Continuing Education

Through NCTM, current pharmaceutical industry professionals can learn new skills to continue to meet the demands of this rapidly-changing field.  Each of NCTM’s continuing education courses is developed and delivered by industry-experienced instructors and academic experts.  Our curriculum incorporates principles of engineering and science in a variety of focus areas, including bioprocess equipment operations; process development, optimization, and scale-up; monitoring, analysis and testing; GLP, GMP, and much more.

Cell Culture Techniques

This 3-day hands-on continuing education course provides an overview of growth, maintenance, and preservation of the major industrial organisms for making protein products. The course includes hands on modules designed to train attendees through extensive practical exercises on aseptic technique and good manufacturing practices.  Participants will understand the differences in cell growth requirements from each industrial platform, familiarize with the cultivation techniques and critical control parameters. Case studies accompany the lecture where attendees can monitor metabolites, check cultures for contamination, and build up a cell bank. Upon completion of the course, participants will gain real-world experience in the cell culture laboratory including equipment, monitoring, and safety procedures.  

    • Day 1: Safety overview, overview of cell culture in the pharmaceutical industry, choosing a cell line, cultivating mammalian cells, aseptic technique, thawing and recovery of mammalian cells, passaging suspension and adherent mammalian cells
    • Day 2: Making a stable cell line and cryopreservation, cell preparation and PCR-based mycoplasma detection (reaction), analysis of cell metabolism and product formation, agarose gel electrophoresis, analysis of mycoplasma detection results, cryopreservation of suspension mammalian cells
    • Day 3: Using HPLC to detect product formation, analysis and discussion of HPLC results, overview of rocker bag system and controller, inoculation of a rocker bag bioreactor

Bioreactors & Upstream Bioprocessing

This 4-day hands-on continuing education course provides an understanding of the key principles of upstream bioprocessing. Topics such as common expression platforms for biopharmaceutical production; bioreactor configurations and processes; media composition and formulation; and critical control parameters for bioreactors will be covered in the course. Hands-on lab activities will also be presented, which follow an upstream bioprocess and will provide opportunities for the practical application of the course materials. Multiple case studies, based on upstream bioprocess that are used in industry settings, will also be featured and provide a comprehensive look at the information covered and guided discussions.   

    • Day 1: Introduction to upstream processing, upstream bioprocesses and bioproducts, cell culture platforms and media, critical control parameters, bioreactor configuration and processes, inoculating a bioreactor
    • Day 2: Harvest, clarification, and storage of biomass, discuss analytes, review critical control parameters and effects on biomass
    • Day 3: Process analysis, SDS-PAGE, HPLC, metabolite analysis, growth curve construction
    • Day 4: Comprehensive case study comparing/contrasting different expression platforms: CHO cells stirred tank, E. Coli stirred tank, insect cells

Bioseparations & Downstream Processing

This 3-day hands-on continuing education course is designed to cover common principles and applications of biomolecule separations used in the manufacturing of therapeutics. In this course, participants will be exposed to the theory, operating principles, scale-up considerations and obtain hands on experience of common downstream unit operations to better understand how they can be used together to form a robust and efficient process.  Course topics include a survey of downstream bioprocesses and bio products, recovery of intracellular biomolecules, centrifugation separations, normal flow filtration, filter integrity testing, membrane separations utilizing TFF, column chromatography separations and calculations for each unit operation to aid in the scale-up and product recovery. 

    • Day 1: Introduction to downstream processing, downstream bioprocesses and bioproducts, cell lysis homogenization with CFU plates/microscopes, centrifugation operations, calculations, and applications in bioseparations, centrifugation demo and calculations using tubular bowl
    • Day 2: Normal flow filtration and uses in bioprocessing, depth filtration scale-up calculations and data, scalable depth filtration process and filter integrity testing, set-up/basic operations/process design for membrane separations using TFF, TFF UF/DF separation using optimized parameters, results with calculations
    • Day 3: Principles and modes of chromatography (IEX, HIC, Affinity, SEC, RPC), dynamics of packed bed chromatography and other configurations, using different resins, flow rates, pH, column chromatography scale-up calculations and use of AKTA pilot and column, mass balance, recovery and analytics

Vaccinology 101

A 2-day continuing education course that reviews the biological basis of vaccination as a strategy to control infectious diseases. The course addresses the molecular basis of pathogenesis; with emphasis placed on virus structure/function relationships; host cell interactions; recovery from disease; the immune system and how vaccines work to create immunity; and the essential features of the host-pathogen interaction. Specific examples of important bacterial and viral pathogens along with select agents will be covered and case studies will be provided to promote discussion.

    • Day 1: Viral agents, bacterial agents, epidemiology, biothreats, immune system, antigen processing/presentation, T Cells, B Cells and antibodies, techniques for cultivation and quantitation of microbes, examine history, present state, and future of vaccine development
    • Day 2:  Immunological memory and vaccine effectiveness, anti-microbial resistance, conjugate vaccines, vaccine delivery, adjuvants

Regulatory Compliance in the Pharmaceutical Industry

This 2-day continuing education course targets research, medical, and biotechnology professionals who require an understanding of the Food & Drug Administration (FDA) and regulatory compliance. Includes FDA background: history, major laws and regulations, and guidance regulations; Working with the FDA: types of regulatory submissions, meetings with FDA and preparations, and inspections and enforcement; Complying with FDA Regulations: GxPs and their related regulatory framework, documentation, vendor qualifications, internal quality audits, change control; International Regulatory Environment: conference on Harmonization, major regulatory agencies, organization for standardization.

    • Day 1: FDA background, major laws/regulations, guidance vs. regulation, organizational structure, types of submissions, drug development cycle
    • Day 2: Meetings and preparation, FDA inspections, FDA enforcement, GLP/GMP/GCP, documentation, supplier qualification, internal quality audits, quality policy and management, change control, ICH/other agencies/ISO/regulation of foreign trade

Corrective and Preventative Actions (CAPA)

This 2-day continuing education course provides an in-depth examination of effective root cause analysis and failure investigation, deviation management and documentation, corrective actions, and other elements of risk mitigation. The course explains the regulatory environment surrounding CAPA, how the CAPA system works, the basics of an investigation, and how an investigation is performed. Case studies, exercises and group activities allow participants to gain knowledge from the instructor, as well as peers.

    • Day 1: Understanding CAPAs, regulatory expectations, deviations, out of specifications, investigation initiation
    • Day 2: Investigation skills, effective CAPA SOP, CAPA tools, quality data analysis, fishbone diagram, is-is not analysis, root cause analysis, risk management, CAPA challenges

Pharmaceutical Supply Chains

This 2-day continuing education course presents how supply chain concepts can be used to improve the product quality and reduce consumer risks throughout the life-cycle of a pharmaceutical product while maintaining sustainable business performance. Emphasis will be given to the manufacturing of API’s, registered intermediates and critical raw materials. Fundamental supply chain concepts will be presented in the context of the pharmaceutical regulatory environment; topics include supply chain fundamental concepts, inventory management, supplier relationship management, cold logistics systems, and supply chain integration concepts. Class instruction will be complemented with case studies, interactive simulators, and team exercises that will provide opportunities to practice these concepts.

    • Day 1: Introduce the fundamentals of supply chains in the context of the pharmaceutical industry and its regulatory environment; Provide an understanding of inventory management concepts and methods for delicate and regulated materials; Present a framework for supplier selection, qualification, security assessment, and evaluation and continuous monitoring
    • Day 2: Describe logistics concepts with an emphasis on the transportation, storage and handling concepts of delicate, temperature controlled products; Introduce integration concepts and related benefits to the pharmaceutical supply chain

Human Error & Resilience in Biomanufacturing Systems

This 2-day continuing education course examines how human error impacts the safety and quality of operations in biomanufacturing processes.  Reason’s error classification model and the Skill-Rule-Knowledge behavioral modes are reviewed in order to highlight how individual breakdowns may lead to error within a system.  Case studies are presented to illustrate how environmental and human factors, such as workload, stress, and time pressure interact to significantly affect the outcome of processes.  Discussion of strategies including error prediction and analysis, operator practices and training, and system design is included to explore how Biomanufacturing systems can be built safer and more resilient. 

    • Day 1: Systems engineering fundamentals, humans and sociotechnical systems, cognitive human factors, human-technology interaction
    • Day 2: Introduction to human error and error management, Rasmussen's skill-rule-knowledge framework, Reason's human error classifications, error prediction and analysis techniques, system design strategies for error management, fundamentals of resilience and systems safety, lessons from high reliability organizations