Fast track your employee onboarding process with the Biopharmaceutical Manufacturing Onboarding Boot Camp. This course includes both hands-on practical training and theoretical knowledge covering good manufacturing practices (GMP), good documentation practices (GDP) including awareness of deviation and investigation, gowning, aseptic techniques, and how to operate the common equipment for all jobs in a manufacturing environment. Learners will gain the general knowledge needed to succeed in a career in biopharma manufacturing.
September 4-8, 2023
- Newly hired operators and technical staff as a part of onboarding in a modern biopharmaceutical or bioprocessing facility.
- Any individual working in a supporting role to manufacturing could benefit from this training, for example, QA auditors.
Theoretical Knowledge (1 day)
- Introduction to Good Manufacturing Practices
- Introduction to Good Documentation Practices
- Aseptic work and bioburden control
Practical Skills (3.5 days)
- Gowning practical
- Material and personnel flow in the manufacturing area
- How to use and calibrate a pH meter
- How to use and calibrate a conductivity meter
- How to use and calibrate balances
- Working under a laminar flow hood with good aseptic techniques
Upon successful completion of this course, trainees will:
- Understand Good Manufacturing Practices (GMPs) and be aware of how they impact everyday work
- Understand how to document in a controlled workplace including deviation and incident reporting
- Understand how to use, maintain, and calibrate general equipment
- Be able to gown for controlled areas (Class D and Class C)
- Understand how to navigate in a manufacturing facility (including the material and personnel flow)
- Be able to work aseptically in laminar flow hoods and understand the concept of bioburden control
A competency-based assessment will be undertaken at the end of the training course. This will certify proﬁciency pertaining to both theoretical knowledge and practical skills.
COURSE DELIVERY MODEL
- Onsite at CASTL Biomanufacturing Training Facility in Charlottetown
- One day in-class theoretical
- Three and a half days practical
Biopharmaceutical Manufacturing Onboarding Boot Camp