Level
Introductory
Format
On-site, practical, including essential theory
Duration
5 days
Cost
$4,389
Overview
This course equips new employees with the foundational knowledge and practical skills needed to work confidently in a biopharmaceutical manufacturing facility. It blends hands-on training with essential theoretical instruction, covering Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), gowning, aseptic techniques, and the operation of common manufacturing instruments and equipment.
Participants gain hands-on experience with tools such as pH and conductivity meters and practice working in a laminar flow hood, ensuring they develop the core competencies required to succeed in a biomanufacturing environment.
Why It’s Essential
Biopharmaceutical manufacturing demands precision, regulatory compliance, and a clear understanding of controlled environments—requirements that can be challenging for new employees without structured, practical preparation. This course provides a safe, guided introduction to these expectations, enabling participants to build confidence before entering an operational facility. By developing core competencies early—including documentation accuracy, equipment handling, proper gowning, and aseptic technique—they reduce onboarding time, minimize errors, and contribute more effectively from day one.
Learning Objectives
Upon successful completion of this course, participants will understand:
- Good Manufacturing Practices (GMPs) and how they impact everyday work
- How to document in a controlled workplace including deviation and incident reporting
- How to use, maintain, and calibrate general equipment
- How to gown for controlled areas (Class D and Class C)
- How to navigate in a manufacturing facility (including material and personnel flow)
- How to work aseptically in laminar flow hoods and the concept of bioburden control
Who Should Attend
- Newly hired operators and technical staff, as a part of onboarding in a modern biopharmaceutical or bioprocessing facility
- Anyone in a manufacturing support role including QA auditor and production support technicians
Participants who successfully complete a theoretical assessment will receive a certificate of completion.
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