Wake Tech offers short, non-degree classes and certificate programs in biotechnology. Students get hands-on experience in biomanufacturing and biopharmaceutical operations in a simulated industrial setting that follows current Good Manufacturing Practices (cGMP). This training prepares students for jobs in the biotech industry by focusing on real-world skills and industry standards.
Interested in earning a degree to work in the biotech industry? Visit Wake Tech's Biotechnologies Division.
Demonstrate knowledge and competence in the academic and technical fields related to bioprocess manufacturing
Use critical thinking to analyze and solve problems
Communicate effectively
Demonstrate positive, effective and appropriate interpersonal skills
Unit 1: Pharmaceutical Quality and CGMP - Quality methods, standards and practices utilized in the biomanufacturing industry and how the federal government regulates and enforces them.
Unit 2: Working Safely - Hazards and risks within the biomanufacturing industry and how industry practices, education and federal agencies such as OSHA work to minimize these hazards and risks
Unit 3: Measuring Process Parameters - Process variables such as length, mass, volume, pressure and other parameters are measured and converted back and forth between the metric and English unit systems
Unit 4: Chemical Processes in Biomanufacturing - Introduction to common chemicals in the workplace, basic chemical safety, nature of chemicals, chemical families, chemical reactions and mixtures/solutions
Unit 5: Equipment and Utilities - Discussion of inputs, process steps, outputs, facility organization, process equipment (tanks, piping systems, pumps, valves and seals), facility utilities (gases, water, steam, heating and cooling, hydraulics, electricity and waste treatment)
Unit 6: Controlling the Process - Common unit operations, separation methods and equipment, process control parameters and methods, process control instrumentation and manual/automatic control methods
Unit 7: Facilities and the Manufacturing Environment - Facility design and operation considerations including biopharmaceutical facility regulatory requirements, facility monitoring and maintenance and contamination control concerns/methods
Unit 8: Biomanufacturing Production - Detailed discussion of biomanufacturing steps that are common to many product types and specific production steps unique to or found in a number of special product categories
In addition to the above-mentioned unit materials contained within the BioWork textbook, instruction and discussion about job-seeking skills such as resume development, searching for jobs online, LinkedIn or other professional networking tools and interview questions is included in this course. Students are strongly encouraged and invited to attend virtual career fairs that as many as 30 industry partners attend.
150
1
Partnership for Biotechnology Workforce Training - Process Technician Examination
https://www.scantron.com/wp-content/uploads/2019/07/NCBC-Candidate-Guid…
Complying with cGMP (current Good Manufacturing Practices)
Following an SOP (Standard Operating Procedure)
Completing Batch Records
Reading an SDS (Safety Data Sheet)
An awareness of the importance of safety for the workers and product
Using the metric system and measuring process parameters
Understanding mechanical components of process operations (tanks, pumps, valves, etc.)
Reading gauges
Understanding different utility requirements (water, air, electrical, waste systems) for different parts of process operations
Reading process diagrams and understanding feedback systems
Determining manufacturing process similarities and differences for various product types
Resume writing, job interview and networking skills
Bioprocess Practices, BPM-110, and Industrial Environment, PTC-110
Students who wish to register for BioWork must possess a high school diploma or GED and must complete an online information session.
"BioWork: An Introductory Course for Process Technicians, Third Edition," Revised 2020
Lab module or virtual replacements for onsite laboratory exercises
80% attendance
Students must score an 80% on each unit exam to stay in the course. Students are allowed one retest of each unit exam to reach that 80% score.,An approved resume from N.C. BioNetwork or Biotechnology Career Navigator
N/A
Those with at least a high school diploma or GED who are unemployed, transitioning, especially from other manufacturing sectors, or starting a new career. This course can also be useful for individuals with degrees in biological sciences, chemistry, biochemistry or other fields who want to enter employment in biomanufacturing or pharmaceutical manufacturing and lack the knowledge of the products, regulations and manufacturing methods used in these industries.
Bioprocess Technician 3 or 4, Manufacturing Process Technician I, Operation Specialist
Many employers within Wake County and surrounding counties
Manufacturing process technician
Bioprocess technician
Operation specialist
| Details | Section | Date(s) | Location | Price | Seats | |
|---|---|---|---|---|---|---|
| 319043 | 01/12/26 - 05/06/26 | RTP Campus | 243.00 | 0 | ||
| 319289 | 01/12/26 - 04/07/26 | Online | 225.00 | 0 | ||
| 319147 | 01/12/26 - 04/07/26 | RTP Campus | 243.00 | 0 | ||
| 319058 | 01/12/26 - 04/16/26 | Southern Wake Campus | 243.00 | 0 | ||
| 319060 | 01/12/26 - 04/16/26 | Southern Wake Campus | 243.00 | 0 | ||
| 319057 | 01/26/26 - 03/20/26 | RTP Campus | 243.00 | 0 | ||
| 319059 | 02/02/26 - 04/29/26 | Eastern Wake Campus | 243.00 | 0 | ||
| 319347 | 02/05/26 - 05/01/26 | RTP Campus | 243.00 | 0 |
If you would like to be notified when additional sections become available, please use Wake Tech's Notify Me service.
Introduce the basic skills of micropipette operation
Provide experience with a variety of micropipettes that are commonly encountered in laboratory situations
Discuss and practice techniques used to increase pipetting performance
Provide students with a way to quantify their pipetting skills and measure gains in those skills acquired during this course
Provide an introduction to the dilution of laboratory reagents/samples and the calculations needed to make those dilutions
Introduce the topic of ergonomics as it applies to laboratory procedures and the prevention of workplace injuries
Course Introduction
1.1. Lecture: Use and function of micropippetors
1.2. Lab: Testing of initial micropipetting skill levels (Artel method)
1.3. Lecture: Discussion of factors affecting pipetting performance
1.4. Lecture: Discussion of methods to measure micropipette performance
1.5. Lecture: Guide to Dilutions
Technical Instruction
2.1. Lab: Practice micropipetting
2.2. Lecture: Tips for better pipetting
2.3. Lecture: Ergonomics and Micropipetting
2.4. Lab: Practice pipetting and Gravimetric method of measuring pipetting performance
2.5. Lab: Practice pipetting with glass, serological and digital pipettes
Assessment
3.1. Lab: Final test of pipetting performance (Artel method)
Conclusions and Final Discussion
4.1. Open floor for additional questions and feedback
6
1
None
None
No
N/A
Micropipettes, different pipettes, training handouts, different solutions, micropipette tips, beakers, test tubes, test tube racks, straws, colored water and ARTEL unit and unit supplies
N/A
95% attendance
Coefficient of variation (CV) < 1% with micropipettes in two attempts or fewer
N/A
Bioprocess technicians, lab technicians, QC lab technicians and environmental monitoring technicians
N/A
N/A
Laboratory technician
Bioprocessing technician
To be notified when this course becomes available, please use
Wake Tech's Notify Me service.
Apply technical writing tips to writing investigation problem statements, RCA and CAPA to more clearly document and better resolve nonconformities
Explain CAPA system elements and FDA expectations
Explain how risk assessment tools can be used to determine priority and significance of CAPA
List different root cause analysis tools and resources
CAPA definitions and approaches
Example CAPA forms
CAPA regulatory expectations (drugs, biologics and medical products)
Pharmaceutical quality system guidelines (ICH Q10) and product lifecycle approach
Quality Risk Management (ICH Q9) and risk assessment (RA) approaches to CAPA, including Fault Tree Analysis (FTA), Hazard Analysis and Critical Control Points (HACCP), Hazard and Operability Analysis (HAZOP) and Failure Modes Effects Analysis (FMEA)
Failure Modes, Effects and Criticality Analysis (FMECA)
Sources of CAPA
FDA inspection observations (FDA Form 483)
Technical writing tips for clarity and completeness
Investigations and problem/event statements and summaries
Records/sources of information/identification
Root cause analysis (RCA) definitions, tools and approach
CAPA implementation and resolution
6
No
None
None
No
N/A
Provided by the college
Classroom or virtual meeting technology
80% attendance
N/A
Manufacture/production operators, team leaders and supervisors, quality control personnel, quality assurance personnel, maintenance/engineering personnel, training personnel, bioprocess technicians, community college faculty
Manufacture/Production Operators, Team Leaders and Supervisors, Quality Control Personnel, Quality Assurance Personnel, Maintenance/Engineering Personnel, Bioprocess Technicians
N/A
Manufacture/production operators
Team leaders and supervisors
Quality control personnel
Quality assurance personnel
Maintenance/engineering personnel
Bioprocess technicians
To be notified when this course becomes available, please use
Wake Tech's Notify Me service.
Explain the uniqueness of our industry and culture in terms entering students can understand
Define good cleanroom habits and how to properly gown
Explain types of contamination, where each comes from and how it is controlled in the process
Explain basic protein chemistry, denaturation and why A280 is used for identifying total protein
Identify basic manufacturing flow for biomanufacturing process
Identify key manufacturing equipment, utility systems, valving and sanitary fittings
Identify key process sensors and explain what a DCS system does
Define purpose of the upstream process, identify what each operation does and how it works
Define purpose of the downstream process, identify what each operation does and how it works
Explain the importance of formulation, final packaging and labeling
Biotechnology and Protein Chemistry
a. Basics of biotechnology
b. Uniqueness of industry
c. Chemistry of proteins
The Place We Work
a. Controlling contaminants
b. Key manufacturing equipment, valves and fittings
c. Key utilities
d. Automation
Upstream Manufacturing
a. Nutrient requirement and growth
b. Rules for sterility
c. Fermenter design
d. Instrumentation and control
e. Support systems
f. Fermentation operations
Downstream Manufacturing - Part 1
a. Cell disruption
b. Solid/liquid separation
c. Ultrafiltration
Downstream Manufacturing - Part 2
a. Chromatography
Formulation and Finishing Operations
a. Final concentration
b. Formulation
c. Sterile filtration
d. Freeze drying: Lyophilization
e. Packaging and labeling
8
No
None
None
No
N/A
Provided by the college
Classroom or virtual technology
80% attendance
N/A
Bioprocess technicians, students in biotechnology degree programs, those working the in pharma industry, community college faculty
Students or individuals working in the Biopharma Industry.
N/A
Bioprocess technicians
Manufacturing operator
Gene therapy operation specialist
BTC-3600B4
BTC-3200A7
CTP-YH1
CTP-ZJ1
CTP-FR01
CTP-JI01
To be notified when this course becomes available, please use
Wake Tech's Notify Me service.
Explain the importance HPLC plays in research and quality control for pharmaceutical/biotechnological/ agricultural industry and on the various applications of HPLC
Describe the principles of chromatography, its uses and interpretation
Demonstrate a basic understanding of the design, operation and control of an Agilent HPLC system, including hands-on experience using Empower 3 software.
Identify the FDA criteria for bioanalytical methods
Explain the importance of lab controls in QC
Day 1
1.1. Course Introduction
1.2. Pre-test
1.3. Background on Sample Preparation
1.4. Principles of Chromatographic Separation
1.5. Basics of HPLC
1.6. iET HPLC Video
1.7. Importance of Lab Controls
1.8. FDA Criteria for Bio-analytical Methods
1.9. Lab Overview: Assay of Walgreens Extra Strength Pain Reliever by HPLC: Method 005
1.10. Lab 1: Instructor Demonstration of Method 005
1.11. Chromatogram Interpretation
Day 2
2.1. Lab Equipment Demonstration Videos
2.2. Overview of Waters Empower 3 Software
2.3. Lab 2: Student Hands-On Solution Preparation (optional?)
2.4. Lab 3: Student Performance of Method 005
2.5. Lab 4: Reporting Results
2.6. Final Q&A
2.7. Course Wrap-Up
2.8. Course Assessment and Survey
16
No
None
None
No
N/A
HPLC machine, lab space, text and learning supplies will be provided.
Lab that has a HPLC machine
100% attendance
N/A
Pharmaceutical, biomanufacturing, biotechnology positions for quality control, quality assurance, regulatory, engineering, laboratory, manufacturing or any other associate that needs a basic understanding of high-performance liquid chromatograph, especially quality control laboratory associates with the need to understand instrumentation related to HPLC.
Manufacturing Technician, Lab Technician, QC Analyst
N/A
Lab technician
Manufacturing technician
QC analyst
To be notified when this course becomes available, please use
Wake Tech's Notify Me service.
Learn about control strategies to use in upstream processing
Develop an understanding of the phases of cell growth, cell counting and seed train, as well as aseptic technique when performing cell culture processes
Gain a fundamental knowledge of suspension vs. adherent cell lines
Gain hands-on experience initiating a mammalian cell line using Chinese hamster ovary (CHO) suspension cells
Day 1
Lecture: Upstream Processing Overview
Lecture: Contamination Control Affecting Processes
Lab: Cleaning the BSCs
Lab: Aseptic Technique
Lecture: Cell Growth
Calculations Activity: C1V1=C2V2
Lecture: Reminder of the Importance of Contamination Control
Lecture: Production Introduction
Lab: CHO-S Suspension Cell Line Initiation
Lab: Subculture of Suspension Cells
Lab: Observing for Contamination
Day 2
Lecture: Bioreactor Design
Lab: Bioreactor Identification
Lab: Inoculating the Bioreactor
Lecture: Media Composition & Conditions
Lecture: Process Control
Lab: Check Osmolality of Sample
Lab: Metabolite Analysis
Lecture: Upstream Centrifugation Considerations
Lecture: Upstream filtration considerations
Lecture: Review Q&A
Evaluations & Certificates
16
No
None
None
No
N/A
Text provided by college
Lab and cleanroom facility
80% attendance
N/A
Bioprocess technicians, bioprocess engineers, manufacturing associates, fermentation technicians, fermentation lab analysts
Gene Therapy Operation Specialist, Manufacturing Operation Specialist
N/A
Gene therapy operation specialist
Manufacturing operation technician
Bioprocess technician
BTC-3300H6
CTP-JI01
CTP-3001PD1
CTP-IL01
BTC-3300G6
To be notified when this course becomes available, please use
Wake Tech's Notify Me service.
Demonstrate proficiency with ultra-centrifugation, tangential flow filtration and anion exchange chromatography
Develop an understanding of viral filtration, column packing, SPTFF, HETP and asymmetry
Gain hands-on experience performing filtration steps to purify the target product (protein)
Gain hands-on experience identifying components of a small-scale chromatography system and performing anion exchange chromatography separation
Day 1: Protein & Process Consideration, Process Operations
- Lecture: Proteins & Process Considerations
Process flow and phases
Proteins
- Principles
Chemistry & Functions
Types of Proteins
- Green Fluorescent Protein (GFP)
Process Considerations
Impurities
- Aseptic Technique
Lecture: Process Operations
Harvesting
Cell Disruption
Lab: Ultra-centrifugation
Lecture: Process Operations
Solid-liquid separation
Lab: Filter Integrity Test/Bubble Point Demonstration
Lab: Tangential Flow Filtration
Lecture: Purification
Lecture: Performance, Trouble Shooting, Maintenance
Lecture: Filling of Bulk Drug Substance
Lecture: Yield
Review, Q&A
Day 2: Anion Exchange Chromatography
- Lab: Anion Exchange Chromatography
- Lecture: Evaluations & Certificates
16
No
None
None
No
N/A
Text, lab supplies and equipment supplied by Wake Tech
N.C. BioNetwork Capstone Center, downstream cleanroom facility or facility equipped with downstream operations equipment
90% attendance
N/A
Bioprocess technicians, bioprocess engineers, manufacturing associates, fermentation technicians, purification technicians, purification lab analysts, chromatography associates
Bioprocess Engineer, Bioprocess Technician, Gene Therapy Operation Specialist, Manufacturing Associates, Purification Technician, Purification Lab Analyst
N/A
Bioprocess engineer
Bioprocess technician
Gene therapy operation specialist
Manufacturing associate
Purification technician
Purification lab analyst
To be notified when this course becomes available, please use
Wake Tech's Notify Me service.
The objectives of this course are to provide a thorough understanding of:
• sterilization
• sterile equipment design
• regulatory requirements associated with sterilization
• methods used to test and validate sterile processes
• controlled-temperature environments, including design
• associated regulatory requirements
Day One
Morning session:
Introduction to Steam Sterilization
Autoclave Design
Regulatory Requirements
Acceptance Criteria
Autoclave Testing/Validation
Troubleshooting
Afternoon session:
Field Autoclave Cycle Analysis
Field Autoclave Validation Techniques for Liquid and Dry Goods Loads
Use of the Kaye Validator for Autoclave Validation
Day Two
Morning session:
Steam-in-Place (SIP) Design
Regulatory Requirements
Acceptance Criteria
Autoclave Testing/Validation
Troubleshooting
Afternoon Session:
Field SIP Cycle Analysis
Field SIP Validation Techniques
Use of the Kaye Validator for SIP Validation
Day 3
Morning session:
Control Temperature Unit (CTU) Design
Regulatory Requirements
Acceptance Criteria
CTU Testing/Validation
Troubleshooting
Afternoon session:
Field CTU Cycle Analysis
Field Validation Techniques
Use of the Kaye Validator for CTU Validation
24
1
None
None
No
Some validation experience or having taken the Basic Concepts of Validation course is preferred.
All materials supplied by the Validation Academy
N/A
80% attendance
N/A
N/A
N/A
To be notified when this course becomes available, please use
Wake Tech's Notify Me service.
Define the elements of current Good Manufacturing Practices (cGMP) for biomanufacturing and pharmaceutical production
Explain how cGMP helps regulated companies comply with the law: Part 21 of the Code of Federal Regulations (21 CFR 211)
Understand the importance of current Good Documentation Practices (cGDP) for pharmaceuticals and Part 11 of the Code of Federal Regulations (electronic record keeping)
Recognize the consequences of failing to comply with cGMP
The mission of the FDA
The quality assurance role
Personnel and organization
Buildings and facilities
Equipment
Control of components, drug product containers and closures
Production and process controls
Packaging and labeling
Holding and distribution
Laboratory controls
Records and reports
Returned and salvaged drug products
Complaints and recalls
Good Documentation Practices (GDP)
Computer systems (Part 11)
Regulatory enforcement
4
No
None
None
No
N/A
Provided by college
Classroom or virtual meeting technology
100% attendance
N/A
Manufacturing technicians, team leaders and supervisors, quality control personnel, quality assurance personnel, maintenance/engineers, community college faculty, students
Manufacturing technicians, team leaders and supervisors, quality control personnel, quality assurance personnel, maintenance/engineers
https://www.ncworks.gov/vosnet/JobBanks/JobSearchCriteriaQuick.aspx?
Manufacturing technicians
Team leaders and supervisors
Quality control personnel
Maintenance/engineers
To be notified when this course becomes available, please use
Wake Tech's Notify Me service.
Attain an understanding of the importance of both internal and external audits.
Describe the relationship between FDA auditing activities and CGMP compliance through the Code of Federal Regulations (CFR) for pharmaceuticals.
Identify audit findings from real company inspections.
Explain do's and don'ts for FDA audits.
Distinguish the roles of company representatives during an audit.
Relate the importance of proper documentation to provide evidence of compliance with CGMP.
Perform an audit of a document used in the biopharma industry
4
No
None
None
No
None
Provided by the Community College
Classroom or virtual meeting technology
80% attendance
N/A
• Team Leaders and Supervisors, Regulatory Personnel, Quality Control Personnel, Quality Assurance Personnel, Manufacturing Technicians, Administrative Personnel (scribes), Maintenance/Engineers
Bioprocess Technicians, Quality Control Officer, Quality Assurance Coordinator
N/A
Bioprocess Technicians
Quality Control Officer
Quality Assurance Coordinator
To be notified when this course becomes available, please use
Wake Tech's Notify Me service.
Define validation as applicable to the manufacturing process of pharmaceuticals
Present factors that led to FDA's validation concept
Discuss the regulatory basis for the drug validation requirements
Review other regulatory/industry initiatives (EudraLex, ICH)
Explain why, what, when and how validations are performed
Review the following document: FDA Guidance for Industry, January 2011, Process Validation: General Principles and Practices
Explain the structure of a validation program (documents, risk-based approach)
Basic Concepts of Validation
a. Definition of Validation
b. Product Life Cycle
c. Why Validation is Important?
d. Scope of Validation
e. Timing of Validation
f. Regulatory Evolution of Validation
Regulatory Compliance
a. Role of the FDA
b. Good Manufacturing Practices (GMP)
c. FDA Inspections
d. FDA Enforcement
Part 1: 2011 Process Validation Guidance Document
a. Life Cycle Approach to Process Validation
b. Data Evaluation for Process Design to Production
c. 3 Stages of Validation: Process Design, Process Qualification, Continued Process Verification
d. Scientific Tools such as QbD, PAT and Risk Assessment
e. General Approach to Process Validation
f. Other ICH Initiatives and Concepts: Revalidation, Retrospective, Concurrent, Prospective
Process Analytical Technologies (PAT)
a. Definition of PAT
b. List of PAT Tools
c. Examples of PAT Applications
Equipment and Systems Qualification
a. Difference Between Equipment and Systems
b. Definitions of Qualifications and Validation
c. Define V-Model Validation Concept
i. Factory Acceptance Test (FAT)
ii. Site Acceptance Test (SAT)
iii. Installation Qualification (IQ)
iv. Operational Qualification (OQ)
v. Performance Qualification (PQ)
vi. Commissioning
d. How Many Batches Are Enough to Qualify?
Structure of a Validation Program
a. Validation Documentation
i. Validation Master Plan (VMP)
ii. Technical Reports
iii. Executive Summaries/Expert Reports
iv. Qualification Summary Reports
b. Maintaining a Validated State
c. Risk Management
d. Starting a Validation Project
8
No
None
None
No
N/A
Provided by the college
Classroom or virtual meeting space. Ability to present material electronically to include a computer or laptop and a display technology or smart board.
80% attendance
N/A
• Biomanufacturing faculty teaching for the community college system
• Employees working for a pharmaceutical company
• Biotechnology curriculum students
Bioprocess Technician, Manufacturing Technician, Quality Control Officer, Quality Assurance Officer, Manufacturing Science and Technology Officer, Validation Support Technician
N/A
Bioprocess technician
Manufacturing technician
Quality control officer
Manufacturing science and technology officer
Validation support technician
SEF-3001KG1
CTP-YH1
CTP-FR01
CTP-3001QF1
CTP-JI01
To be notified when this course becomes available, please use
Wake Tech's Notify Me service.
Learn the basics of microbiology, virology and immunology
Be exposed to various molecular biology techniques, including DNA/RNA extraction, PCR techniques, genotyping, sequencing, gel electrophoresis and more
Learn how molecular cell and gene therapy techniques can be used in applications for commercial product manufacturing
Learn the basics of the process from inception in research and development through product realization in manufacturing
Cell Biology
a. Eukaryotic vs. Prokaryotic
b. Structures and Functions
Microbiology
Virology
a. Characteristics
b. Types
4. Immunology
a. Immunotherapy
Genetics
a. DNA vs. RNA
b. Mitosis vs. Meiosis
c. Central Dogma and Its Steps
i. Video (From DNA to Protein)
d. Genes/Genotype/Phenotype
i. Human Genome Sequencing Video
ii. Variations (Sequencing.com Interactive Genome Map)
iii. Genetic Disorders
Concepts of Molecular Biology and Biotechnology
a. DNA Extraction/RNA Extraction
b. PCR
c. Genotyping vs. Sequencing
d. Gel Electrophoresis
e. Gene Expression
i. Regulation
f. Gene Editing
i. CRISPR/Cas9
g. Recombinant DNA
h. Plasmid Construction
i. Insulin Production Example
i. Cell Culture
i. Transfection
ii. Transformation
iii. Transduction
iv. Applications
j. Aseptic Technique
Cell vs. Gene Therapy
a. "Gattaca" video
b. Applications and Products
c. Types
i. Somatic
ii. Germline
iii. In Vivo
iv. Ex Vivo
d. Techniques
i. Augmentation
ii. Inhibition
iii. Suicidal
e. Delivery
i. Viral
ii. Non-Viral
f. Case Studies
Development of Drug Process
a. Discovery, Development and Launch Process
b. Comparison to Regular Biomanufacturing
FDA regulation
a. Analytical Techniques
b. Product Safety Requirements
c. Cell Characterization
Ethical Concerns
cGMP
Good Documentation Practices
4
No
None
None
No
N/A
Lab supplies and the text are provided by the program.
N/A
100% attendance
N/A
Industry personnel, biology faculty at community colleges, persons interested in a career in biotechnology or biopharmaceuticals
Bioprocess Technician, Gene Therapy Operation Specialist, Manufacturing Process Technician
N/A
Bioprocess technician
Gene therapy operation specialist
Manufacturing process technician
To be notified when this course becomes available, please use
Wake Tech's Notify Me service.
Understand basic microbiology and properties of bacteria, fungi and mycotoxins that can be harmful in biomanufacturing
Gain an understanding about the human impact on biomanufacturing operations
Learn environmental monitoring and collection methods for effective microbial identification and management of contamination
Understand the various analytical methods and identification techniques for identifying microorganisms so the sources of these contaminates may be prevented
Learn the methods for disinfection, sterilization and control of microbial contamination
Gain an understanding of the importance for aseptic technique in preventing contamination of the product and test articles
Introduction to Industrial Microbiology and Bacteria
a. Definition of Microorganisms
b. Prokaryotes and Eukaryotes
c. General Properties of Bacteria
d. Aerobic vs. Anaerobic Organisms
e. Medical and Industry Important Fungi (Mycoses, Mycotoxins)
Bacteria in Humans
a. Spore-forming Bacteria
b. Bacterial Growth Curve
Environmental Monitoring
a. Air Contaminants
b. Surface Contaminants
c. Personnel Contaminants
d. Product Contamination
e. Biofilms
f. Water Collection Demo
Quality Control Laboratory Testing
a. Collection Techniques
b. Quadrant Streak for Isolation
c. Colony Morphology, Cell Shape and Gram Stain
d. Detection vs. Quantification vs. Isolation
e. Analytical Profile Index
Identification Strategies
a. Preliminary Identification
b. Gram Stain
c. Historical Perspective on Bacterial Identification
d. Endotoxins
Contamination Control
a. Disinfection, Sterilization, Autoclaving
b. Aseptic Behaviors
Post-Test
Course Evaluations
8
No
None
None
No
N/A
Provided by instructor
N/A
80% attendance
N/A
Bioprocessing technicians, environmental monitoring officers, quality control specialists, training specialists
Biogen, Amgen, Fuji Biotechnologies
Environmental monitors
Bioprocess technician
Quality control specialist
Training specialists
To be notified when this course becomes available, please use
Wake Tech's Notify Me service.
Explain the uniqueness of our industry and culture in terms entering students can understand
Define basic cGMP principles and explain how they will incorporate into all lectures and activities. Make it both a mindset and a thread throughout.
Define ALCOA and be able to recognize documentation errors and write effective explanations for changes
Define good cleanroom habits and how to properly gown
Explain types of contamination, where each comes from and how it is controlled in the process
Explain basic protein chemistry, denaturation and why A280 is used for identifying total protein
Identify basic manufacturing flow for biomanufacturing process. Be able to explain the difference between mammalian and bacterial processes.
Identify key manufacturing equipment and demonstrate knowledge of diaphragm valve and use of sanitary fittings
Identify key process sensors and explain what a DCS system does
Define purpose of the upstream process, identify key operations and explain purpose. Explain differences between a fermenter and bioreactor. Perform an activity to grow bacteria cells with a flask culture, measure growth and record on graph.
Define purpose of the downstream process, identify and state what each operation does and how it works. Perform a chromatography run using GFP, measure and record results on a graph.
Explain the importance of formulation, final packaging and labeling. Explain differences in aseptic and terminal sterilization processes.
Incorporate best practices of teaching biotechnology into their own courses. Be able to write effective course objectives.
Introduction
GMP Overview and Data Integrity
Making Proteins and Biomanufacturing
Chemistry of Proteins
Process Flow Overview
Working in a Pharmaceutical Facility
Controlling Contaminants
Key Manufacturing Equipment
Fittings and Connections
Key Utilities
Automation
Upstream Manufacturing
Nutrient Requirement and Growth
Rules for Sterility
Fermenter Design
Instrumentation and Control
Support Systems
Fermentation Operations
Downstream Manufacturing
Cell Disruption
Solid/Liquid Separation
Centrifugation
Liquid Extraction
Purification
Ultrafiltration
Chromatography
Formulation and Finishing Operations
Formulation
Final Concentration
Sterile Filtration
Packaging and Labeling
Best Practices for Adult Learning
Lab Activities
Shaker Run with Bacteria
Main Fermenter Run with Bacteria
Anion-exchange Chromatography with GFP Protein
24
No
None
None
No
N/A
Provided
Access to computer and ability to project instructional material
80% attendance
N/A
Biomanufacturing faculty teaching for the community college system, SMEs from the industry that are receiving train-the-trainer training, senior training specialists, training specialists
Bioprocess Technician Training Specialists, Training Specialists, Senior Training Specialists, Quality Control,
N/A
Senior Training Specialists
Training Specialists
Training Supervisor
To be notified when this course becomes available, please use
Wake Tech's Notify Me service.
Define and distinguish pharmaceutical documents and records
Detail the regulatory requirements, functional purpose and typical industrial uses of each document type
Review 21 CFR 11 requirements and resultant impacts on electronic signatures and record keeping
Recognize emerging regulatory expectations for data handling and data integrity assurance
GMP documents
GMP records
Document control
Good documentation practices
21 CFR Part 211
Electronic records
Qualifying Excel spreadsheets
Data integrity
Medicines and health care products regulatory agency
4
1
None
None
No
N/A
Provided
Technology to project PowerPoint and relevant industry examples
100% attendance
N/A
Pharmaceutical production associates, production managers, quality managers, management, any employee who writes, edits or compiles documents used in manufacturing FDA-regulated products
N/A
N/A
Pharmaceutical production associates
Production managers
Quality managers
Management
To be notified when this course becomes available, please use
Wake Tech's Notify Me service.
Develop an understanding of the role aseptic processing plays in the manufacture of pharmaceuticals
Gain a basic understanding of microbiology in the context of parenteral drug manufacturing
Gain hands-on experience with cleaning and disinfection of aseptic processing areas
Develop an understanding of the principal sterilization methods for aseptic manufacturing
Gain hands-on experience in aseptic gowning
Day 1: Microbiology and Cleanrooms
a. Introductions
b. Lecture: Why Aseptic Processing?
c. Overview of cGMPs and GDPs
d. Cleanroom Designs and Controls (tour)
e. Lab: Cleaning of Aseptic Areas - Facility Cleaning and Selected Slides (lecture)
f. Lab: Cleaning the Cleanroom/BSCs
Day 2: Environmental Monitoring
a. Lecture: Microbiology Basics
b. Lecture: Environmental Monitoring
c. Lecture: Microbiology Basics
d. Labs: Environmental Monitoring (Finger Plates, Body Swabs, Contact Plates, Air Sampling for Viables, Air Sampling for Particulates)
e. Lab: Disinfectant Experiment
f. Lab: Component Preparation
Day 3: Sterile Product Equipment and Component Preparation Sterilization Section
a. Lecture: Aseptic Gowning and Cleanroom Behaviors
b. Video: Aseptic Gowning
c. Lab: Filtration in Cleanroom
d. Lab: Read Disinfectant Plates
Day 4: Lab and Lecture Review (Cleanroom Behaviors and Aseptic Technique Critique, Filtration Results, Gowning)
a. Lab: Solution Preparation Lecture
b. Lecture: Principles of Filtration
Lab: Review and Discuss Results of Microbiological Data
Q&A for AP I
Course Evaluations
Final Quiz and Course Wrap-up
24
1
None
None
No
N/A
Gowning materials, lecture materials, disinfectants, agar plates (finger plates, body swabs, contact plates), air sampler (viable and particulate sampling)
Capstone or RTP cleanroom facility
90% attendance
Minimum score of 80% on final quiz in two attempts or fewer
N/A
Biopharmaceutical technicians, biopharmaceutical supervisors, QA and QC personnel, persons desiring entry into the biotechnology field
Aseptic processing technician, bioprocess technician, gene therapy operation specialist, lab technician, QC or QA personnel
https://www.ncworks.gov/vosnet/JobBanks/JobSearchCriteriaQuick.aspx?pu=1
Bioprocess technician
Lab technician
Gene therapy operation specialist
Manufacturing associate
To be notified when this course becomes available, please use
Wake Tech's Notify Me service.
Define the elements of current Good Manufacturing Practices (CGMP) for biomanufacturing and pharmaceutical production.
Explain how CGMP helps regulated companies comply with the law: Part 21 of the Code of Federal Regulations (21 CFR 211).
Understand the importance of current Good Documentation Practices (cGDP) for pharmaceuticals and Part 11 of the Code of Federal Regulations (electronic record keeping).
Recognize the consequences of failing to comply with cGMP.
The mission of the FDA
The quality assurance role
Personnel and organization
Buildings and facilities
Equipment
Control of components, drug product containers and closures
Production and process controls
Packaging and labeling
Holding and distribution
Laboratory controls
Records and reports
Return and salvaged drug products
Complaints and recalls
Good Documentation Practices (GDP)
Computer systems (Part 11)
Regulatory enforcement
4
1
None
None
No
N/A
Provided by N.C. BioNetwork
N/A
100% attendance
N/A
Manufacturing technicians, team leaders and supervisors, quality control personnel, quality assurance personnel, maintenance/engineers
N/A
N/A
Manufacturing technicians
Team leaders and supervisors
Quality control personnel
Quality assurance personnel
Maintenance/engineers
To be notified when this course becomes available, please use
Wake Tech's Notify Me service.
Define and distinguish pharmaceutical documents and records
Detail the regulatory requirements, functional purpose, and typical industrial uses of each document type.
Review 21 CFR 11 requirements and resultant impacts on electronic signatures and record keeping.
Recognize emerging regulatory expectations for data handling and data integrity assurance.
GMP documents
GMP records
Document control
Good documentation practices
21 CFR Part 211
Electronic records
Qualifying Excel spreadsheets
Data integrity
Medicines and health care products regulatory agency
8
1
None
None
No
N/A
Instructor-provided supplies
N/A
100% attendance
N/A
Pharmaceutical production associates, production managers, quality managers, management, any employee who writes, edits or compiles documents used in manufacturing FDA-regulated products
Bioprocess cell technicians, pharmaceutical production associates, production managers, quality managers, management, any employee who writes, edits or compiles documents used in manufacturing FDA-regulated products
https://www.ncworks.gov/vosnet/JobBanks/JobSearchCriteriaQuick.aspx?pu=1
Bioprocess technician
Pharmaceutical production associates
Quality control manager
Quality assurance manager
To be notified when this course becomes available, please use
Wake Tech's Notify Me service.
Explain the regulatory and business rationale for SOPs
Identify FDA expectations
Define at least two approaches for determining what SOPs are needed
Identify factors that support SOP efficacy
Distinguish between methods of presenting SOP content
Analyze the structure and content of an SOP for adherence to the principles of effective SOP construction
Create an SOP based on the principles learned in the class
Understanding contemporaneous SOPs and meaningful SOP churn
Lecture - principles, philosophy, regulatory compliance
Examples - overview and analysis of SOP examples for effectiveness
Writing exercise - creation of an SOP (or virtual SOP for online classes) per the principles discussed in class
4
1
None
None
No
N/A
Provided with delivery of the course
Classroom with projection capability
95% attendance
N/A
Biomanufacturing, bioprocessing, pharmaceutical, medical device, cosmetics and other FDA-regulated industry sectors
Bioprocess technician, data quality control, QA specialist, risk management, process engineer
https://www.ncworks.gov/vosnet/JobBanks/JobSearchCriteriaQuick.aspx?pu=1
Data manager
QA manager
Subject-matter expert
Process engineer
Bioprocess technician
Risk assessment manager
To be notified when this course becomes available, please use
Wake Tech's Notify Me service.
Explain the need for aseptic gowning in aseptic processing and maintaining the gowning integrity
Review common gowning mistakes
Describe the different stages of aseptic gowning
Understand the appropriate procedure for sterile gloving and aseptic gowning
Review the various aseptic gowning techniques used in industry
Identify the phases for developing an aseptic gowning qualification program
Gowning terminology
Improper gowning citations
Sterile gloving
Aseptic gowning
Personnel monitoring
4
1
None
None
No
N/A
Computer and internet access for online course; gowning supplies for in-person classroom
Capstone, Western Wake Campus, RTP Campus lab space
100% attendance
Demonstrate Gowning Proficiency.
N/A
New and incumbent bio manufacturing employees
Bioprocess technician, gene therapy operation specialist, production operators, QA, QC, maintenance personnel, process engineers, FDA auditors, supervisors, manufacturing technicians
https://www.ncworks.gov/vosnet/JobBanks/JobSearchCriteriaQuick.aspx?pu=1
Bioprocess technician
Gene therapy operation specialist
Production operators
Quality assurance
Maintenance personnel
Process engineers
FDA auditors
To be notified when this course becomes available, please use
Wake Tech's Notify Me service.
Gain familiarity with aseptic manufacturing practices and the controls used to provide and maintain the necessary environment for the manufacturing of parenteral products, including process simulations. Aseptic technique will be a primary focus.
Perform aseptic process simulations within LAFs, BSCs and barrier isolators
Compare open-system to closed-system aseptic processes utilizing tube welder, aseptic connections and single-use disposable vessels
Conduct an investigation into aseptic processing issues and write a CAPA report based on observations
Day 1
a. Classroom: Aseptic Technique Review
b. Classroom: Microenvironments
c. Lab: Micropipetting/Automated Fill Line Demonstration
d. Lab: Aseptic Connections
e. Classroom: Product Release Testing
f. Lab: Particulate Release Testing/Steritest
g. Classroom: Regulatory Aspects of Aseptic Processing
Day 2
a. Classroom: Process Simulation and Media Fills
b. Lab: Media Fill Aseptic Simulation (manual)
c. Lab: Cupric Sulfate in Isolator/BSC Cell Culture Activity
Day 3
a. Classroom: Discussion of Aseptic Technique/Gowning from Day 2 Lab
b. Classroom: Biosafety Levels and Precautions
c. Classroom: Endotoxins
d. Video: Endotoxins – Charles River Laboratories
e. Lab: Endotoxins – PTS Unit
f. Classroom: Water Systems
g. Lab: Gram Stains/Serial Dilution of Media in an Isolator
Day 4
a. Classroom: Discussion of Aseptic Technique from Day 3 Lab Activities
b. Classroom and Lab: Lyophilization/DSC/Freeze-drying Microscopy
c. Classroom: History of Aseptic Processing
d. Classroom: Investigations Utilizing Fish-Bone Analysis
e. Review/Q&A
f. Evaluations
g. Final Written Test and Lab Practicum
24
1
None
None
No
N/A
Micropipettes, media, culture, faculty-prepared presentations, gram stain slides, biosafety cabinet, videos, gowning supplies, Laminar air flow hood, barrier isolators, chemical and media supplies
Capstone or RTP cleanroom facility, labs and classroom
90% attendance
Successful completion of lab practicum and final written test
N/A
Biopharmaceutical technicians, biopharmaceutical supervisors, QA and QC personnel, persons desiring entry into the biotechnology field
Bioprocess technician, manufacturing associate, QC & QA validation, lab technician, gene therapy operation specialist
https://www.ncworks.gov/vosnet/JobBanks/JobSearchCriteriaQuick.aspx?pu=1
Bioprocess technician
Manufacturing associate
QC & QA validation
Lab technician
Gene therapy operation specialist
To be notified when this course becomes available, please use
Wake Tech's Notify Me service.