Fundamentals of Biomanufacturing

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Fundamentals of Validation for Medical Devices
Description

This course provides an overview of good manufacturing practices and describes the elements of a well-designed pharmaceutical facility. This will include quality, safety, utilities, basic equipment, automation, maintenance and processing.

Contact Hours
Level
Beginner
Audience

Biomanufacturing and support personnel

Topics
  • Quality
  • Safety
  • Utilities
  • Facilities, Equipment, Sensors, Automation
  • Maintenance
  • BioManufacturing Process
  • Upstream Process
  • Downstream Process
  • Final Operations
  • Controlling Cos
Objectives

Attendees who have completed this course should be able to:

  1. Explain the uniqueness of our industry, culture and history.
  2. Define basic current good manufacturing practices (cGMP) principles and purpose of validation.
  3. Identify ways that operator and environmental safety are controlled in a pharmaceutical facility.
  4. Define the key utilities used.
  5. Explain where types of contamination, where it comes from and how it is controlled in the process.
  6. Identify basic manufacturing equipment, process sensors and what a distributed control system does.
  7. Explain how maintenance is performed in a pharmaceutical process.
  8. Define purpose of the upstream, downstream, and final operation processes and be able to identify key operations within these processes.
  9. Identify key software used throughout the facility and how cost is controlled.
Delivery Options
Face-to-Face

Delivered in-person in a classroom or lab setting.

Live Instructor Led

Delivered online with a live instructor at a scheduled date and time.

College Options
Request this Course
Fundamentals of Validation for Medical Devices

This course provides an overview of good manufacturing practices and describes the elements of a well-designed pharmaceutical facility. This will include quality, safety, utilities, basic equipment, automation, maintenance and processing.

Level
Beginner
Audience

Biomanufacturing and support personnel

Topics
  • Quality
  • Safety
  • Utilities
  • Facilities, Equipment, Sensors, Automation
  • Maintenance
  • BioManufacturing Process
  • Upstream Process
  • Downstream Process
  • Final Operations
  • Controlling Cos
Objectives

Attendees who have completed this course should be able to:

  1. Explain the uniqueness of our industry, culture and history.
  2. Define basic current good manufacturing practices (cGMP) principles and purpose of validation.
  3. Identify ways that operator and environmental safety are controlled in a pharmaceutical facility.
  4. Define the key utilities used.
  5. Explain where types of contamination, where it comes from and how it is controlled in the process.
  6. Identify basic manufacturing equipment, process sensors and what a distributed control system does.
  7. Explain how maintenance is performed in a pharmaceutical process.
  8. Define purpose of the upstream, downstream, and final operation processes and be able to identify key operations within these processes.
  9. Identify key software used throughout the facility and how cost is controlled.
Contact Hours
Delivery Options
Face-to-Face

Delivered in-person in a classroom or lab setting.

Live Instructor Led

Delivered online with a live instructor at a scheduled date and time.

College Options
Request this Course