GMP Good Manufacturing Practices
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1- Online Training...with international accreditation. The value of participation per person is €1,450
2-Requirement : specifying the course, number of participants
implementation date, and joint coordination.
Group contracting ... 20% Discount For Each Participant In Any Group Of Five Person Or More
Other Places To Hold The Course :
KualaLumpur.. Istanbul.. Dubai.. Cairo.. Riyadh.. Jeddah.. Abu Dhabi.. Doha.. Muscat.. Sharm El Sheikh.. Kuwait.. Tripoli.. Amman.. Beirut.. Damascus.. Tunisia.. Casablanca.. London.. Paris.. Barcelona.. Amsterdam.. Brussels
GMP Good Manufacturing Practices
Introduction :
A program specialized in good manufacturing practice that covers a complete explanation of good manufacturing practices (GMP) and its rules and guidelines in the European Union, the United States of America and some other countries around the world, then the practical application of GMP and the materials received for issuing the product, then GMP and the quality management system.
Course Objectives :
At the end of this course, the participants will be able to :
This course is aimed at people working in quality assurance, quality control and production staff who need a better understanding of Good Manufacturing Practices
The course provides in-depth information in the field of Good Manufacturing Practices.
During the course, the main GMP requirements for purchasing, merchandise, warehousing, production, packaging, quality control and batch issuing are covered.
In addition, the course also covers the key elements of a quality management system including documentation and training requirements and system monitoring and review.
The course includes some exercises and interactive workshops
Targeted Audience :
- For individuals wishing to work as production managers in the future
- Individuals who work as production managers and want to gain good experience in the field of Good Manufacturing Practices (GMP).
- Individuals working in the pharmaceutical industry
- Individuals working in the food manufacturing field
Course Outlines :
Unit 1 : What is GMP, its importance, and the relationship of GMP to facility design
- What is the importance of Good Manufacturing Practices (GMP).
- GMP history
- GMP – rules and guidelines
- European Union (EU) GMP and EU GMP Guide
- GMP in the United States
- Other GMPs from around the world
- Design of buildings and facilities
- Design appropriate buildings and facilities
- Heating, ventilation and air conditioning systems
- Access, security and pest control
- Equipment, maintenance and calibration
- Equipment selection and installation
- Planned preventive maintenance (PPM)
- Calibration of measuring devices
- Validation, qualification and change control
- Differences between validation and qualification
- Different verification stages
- The importance of controlling changes
- Water systems
- Different types of water
- Water system design, construction and monitoring
Unit 2 : The practical application of GMP – materials received for product release
- Procurement, incoming materials, suppliers and outsourcing activities
- GMP requirements for incoming materials
- Supplier selection and control
- Controlling outsourcing activities
- Warehouse
- Control of incoming materials
- Storage of materials
- Issuing materials for production
- Monitoring rejected and returned materials
- Manufacturing
- Different types of dosage forms
- Initial checks of the area, equipment and materials
- Documentation and records
- Report problems
- Cleaning equipment and area
- Packaging
- Packaging equipment design and facility layout
- Material and product control
- Overprinting of the artwork
- Quality Control
- Good control laboratory practice
- Test specifications and pharmacopoeia
- Validation of the analytical method and method transfer
- Recording results and issuing materials
- Continuous storage stability and testing
Unit 3 : GMP and quality management system
- People and training
- Organizational charts, job descriptions and training records
- GMP, hygiene and vocational specific training
- Training design and evaluation
- Key employees in GMP
- Heads of production, quality control and qualified person
- The role of quality and quality assurance
- The importance of senior management
- Documentation, records and data integrity
- Monitoring and approving documents and records
- Data integrity and regulatory concerns
- Use of computer systems
- Quality risk management
- The need to make risk-based decisions
- ICH Q9 and its requirements
- Reactive and proactive risk assessments
- Deviations, accidents and complaints
- CAPA systems – good and bad points
- Analysis of problem solving and root causes
- Handle complaints effectively
- Specific GMP requirements for specific types of products
- Manufacture of sterile products
- Biological products
- Advanced medical treatment products
- Quality Management System
- Review and release the payment
- Review product quality
- Internal audit
- Management review
- Continuous improvement
- ICH Q10 requirements
European Business Center Training Methodology :
Our training work is presented in a professional and attractive manner.. Interspersed with interceptive information to renew attention throughout the training period… We aim with this method to train the listener and interact… In addition to practical applications that target the direct skills and knowledge required to be achieved.. It is presented to the trainees in more than one way.. Practical exercises and applications.. Surveys and questions.. A training strategy has been adopted based on pairing between the theoretical and the professional and between the local and the global.
What Does The Participant Get From The Course?
Each participant obtains an internationally accredited training certificate from the European Business Center for Training and Development … which has the ISO certificate in quality No. 9001/2015 from the English international company UKAS .. and receives a training bag containing the scientific material via an electronic flash … in addition to an enjoyable and useful training that is reflected Positive and developmental for individuals and the institution
Note :
We can implement the training course in any of the cities referred to in this course..at the appropriate and required time for the trainees..through joint coordination with the training department at the center..the training is implemented in a distinctive manner according to the best quality standards so that we meet all training requirements and needs.
International Accreditations
European Business Center for Training and Development has obtained international and official accreditations with the highest and best international levels scientifically and technically, which reflect the level of outstanding performance in our training work.. so that it achieves what each participant aspires to by obtaining the best certificates with officially approved scientific and technical standards.
