Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), gowning, aseptic techniques, and the operation of common manufacturing instruments and equipment. Participants gain hands-on experience with tools such as pH and conductivity meters and practice working in a laminar flow hood, ensuring they develop the core competencies required to succeed in a biomanufacturing environment.

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Introduction to Single-Use Technologies

On-site

Duration 2 days
Fee $1,881

Single-use technology is now widely adopted across the biopharmaceutical industry and has become a core element of modern operations. This course introduces the key single-use systems used in both upstream and downstream processing and provides hands-on experience with common disposable technologies, including bioreactors, aseptic connection, and disconnection methods, tube welding, and single-use systems applied in downstream workflows. Participants also explore strategies for implementing single-use components effectively, along with the regulatory considerations and risk-management approaches related to leachables and extractables studies.

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STERIS Master Class: Applied Cleaning Validation

On-site

Duration 2 days
Fee $1,881

This intensive course, presented by industry experts, covers industry best practices, regulatory expectations, and trends in cleaning and cleaning validation. It is designed for biopharmaceutical manufacturers seeking to develop or maintain a high-quality, efficient, and compliant cleaning process. Through a mix of expert instruction, real-world case studies, and hands-on exercises, participants tackle current challenges and gain practical skills they can apply immediately.

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Cleanroom Cleaning Workshop

On-site

Duration Half-day
Fee $543

Single-use technology is now widely adopted across the biopharmaceutical industry and has become a core element of modern operations. This course introduces the key single-use systems used in both upstream and downstream processing and provides hands-on experience with common disposable technologies, including bioreactors, aseptic connection, and disconnection methods, tube welding, and single-use systems applied in downstream workflows. Participants also explore strategies for implementing single-use components effectively, along with the regulatory considerations and risk-management approaches related to leachables and extractables studies.

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Essential Lab Skills: Balances, Conductivity, pH and Pipetting

On-site

Duration 1 day
Fee $836

In routine laboratory operations, even a single gram weighed incorrectly or a microlitre dispensed inaccurately can introduce errors that later surface as audit findings. To prevent and address such issues, this course emphasizes Good Documentation Practices (GDP) and essential laboratory skills, providing participants with a strong foundation in lab operations and the confidence needed to avoid costly batch or process deviations. It also introduces best practices in pipetting and the use of volumetric measurements in general laboratory work. 

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Contamination Control Workshop

On-site

Duration 1 day
Fee $998

This course is designed to address the growing regulatory focus on robust contamination control strategies. Participants develop a strong understanding of why contamination control is essential and how to implement it effectively in daily operations. Core topics include contamination sources and prevention methods, cleanroom classification and workflow, gowning procedures, environmental monitoring, aseptic technique in biosafety cabinets (BSCs), and best practices for cleanroom cleaning and maintenance.

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Best Practices: Aseptic Solution Handling and Transfer

On-site

Duration 2 days
Fee $1,881

Biomanufacturing requires the production of both excipients and final products in liquid form. Managing solutions at industrial scale—whether in pilot or commercial operations—demands well-planned, quality-driven practices to maintain sterility throughout the process and mitigate contamination risks. This course offers a solid foundational understanding of cleanroom classifications, contamination control strategies, and sterilization methods essential for aseptic liquid handling and transfer.

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Equipment Qualification

On-site

Duration 1 day
Fee $1,045

This course equips participants to perform equipment qualification effectively in regulated (GxP) environments. Covering the full qualification lifecycle—along with the execution and documentation of protocols for biological safety cabinets (BSCs)—it provides the skills needed to maintain compliance, prevent costly errors, and protect product quality and patient safety. Participants gain practical, hands-on knowledge in Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), the core elements of equipment compliance across the pharmaceutical, biotech, and cosmetics sectors.

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Biopharma Nanotraining

On-site

Duration 2-3 hours
Fee Contact us

CASTL delivers interactive nanotrainings (short, highly focused learning modules designed to build a specific skill or understanding in a concise, efficient format) using state-of-the-art equipment at our GMP-simulated training facilities in Charlottetown, Montreal, and Vancouver. These sessions feature practical, hands-on components and are structured to introduce participants to the operating environment, core systems, key equipment, and fundamental unit operations found in modern biopharma manufacturing facilities.

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Laboratory Best Practices: Pipetting Techniques

On-site

Duration 1 day
Fee $1,045

This practical one-day workshop focuses on best laboratory practices, with an emphasis on pipetting techniques for both new and experienced personnel. It ensures participants develop and apply proper methods that consistently deliver accurate and precise results.

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Biopharma Manufacturing

CASTL’s Biopharma Manufacturing curriculum delivers hands-on training across the full production process for modalities such as recombinant proteins, mRNA-LNP therapies, and cell and gene therapies.

Upstream Essentials: Cell Culture and Bioreactor Operations (Theory and Practical)

Virtual / On-site

Duration 2.5 days
Fee $2,406

Upstream operations form the foundation of successful biopharmaceutical manufacturing. These processes include multiple time-intensive steps where rigorous contamination control is essential to protecting product quality and consistency. Preventing contamination during open aseptic handling of cell cultures, as well as within closed systems, is critical to sustaining high manufacturing success rates. Bioreactors, with their complex components, play a central role in maintaining optimal conditions for living cells, enabling high productivity and consistent product quality.

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Downstream Essentials: From Cell Harvest to Final Purification (Theory and Practical)

Virtual / On-site

Duration 2.5 days
Fee $2,406

This course introduces participants to the key downstream operations in biopharmaceutical production. It combines lecture-based theory with hands-on practical training covering core topics such as harvest, ultrafiltration/diafiltration, viral clearance, and chromatography.

Participants first learn the fundamentals of filtration and chromatography in a classroom setting, then apply this knowledge during guided practical sessions that replicate real-world manufacturing processes.

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Introduction to Fill-Finish

On-site

Duration 2 days
Fee $1,881

This course offers a comprehensive introduction to aseptic techniques used in modern filling environments. Participants learn the principles of contamination control, environmental monitoring, filter integrity testing, and filling system operation. The program also includes hands-on interaction with RABS or isolator units, providing practical experience in performing glove integrity tests, conducting media fills, and troubleshooting common issues encountered in aseptic processing.

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Introduction to mRNA/mRNA-LNP Biomanufacturing

On-site

Duration 3 days
Fee $2,717

RNA-based biopharmaceuticals are transforming modern medicine. Among them, messenger RNA (mRNA) therapies encapsulated in lipid nanoparticles (LNPs) have emerged as commercial frontrunners, paving the way for a new generation of preventive and therapeutic applications. In response to growing industry demand and the need for skilled professionals, this hands-on introductory course, developed in collaboration with academic and industry experts, strengthens core competencies in mRNA production and LNP formulation by combining essential theoretical knowledge with practical, applied training.

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Introduction to Cell Therapy Manufacturing in GMP

On-site

Duration Half-day
Fee $679

Cell therapies are reshaping the treatment landscape for diseases once considered untreatable, including several forms of cancer. CAR-T therapies, in particular, have progressed from labour-intensive, manual aseptic processes to increasingly automated and closed manufacturing platforms.

To support this evolving field, CASTL has developed this introductory course focused on cell therapy biomanufacturing. The program provides hands-on experience with the CliniMACS Prodigy system, covering component identification, process flow, tube-set installation, and operation of an end-to-end integrated cell manufacturing platform used in the production of CAR-T, CAR-NK, and stem-cell-based therapies.

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Introduction to Fill-Finish Using Isolator Technology

On-site

Duration 2 days
Fee $1,881

This course provides an introductory overview of aseptic processing using isolator technology. Offered as a blend of theoretical content and practical modules on isolator systems, it is based on CASTL’s Introduction to Fill-Finish course and focuses on the use of isolator technology.

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Regulatory and GMP

CASTL’s Regulatory and GMP curriculum strengthens the skills and mindset needed to work in regulated pharmaceutical environments, using real-world scenarios to reinforce GMP principles and the focus on delivering safe, high-quality products.

Good Manufacturing Practices (GMP) in Biopharmaceutical Manufacturing

Virtual

Duration Half-day
Fee $543

Good Manufacturing Practices (GMP) are essential when producing complex biopharmaceutical products, which require advanced contamination control strategies to ensure product quality and patient safety. These requirements affect everyone involved in the manufacturing process, whether directly or indirectly. This course offers a high-level overview of the full biopharmaceutical manufacturing workflow—from vial to vial—while connecting each process step to the regulatory expectations and operational context of GMP.

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Deviation Handling and GMP Investigations

On-site

Duration Half-day
Fee $543

When deviations arise, the strength of your investigation process directly influences product safety, regulatory compliance, and your organization’s credibility. This course provides participants with the mindset, methodologies, and practical tools needed to handle GMP deviations as regulators expect—using a structured, compliant approach that prioritizes accurate root cause identification. Through a realistic, scenario-based approach, participants are immersed in a simulated deviation case, working collaboratively to analyze root causes and apply tools such as the 5 Whys and Ishikawa (Fishbone) diagrams. The training fosters critical thinking, cross-functional collaboration, and practical application of GMP principles. 

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Risk Assessment in GMP Environments

On-site

Duration Half-day
Fee $543

Regulatory authorities expect organizations to integrate risk management throughout all aspects of GMP operations. This course equips participants with the tools and mindset needed to proactively identify, assess, and mitigate quality risks. Through an engaging, interactive workshop, participants learn how to conduct effective risk assessments, with a particular focus on environmental monitoring (EM) and alignment with ICH Q9 and EU GMP Annex 1 expectations. Using tools like the Risk Matrix and Failure Mode and Effects Analysis (FMEA), they gain practical skills that can be applied immediately to improve decision making and reduce compliance vulnerabilities.

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GMP Readiness Accelerator

On-site

Duration 1 day
Fee $836

This course strengthens and refreshes participants’ Good Manufacturing Practices (GMP) mindset. New hires develop practical GMP skills that accelerate readiness, shorten onboarding time, and improve day-to-day performance. Through interactive discussions and real-world examples, participants gain a clear understanding of how GMP principles work together to ensure product quality, operational consistency, and regulatory compliance.

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PSG-CASTL Biomanufacturing Regulatory Compliance Course

On-site

Duration 2 days
Fee $1,881

This intensive, two-day, in-person course, co-delivered with the Pharmaceutical Sciences Group (PSG), participant with the knowledge and confidence to navigate regulated biopharmaceutical environments. Through an exploration of GMP principles and the full product lifecycle—from early development to commercialization—participants gain the skills needed to ensure product quality, safeguard patient safety, and address critical quality and validation challenges.

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Quality Control

CASTL’s Quality Control curriculum provides training in pharmaceutical product testing, including QC microbiology and QC analytics.

Introduction to Quality Control

On-site

Duration 2 days
Fee $1,881

This introductory course provides a foundational understanding of quality control (QC) practices in the biomanufacturing industry. Participants gain hands-on experience with key QC techniques used to ensure product safety, consistency, and regulatory compliance.

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HPLC Essentials: From Fundamentals to Method Validation

On-site

Duration 2 days
Fee $1,881

High performance liquid chromatography (HPLC) is a critical analytical method for in-process analytics and quality control in biopharmaceutical manufacturing. HPLC systems are complex to set up and operate. In this immersive two-day course, participants move from theory to hands-on HPLC operation and method-validation execution. By demystifying reversed-phase (RP-HPLC), size-exclusion chromatography (SEC), and ion-exchange chromatography (IEX), while guiding participants through step-by-step validation workflows, the course equips them to deliver audit-ready data for biopharmaceutical manufacturing applications, including in-process analytics, release testing and stability programs.

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Regulatory and CMC (Chemistry, Manufacturing and Controls)

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