Aseptic Processing II
Scheduled
View available dates and register at the host college.
Wake Technical Community College
Starts: February 15, 2021
Delivery Format: Face-to-Face
Delivered in a classroom or lab setting.
Location: Capstone Center
Schedule
- Monday, February 15, 2021 - 8:00am to 3:00pm
- Tuesday, February 16, 2021 - 8:00am to 3:00pm
- Wednesday, February 17, 2021 - 8:00am to 3:00pm
- Thursday, February 18, 2021 - 8:00am to 3:00pm
Instructor: Tara Hamilton
Tuition: $622.00
Build on the foundation you constructed in Aseptic Processing Level I with this course, a hands-on experience in which you hone aseptic operational skills in a simulated CGMP cleanroom environment.
We supplement each laboratory activity with vibrant classroom discussion so what you learn isn’t just theory. You actually relate topic knowledge to aseptic processes and function.
The course faculty correlate instruction with regulatory guidelines governing pharmaceutical aseptic activities.
Aseptic technique is vital to maintain product integrity and customer safety. Currently, this class is only offered at our BioNetwork Capstone Center in Raleigh, NC.
Audience
This course equips any employee whose responsibilities depend on aseptic technique, including:
- Manufacturing Technicians
- Team Leaders and Supervisors
- Quality Control Personnel
- Quality Assurance Personnel
- Maintenance / Engineers – Aseptic Emphasis
- Plus Those Seeking Employment in the Pharmaceutical Industry
Topics Include
Meets six hours per day for four days and is aligned with regulatory guidelines. It covers:
- Microenvironments Used in Aseptic Manufacturing/Testing
- Isolator and BSC Laboratory Exercises
- Closed System Aseptic Connections
- Media Fill Process Simulations
- Product Release Testing
- Regulatory Aspects of Aseptic Processing
- Biosafety Levels and Precautions
- Endotoxins
- Water Systems
- Lyophilization Overview
- History of Aseptic Processing
- Deviation Investigations
Learning Objectives
- Perform aseptic process simulations within LAFs, BSCs and Barrier Isolators.
- Compare open-system to closed-system aseptic processes.
- Understand endotoxins and methods used for testing their presence in manufacturing operations.
- Define water’s role in parenteral drug manufacturing.
- Conduct an investigation into aseptic processing issues.
- Prescribe a CAPA report based on observations.
- Apply hands-on experience in media fill process simulations.
- Use hands-on experience of final product release testing.
Request this Course
Level: Intermediate
Lecture HoursLab or Activity HoursTotal
Delivery Options
Face-to-Face
Delivered in a classroom or lab setting.
College Options
Colleges that are able to offer this course.
Related Information
Video
Capstone Center in Raleigh is BioNetwork's premiere worker training facility. At Capstone,... more
Capstone Center in Raleigh is BioNetwork's premiere worker training facility. At Capstone,... more
eLearning
You’re the newest member of the Quality Assurance department at CATT - the Center for the... more
You’re the newest member of the Quality Assurance department at CATT - the Center for the... more
Video
One of the primary safeguards that life science companies use to help prevent contamination in... more
One of the primary safeguards that life science companies use to help prevent contamination in... more
Video
Angela Kimel provides a brief overview of the clinical research industry and career opportunities... more
Angela Kimel provides a brief overview of the clinical research industry and career opportunities... more
- 1 of 9
- >