Online Training Courses

TRIBEC 1: Overview of Biomanufacturing is the first self-paced, online course in a series of six planned TRIBEC Core Courses. The online TRIBEC 1 course provides an in-depth overview of the biomanufacturing industry with a focus on the production and development of biopharmaceuticals. Students will learn fundamental biological principles, explore upstream and downstream manufacturing processes, review key quality and regulatory requirements, and discover diverse career pathways in the industry.

Register for the TRIBEC 1: Overview of Biomanufacturing Course

This asynchronous online course comprehensively discusses the fundamental elements associated with the development and manufacture of pharmaceutical products. Training modules discuss the categories of pharmaceutical products, phases of pharmaceutical discovery, development, approval, and varying manufacturing processes (chemical or biological). The curriculum also reviews regulatory agencies and their roles, current Good Manufacturing Practices (cGMP) and GXP, quality assurance and control, and finishes with an exploration of career paths within the pharmaceutical manufacturing industry.

Certificate received upon successful completion
Participants that successfully complete the course will receive a Texas A&M Engineering Experiment Station Completion Certificate and 0.2 Continuing Education Credits (CEU’s).

This asynchronous online course provides a pragmatic study in the scientific principles of microbiology, immunology, and basic biochemistry that create the foundation for developing and manufacturing biopharmaceutical products. Curriculum covers biological macromolecules, an intensive study of infectious and non-infectious diseases, the immune system’s structure and function, pathogenesis, and categories, uses, and development process of biotherapeutics and vaccines.

What you will learn:

• Understand the history and manufacturing process of biopharmaceuticals, FDA mandates, structure and role of biomolecules, differentiate between infectious diseases caused by pathogenic organisms, viruses and noninfectious diseases, genetic and environmental factors that influence it
• Elucidate function and cells of the immune system. Differentiate between innate and adaptive immune system, active and passive immunity and primary and secondary immune response
• Introduce and explain with examples Recombinant DNA technology, protein therapeutics, gene therapy, targeting activity, monoclonal antibodies, vaccines – types, whole vs. partial organism, DNA, effectiveness and duration of immune memory with cost of development, biosimilars

Certificate received upon successful completion
Participants that successfully complete the course will receive a Texas A&M Engineering Experiment Station Completion Certificate and 0.4 Continuing Education Credits (CEU’s).

This asynchronous online course explains the expectations of and reasoning behind proper documentation protocols mandated in current Good Manufacturing Practice (cGMP) environments, like pharmaceutical production facilities. Topics include principles of data and information entry, technical writing, recording guidelines, document control, and process documentation, including laboratory notebooks, logbooks, standard operating procedures (SOPs), and batch production records (BPRs). Participants will understand the entire documentation pathway from R&D to commercialization of product, including corporate, R&D, manufacturing and qualification/validation.

What you will learn:

• Introduce regulations in pharmaceutical industry, FDA, cGMP, cGMP requirements, Title 21 CFR, federal documents, FDA enforcement, correspondence for nonconformance, importance of documentation, GMP records, “documentation pyramid ”, regulatory pathway of drug development, stages and measurable claims
• Understand document control, legal requirements for record maintenance, features of controlled documents, systems integrity, change control, recording guidelines for entering data/ making corrections/ signaling data/ reporting deviations/ corrective and preventive actions, reporting to FDA, identifiers and samples, internal auditing, risk levels, employee documentation and training
• Learn about R&D documents/ development protocol/records/reports/procedures, log, books, SOPs- SOP development, types, writing, flowchart use. Understand use of batch records, qualification documentation/ activities, validation documentation/plan.
• Illustrate the importance of fundamental technical writing, recording original data, data collection, making entries in lab notebook, recoding laboratory procedures/inventions. Ideas, attachments, referencing and blank space.

Certificate received upon successful completion
Participants that successfully complete the course will receive a Texas A&M Engineering Experiment Station Completion Certificate and 0.4 Continuing Education Credits (CEU’s).

This asynchronous online course provides an overview of pharmaceutical manufacturing facilities, including design/layout, utilities, and equipment. Participants will study clean room design, classification, and structure, and understand the many processes that are implemented to ensure a sterile environment, including practicing aseptic technique, gowning, environmental monitoring, and sanitization. Management of chemical and biological waste, sterilization techniques, and equipment maintenance and calibration are also discussed alongside the importance of validation in a pharmaceutical facility.

What you will learn:

• Understand facility design- types of facility, design, construction, complexities, utilities design, equipment , startup procedures, and maintenance
• Illustrate clean area design – contaminants, clean room design, clean room classifications, and controlling contamination
• Learn clean area operations – aseptic techniques, human and workplace contaminants, clean room supplies and storage, and environmental monitoring
• Differentiate between sanitization and sterilization- cleaning and disinfection, types of sanitization, reasons to sterilize, sterility assurance levels, and sterilization responsibilities

Certificate received upon successful completion
Participants that successfully complete the course will receive a Texas A&M Engineering Experiment Station Completion Certificate and 0.3 Continuing Education Credits (CEU’s).

This asynchronous online course covers a wide range of safety, health and environmental (SHE) issues specifically related to the pharmaceutical industry, including environmental safety, process and product safety, biosafety levels, industrial hygiene, and physical and chemical properties. Participants will receive an overview of product development stages and vaccine production, and will learn about toxicity, toxicology, drug safety and evaluation, pharmacokinetics and toxicokinetics, as well as risk assessment and analysis. Case studies, historically significant accidents, and lessons learned are incorporated throughout to provide real-life relevancy.

What you will learn:

• Introduce concepts of Workplace safety, safety responsibilities, risks and hazards with its types, exposure and routes, local and systemic toxicity and its effects, hazardous waste and its proper handling. Interpret case studies in relation to above concepts
• Understand industrial hygiene, government regulations for pharmaceutical industries, controlling hazards, evaluation, risk assessment and industrial hygiene controls. Explain OSHA standards 29 CFR 1910 (subpart D-J / K-Z)
• Recognize risk assessment strategies and processes, evaluations of Hazardous Operations (HAZOP), analysis, evaluation and management of risks.
• Learn basics of laboratory safety, definition of biosafety and their levels, CDC lessons, standard microbiological practices, safe storage of toxic materials, lab security, BSL1-3, about clean benches and biosafety scenarios through case studies.

Certificate received upon successful completion
Participants that successfully complete the course will receive a Texas A&M Engineering Experiment Station Completion Certificate and 0.3 Continuing Education Credits (CEU’s).

This asynchronous online course provides a complete review of therapeutic products manufacturing, including small molecule (chemical) drugs and large molecule biologics.

What you will learn:

• Target site, dosage form, dose and dosage, routes of administration and classes of therapeutics
• History of small molecule therapeutics, active pharmaceutical ingredient, drug substance vs. drug product, excipients, small molecule manufacturing process, API, and final product
• Antibodies, manufacturing process, recombinant DNA technology, facilities, cell line development/host cell selection, mammalian cell lines usage, cell banking, cellular growth, biomass accumulation processes, fermentation, mammalian cell culture, harvest, product recovery, product location, trapped product release, biomass clarification, initial purification, intermediate processing steps, bulk fill/formulation and final fill
• History of vaccination, effectiveness and duration, antigen ID and categories, types (whole organism, live attenuated, inactivated whole, partial organisms, toxoid, subunit, conjugate, nucleic acid-based, DNA, recombinant vector and RNA), manufacturing process
• Cell-based therapy, gene therapy, diagnostics and treatment of infections
• FDA’s role, R&D phase, pre-clinical phase, IND application, clinical trials (phases 1-3), marketing application, other licensing applications, scale-up manufacturing, manufacturing and surveillance, getting a therapeutic to market, license period, biosimilars and additional exclusivity
• Research & development, pilot-scale run, commercial-scale run, other production activities, materials management, chain of custody, procuring materials and cold chain
• Different types of companies, Genentech case study, large manufacturing companies and characteristics, contract manufacturing organizations (CMOs), outsourced manufacturing, project management department, clinical trial materials and small/start-up pharma companies

Certificate received upon successful completion
Participants that successfully complete the course will receive a Texas A&M Engineering Experiment Station Completion Certificate and 0.3 Continuing Education Credits (CEU’s).