Introduction to Biopharmaceutical Manufacturing: GMP & Biotech Bootcamp for Graduates

Take the next step in pharmaceutical training with Biotech Training Facility. Our fully equipped labs, cleanrooms and state-of-the-art utilities create a real-life production environment perfect for hands-on experience.

Duration
2 days
Course fee
€ 250 (excl. VAT)

Short description

During this course you will get acquainted with GMP at a theoretical and practical level.

Immerse yourself in the world of GMP through our comprehensive e-Learning modules. Dive deep into 9 engaging modules covering crucial topics, from GMP essentials to quality standards. Gain in-depth knowledge and expertise at your own pace. you will have the opportunity to ask all of your questions to our GMP & Biotech experts.

Get a firsthand overview of the common production processes: USP and DSP. Explore the world of cleanrooms and gowning, and experience a production floor during an exclusive tour. Sharpen your skills as you practice aseptic handling in a LAF hood. Take samples from a fermentor and master the art of working with batch records and SOPs. Plus, get hands-on experience on the filling line, putting theory into practice while learning aspects of environmental monitoring.

Objectives

Through eLearning, practical lessons and guided tours you will get a complete picture of and a good insight into the topics below:

Introduction to GMP: You will first become acquainted with the principles of Good Manufacturing Practice (GMP). This knowledge will be put into practice in order to gain a good insight into the role and importance of GMP.

Contamination control: A GMP production takes place in a controlled environment aimed at preventing contamination of the product. Production personnel work in cleanrooms and wear protective clothing. There are many kinds of measures with regard to the design of production areas, the use of materials and staff behavior.

Manufacturing: You will learn about and experience the different phases in biopharmaceutical production, including fermentation, chromatography and aseptic techniques. With practical assignments you gain experience in a real-life production environment.

Target group

This course is suitable for Graduates of Life Sciences, with no experience in GMP or biopharmaceutical manufacturing industry.

Program

eLearning

 

eLearning Part 1

- Introduction to GMP
- Quality Systems
- Deviations and Out of Specifications (OOS)
- Pharmaceutical Documentation
- Change Control

 

eLearning Part 2

- Training of Employees
- Equipment, Facility and Production
- Raw Data and Data Integrity
- Contamination Control

Practical day

09:00

Welcome & Introduction

 

Tour through the facility

 

Working according to SOPs and Batch Records

 

Working with the Filling line

 

Aseptic handling

17:00

Evaluation & Close Out

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Interested in signing up a group of people for this course?

Please contact our Business Development team:
info@biotechtrainingfacility.nl
+31 (0)88 2830100

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Know how.
Know why.

Need help? Have a question or a suggestion maybe?

Drop us a line below or call us on
+31 (0) 88 283 01 00.

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