GMP Training (GMP02)
This one day course is updated regularly to provide clients with current GMP trends and information. This course is designed for all people who work in a GMP regulated environment.
For example;
- All Quality Assurance personnel
- All Quality Control personnel
- Middle Management in Operational and Manufacturing personnel
- Technical Specialists new to the GxP regulated industries
- Validation personnel
As the FDA states; “Training in current Good Manufacturing Practise shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.” – 21 CFR 211.24 (a)
Learning Objectives and Course Description
This course includes:
- understanding the intricacies of GMP
- having a knowledge of the worldwide regulatory landscape and the application and implementation thereof and recent GMP trends
- Quality Management, the relationship between Quality Assurance, Quality Control, the GMP codes and Quality Management Systems
- documentation error minimisation, the GMP requirements for Documentation systems
- team responsibilities in a GMP context
- a hierarchical Documentation system and how to make the system effective and compliant
- developing an internal audit plan and internal audit requirements
- effective responses to internal and external audits
- GMP requirements for customer complaint handling systems
- GMP requirements for product recall systems
- have a thorough and complete understanding of GMP and the intent of GMPs worldwide
- understand how the PIC/S cGMP impacts upon their GMP regulated environment
- have a knowledge of the worldwide regulatory landscape and the application and implementation thereof
This one day course is intended to provide participants with a working knowledge (illustrated by recent examples) and understanding of the current cGMP.
Benefits include
- learning from experienced professional trainers
- understanding GMP and its applications for quality assurance professionals
- one on one tuition during the course as the classes and are small and intimate
- receipt of a complete training kit, trainer’s notes and a certificate of completion for participants assessed.
View schedule and how to make a booking.
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