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.
Biotechnology Career Field Courses
BioWork: Process Technician Training
- Course ID: BTC-3200A7
- Overview
- Course Outline
- Requirements
- Intended Audience
- More Details
Course Objectives
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
Outline of Instruction
Pharmaceutical Quality and cGMP - Quality methods, standards and practices used in the biomanufacturing industry and how the federal government regulates and enforces them
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
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
Chemical Processes in Biomanufacturing - Introduction to common chemicals in the workplace, basic chemical safety, nature of chemicals, chemical families, chemical reactions and mixtures/solutions
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)
Controlling the Process - Common unit operations, separation methods and equipment, process control parameters and methods, process control instrumentation and manual/automatic control methods
Facilities and the Manufacturing Environment - Facility design and operation considerations, including biopharmaceutical facility regulatory requirements, facility monitoring and maintenance and contamination control concerns/methods
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
Career Development - Workshops and lectures pertaining to resume development, cover letter writing, LinkedIn creation, job-interview skills and the job-application process. Students are encouraged to review the student manual containing career-specific resources and attend career fairs when offered.
Contact Hours
152
CEUs
Yes
Industry Standard, State or National Certification
Certification
Certificate of completion
Website
None
Certification Learning Outcomes/Requirements
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
CE or CU Articulation
BTC-181: Basic Laboratory Techniques or BPM-110: Bioprocess Practices
Prerequisites
Students who wish to register for BioWork must possess a high school diploma or GED and must complete an online information session.
Learning Supplies Needed
"BioWork: An Introductory Course for Process Technicians, Third Edition," Revised 2020
Clinical Site/Special Facilities
Microbiology or chemistry lab
Requirements for Successful Completion
80% attendance
Students must score a minimum of 80% on each unit exam. Students are allowed one retest of each unit exam to reach an 80% score.,An approved resume
Accreditation/Special Approval Requirements
High school diploma or General Education Diploma
Intended Audience
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.
Specific Industry or Business Support Needs
Process technician
Wake County Need for Industry Positions
Many employers within Wake County and surrounding counties
Industry or Job Titles Related to Training Outcomes for Employment
Process technician
| Details | Section | Date(s) | Location | Price | Seats | |
|---|---|---|---|---|---|---|
| 334261 | 08/31/26 - 11/18/26 | Eastern Wake Campus | 243.00 | 0 | ||
| 334257 | 09/01/26 - 11/19/26 | Southern Wake Campus | 243.00 | 16 |
Course Cancelled
|
|
| 334259 | 09/01/26 - 11/19/26 | Western Wake Campus | 243.00 | 16 |
Course Cancelled
|
|
| 334249 | 09/01/26 - 11/18/26 | Microsoft Teams | 225.00 | 0 | ||
| 334260 | 09/01/26 - 11/19/26 | Eastern Wake Campus | 243.00 | 0 | ||
| 334207 | 09/14/26 - 11/18/26 | Western Wake Campus | 243.00 | 0 | ||
| 334236 | 10/12/26 - 12/10/26 | Western Wake Campus | 243.00 | 0 |
If you would like to be notified when additional sections become available, please use Wake Tech’s Notify Me service for BTC-3200A7-BioWork: Process Technician Training .
Micropipetting Techniques for Precision and Accuracy
- Course ID: LBT-3100A6
- Overview
- Course Outline
- Requirements
- Intended Audience
- More Details
Course Objectives
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
Outline of Instruction
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
Contact Hours
6
CEUs
Yes
Industry Standard, State or National Certification
Certification
None
Website
None
Certification Learning Outcomes/Requirements
CE or CU Articulation
No
Prerequisites
N/A
Learning Supplies Needed
Micropipettes, different pipettes, training handouts, different solutions, micropipette tips, beakers, test tubes, test tube racks, straws, colored water and ARTEL unit and unit supplies
Clinical Site/Special Facilities
N/A
Requirements for Successful Completion
95% attendance
Coefficient of variation (CV) < 1% with micropipettes in two attempts or fewer
Accreditation/Special Approval Requirements
N/A
Intended Audience
Bioprocess technicians, lab technicians, QC lab technicians and environmental monitoring technicians
Specific Industry or Business Support Needs
N/A
Wake County Need for Industry Positions
N/A
Industry or Job Titles Related to Training Outcomes for Employment
Laboratory technician
Bioprocessing technician
No active courses available at this time.
To be notified when this course becomes available, please use
Wake Tech’s Notify Me service
for LBT-3100A6-Micropipetting Techniques for Precision and Accuracy
.
Biomanufacturing: Overview of Operations
- Course ID: BTC-3600K6
- Overview
- Course Outline
- Requirements
- Intended Audience
- More Details
Course Objectives
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
Outline of Instruction
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
Contact Hours
8
CEUs
No
Industry Standard, State or National Certification
Certification
None
Website
None
Certification Learning Outcomes/Requirements
CE or CU Articulation
No
Prerequisites
N/A
Learning Supplies Needed
Provided by the college
Clinical Site/Special Facilities
Classroom or virtual technology
Requirements for Successful Completion
80% attendance
Accreditation/Special Approval Requirements
N/A
Intended Audience
Bioprocess technicians, students in biotechnology degree programs, those working the in pharma industry, community college faculty
Specific Industry or Business Support Needs
Students or individuals working in the Biopharma Industry.
Wake County Need for Industry Positions
N/A
Industry or Job Titles Related to Training Outcomes for Employment
Bioprocess technicians
Manufacturing operator
Gene therapy operation specialist
Related Courses
BTC-3600B4
BTC-3200A7
CTP-YH1
CTP-ZJ1
CTP-FR01
CTP-JI01
Course Contact Information
Siobhan D'Antonio
[email protected]
No active courses available at this time.
To be notified when this course becomes available, please use
Wake Tech’s Notify Me service
for BTC-3600K6-Biomanufacturing: Overview of Operations
.
Upstream Processing Mammalian Suspension Cell Culture
- Course ID: BTC-3300J6
- Overview
- Course Outline
- Requirements
- Intended Audience
- More Details
Course Objectives
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
Outline of Instruction
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
Contact Hours
16
CEUs
No
Industry Standard, State or National Certification
Certification
None
Website
None
Certification Learning Outcomes/Requirements
CE or CU Articulation
No
Prerequisites
N/A
Learning Supplies Needed
Text provided by college
Clinical Site/Special Facilities
Lab and cleanroom facility
Requirements for Successful Completion
80% attendance
Accreditation/Special Approval Requirements
N/A
Intended Audience
Bioprocess technicians, bioprocess engineers, manufacturing associates, fermentation technicians, fermentation lab analysts
Specific Industry or Business Support Needs
Gene Therapy Operation Specialist, Manufacturing Operation Specialist
Wake County Need for Industry Positions
N/A
Industry or Job Titles Related to Training Outcomes for Employment
Gene therapy operation specialist
Manufacturing operation technician
Bioprocess technician
Related Courses
BTC-3300H6
CTP-JI01
CTP-3001PD1
CTP-IL01
BTC-3300G6
Course Contact Information
Siobhan D'Antonio
[email protected]
No active courses available at this time.
To be notified when this course becomes available, please use
Wake Tech’s Notify Me service
for BTC-3300J6-Upstream Processing Mammalian Suspension Cell Culture
.
Sterilization and Controlled Temperature Environment Validation
- Course ID: SEF-3001A6
- Overview
- Course Outline
- Requirements
- Intended Audience
- More Details
Course Objectives
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
Outline of Instruction
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
Contact Hours
24
CEUs
Yes
Industry Standard, State or National Certification
Certification
None
Website
None
Certification Learning Outcomes/Requirements
CE or CU Articulation
No
Prerequisites
Some validation experience or having taken the Basic Concepts of Validation course is preferred.
Learning Supplies Needed
All materials supplied by the Validation Academy
Clinical Site/Special Facilities
N/A
Requirements for Successful Completion
80% attendance
Accreditation/Special Approval Requirements
N/A
Intended Audience
Specific Industry or Business Support Needs
N/A
Wake County Need for Industry Positions
N/A
Industry or Job Titles Related to Training Outcomes for Employment
No active courses available at this time.
To be notified when this course becomes available, please use
Wake Tech’s Notify Me service
for SEF-3001A6-Sterilization and Controlled Temperature Environment Validation
.
FDA Audit Preparation
- Course ID: BTC-3600H6
- Overview
- Course Outline
- Requirements
- Intended Audience
- More Details
Course Objectives
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
Outline of Instruction
Contact Hours
4
CEUs
No
Industry Standard, State or National Certification
Certification
None
Website
None
Certification Learning Outcomes/Requirements
CE or CU Articulation
No
Prerequisites
None
Learning Supplies Needed
Provided by the Community College
Clinical Site/Special Facilities
Classroom or virtual meeting technology
Requirements for Successful Completion
80% attendance
Accreditation/Special Approval Requirements
None
Intended Audience
• Team Leaders and Supervisors, Regulatory Personnel, Quality Control Personnel, Quality Assurance Personnel, Manufacturing Technicians, Administrative Personnel (scribes), Maintenance/Engineers
Specific Industry or Business Support Needs
Bioprocess Technicians, Quality Control Officer, Quality Assurance Coordinator
Wake County Need for Industry Positions
N/A
Industry or Job Titles Related to Training Outcomes for Employment
Bioprocess Technicians
Quality Control Officer
Quality Assurance Coordinator
No active courses available at this time.
To be notified when this course becomes available, please use
Wake Tech’s Notify Me service
for BTC-3600H6-FDA Audit Preparation
.
Cell and Gene Therapy
- Course ID: BTC-3300H6
- Overview
- Course Outline
- Requirements
- Intended Audience
- More Details
Course Objectives
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
Outline of Instruction
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
Contact Hours
4
CEUs
No
Industry Standard, State or National Certification
Certification
None
Website
None
Certification Learning Outcomes/Requirements
CE or CU Articulation
No
Prerequisites
N/A
Learning Supplies Needed
Lab supplies and the text are provided by the program.
Clinical Site/Special Facilities
N/A
Requirements for Successful Completion
100% attendance
Accreditation/Special Approval Requirements
N/A
Intended Audience
Industry personnel, biology faculty at community colleges, persons interested in a career in biotechnology or biopharmaceuticals
Specific Industry or Business Support Needs
Bioprocess Technician, Gene Therapy Operation Specialist, Manufacturing Process Technician
Wake County Need for Industry Positions
N/A
Industry or Job Titles Related to Training Outcomes for Employment
Bioprocess technician
Gene therapy operation specialist
Manufacturing process technician
Related Courses
CTP-JI01
SEF-79634
CTP-FE01
Course Contact Information
Siobhan D'Antonio
[email protected]
No active courses available at this time.
To be notified when this course becomes available, please use
Wake Tech’s Notify Me service
for BTC-3300H6-Cell and Gene Therapy
.
Microbiology Basics
- Course ID: BTC-3300G6
- Overview
- Course Outline
- Requirements
- Intended Audience
- More Details
Course Objectives
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
Outline of Instruction
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
Contact Hours
8
CEUs
No
Industry Standard, State or National Certification
Certification
None
Website
None
Certification Learning Outcomes/Requirements
CE or CU Articulation
No
Prerequisites
N/A
Learning Supplies Needed
Provided by instructor
Clinical Site/Special Facilities
N/A
Requirements for Successful Completion
80% attendance
Accreditation/Special Approval Requirements
N/A
Intended Audience
Specific Industry or Business Support Needs
Bioprocessing technicians, environmental monitoring officers, quality control specialists, training specialists
Wake County Need for Industry Positions
Biogen, Amgen, Fuji Biotechnologies
Industry or Job Titles Related to Training Outcomes for Employment
Environmental monitors
Bioprocess technician
Quality control specialist
Training specialists
Related Courses
SEF-79634
CTP-FE01
CTP-3001PZ1
Course Contact Information
Siobhan D'Antonio
[email protected]
No active courses available at this time.
To be notified when this course becomes available, please use
Wake Tech’s Notify Me service
for BTC-3300G6-Microbiology Basics
.
Fundamentals of Instruction for Biomanufacturing
- Course ID: BTC-3200A6
- Overview
- Course Outline
- Requirements
- Intended Audience
- More Details
Course Objectives
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.
Outline of Instruction
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
Contact Hours
24
CEUs
No
Industry Standard, State or National Certification
Certification
None
Website
None
Certification Learning Outcomes/Requirements
CE or CU Articulation
No
Prerequisites
N/A
Learning Supplies Needed
Provided
Clinical Site/Special Facilities
Access to computer and ability to project instructional material
Requirements for Successful Completion
80% attendance
Accreditation/Special Approval Requirements
N/A
Intended Audience
Biomanufacturing faculty teaching for the community college system, SMEs from the industry that are receiving train-the-trainer training, senior training specialists, training specialists
Specific Industry or Business Support Needs
Bioprocess Technician Training Specialists, Training Specialists, Senior Training Specialists, Quality Control,
Wake County Need for Industry Positions
N/A
Industry or Job Titles Related to Training Outcomes for Employment
Senior Training Specialists
Training Specialists
Training Supervisor
Related Courses
CTP-YH1
CTP-FR01
SEF-412CL
Course Contact Information
Siobhan D'Antonio
[email protected]
No active courses available at this time.
To be notified when this course becomes available, please use
Wake Tech’s Notify Me service
for BTC-3200A6-Fundamentals of Instruction for Biomanufacturing
.
Good Documentation Practices and Data Integrity II
- Course ID: BTC-3600F6
- Overview
- Course Outline
- Requirements
- Intended Audience
- More Details
Course Objectives
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
Outline of Instruction
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
Contact Hours
4
CEUs
Yes
Industry Standard, State or National Certification
Certification
None
Website
None
Certification Learning Outcomes/Requirements
CE or CU Articulation
No
Prerequisites
N/A
Learning Supplies Needed
Provided
Clinical Site/Special Facilities
Technology to project PowerPoint and relevant industry examples
Requirements for Successful Completion
100% attendance
Accreditation/Special Approval Requirements
N/A
Intended Audience
Pharmaceutical production associates, production managers, quality managers, management, any employee who writes, edits or compiles documents used in manufacturing FDA-regulated products
Specific Industry or Business Support Needs
N/A
Wake County Need for Industry Positions
N/A
Industry or Job Titles Related to Training Outcomes for Employment
Pharmaceutical production associates
Production managers
Quality managers
Management
No active courses available at this time.
To be notified when this course becomes available, please use
Wake Tech’s Notify Me service
for BTC-3600F6-Good Documentation Practices and Data Integrity II
.
Writing Effective SOPs
- Course ID: BTC-3600C6
- Overview
- Course Outline
- Requirements
- Intended Audience
- More Details
Course Objectives
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
Outline of Instruction
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
Contact Hours
4
CEUs
Yes
Industry Standard, State or National Certification
Certification
None
Website
None
Certification Learning Outcomes/Requirements
CE or CU Articulation
No
Prerequisites
N/A
Learning Supplies Needed
Provided with delivery of the course
Clinical Site/Special Facilities
Classroom with projection capability
Requirements for Successful Completion
95% attendance
Accreditation/Special Approval Requirements
N/A
Intended Audience
Biomanufacturing, bioprocessing, pharmaceutical, medical device, cosmetics and other FDA-regulated industry sectors
Specific Industry or Business Support Needs
Bioprocess technician, data quality control, QA specialist, risk management, process engineer
Wake County Need for Industry Positions
https://www.ncworks.gov/vosnet/JobBanks/JobSearchCriteriaQuick.aspx?pu=1
Industry or Job Titles Related to Training Outcomes for Employment
Data manager
QA manager
Subject-matter expert
Process engineer
Bioprocess technician
Risk assessment manager
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