GMP mid-level: ins and outs

A practical training in Good Manufacturing Practice (GMP) aspects and quality systems.

Duration
2 days
Profession
QA, QC, Operations, Health Care Professionals and everyone working in the pharmaceutical industry
Course fee
€ 1495 (excl. VAT)

Short description

A solid GMP training is a basic requirement for working in the pharmaceutical industry. Biotech Training Facility therefore proudly presents this GMP training.

Theory and practice go hand in hand during this course, which enables the participants to put all acquired knowledge and skills immediately into practice.

This is a very efficient and practical method to learn the basics of GMP.

NEW! BIG registered medical specialists (Cluster 2) who follow this course as part of their general education will receive 12 accreditation points.

Objectives

Increased awareness and knowledge of the following topics:

  • Basic principles of GMP
  • History of GMP legislation
  • Basic elements of various quality systems in pharmaceutical companies, including Out of Specification (OOS), deviations, change control, GMP documentation, outsourcing of work and process validation
  • GMP requirements for equipment and facilities
  • Basic principles of risk analysis within the pharmaceutical industry
  • Data integrity rules
  • Basics of microbiology and contamination control
  • Performing environmental monitoring
  • Basic principles of GMP within a QC laboratory

Target group

Anyone who wants or needs to know more about GMP, such as QA, QC, and operations staff who perform GMP activities.

Program

Day 1

 

Theory

• Introduction to GMP history, legislation and basic principles
• Quality systems within the pharmaceutical industry, including
- deviations
- change control
- training
• Deviations and Out of Specifications
• GMP documentation
- basic principles
- importance of GMP documentation
• GMP facility and equipment
- qualification of facilities and equipment
- calibrations
- labelling of equipment
- preventing (cross) contamination
• Data integrity, including:
- importance of data integrity
- ALCOA principles (Attributable, Legible, Contemporaneous,
Original and Accurate)

 

Practice

• Tour of a GMP plant, including a visit to cleanrooms and facilities
• Making a buffer while GMP activities are being simulated, including:
- following a batch production record
- filling in a batch production record
- use of raw materials

Day 2

 

Theory

• QC activities
- role of QC
- documentation related to QC labs, such as specifications
- reagents
- reference standards
• Outsourcing of pharmaceutical activities
• Change control
• Risk assessment within the pharmaceutical industry
- basic principles of ICH Q9
- FMEA technique (Failure Mode Effect Analysis)
- risk ranking
• Contamination control, including
- basic principles of microbiology
- how to avoid microbial contamination of the product?

 

Practice

• Workshop: a risk assessment is performed in order to determine the risks in case of a production/material change
• Perform environmental monitoring tests

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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

Need help? Have a question or a suggestion maybe?

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

Thanks