You can find all dates of this Education Course in this overview.
Sprecher
Dr Bettina Pahlen, Quality x Pharma Consulting
Dr Heinrich Prinz, Apceth
Dr Wolfgang Schumacher, formerly F. Hoffmann-La Roche
Zielsetzung
The course is designed for people who have no or only limited knowledge of GMP.
You get to know the most important pharmaceutical regulations and their importance,
you get a basic overview of GMP requirements in pharmaceutical production and
you become familiar with technical terms from the field of GMP and their meaning
Hintergrund
In the manufacture and quality control of medicinal products, compliance with the GMP rules is the decisive aspect for manufacturing high-quality products. For this reason, every staff member in the pharmaceutical industry has to be familiar with the basic GMP requirements. The relevant European GMP regulations define the following prerequisites:
In practice, many members of staff are often unaware of the contents and meaning of the different GMP requirements from Europe and the US and their consequences for product quality. During this course, speakers with long-standing experience in the training of employees introduce and explain the most important elements of a pharmaceutical GMP system in an easy-to-understand way.
Zielgruppe
The course is directed to staff from the pharmaceutical industry having no or little experience with the current GMP requirements. This includes both employees who, after their vocational training, enter the pharmaceutical industry and experienced colleagues who work for the first time in a GMP-regulated environment. Participation is also recommended for personnel from suppliers who have to understand the quality requirements of their customers.
Programm
GMP: where do we come from - where do we go to?
- Development of GMPs
- GMP: Goal and general ideas
- Types of regulatory documents and their meaning
- GMP regulation for APIs, medicinal products and excipients - a comparison
- Authorities and industry groups: ICH, PIC/S, EMA, FDA, WHO, APIC, ISPE, IPEC
- Comparison of US and EU regulations
- Differences between European and FDA view on GMP / GMP vs cGMP
- Typical expectations of FDA and European inspectors
- Quality Management System cited in the regulations
- General aspects of Quality Assurance
- How to implement and structure a system
- Responsibilities
- General aspects
- Qualification
- Key personnel
- Job descriptions
- Training (purpose, goals, contents, target groups)
- Planning and documentation of training
- General aspects and rules
- Hygiene programme
- Personnel flow
- Medical examination
- Contamination
- Monitoring
- Structure of documentation
- Responsibilities for the documentation
- SOP
- Documentation in the manufacturing process
- Documentation in the quality control
- Batch record review
- Annual report / Product quality report
- Specifications
- Deviations
- CAPA
- Change Control
- OOS
- Failure Investigations
- Self-inspections
- Main topics of ICH Q 9 / Part 3 EU GMP Guideline
- Risk management tools
- Use of risk analysis during qualification
- How to handle FMEA?
- Requirements for room and equipment
- Classification of rooms
- Sterile production/isolator
- Maintenance of hygiene
- How to behave during production
- Definitions: Qualification, validation, calibration, maintenance, risk analysis
- Organizing qualification and validation: the validation master plan (VMP)
- Steps in qualification studies: DQ, IQ, OQ, PQ
- Qualification parameters of typical types of
- equipment: Clean rooms, water systems, production equipment, analytical equipment
- Performing risk analysis: tools and practical tips
- Calibration: critical types of equipment
- How to build up a calibration system
- Maintenance: Requirements and system
- Validation of computerised systems
- General aspects and requirements
- Process validation
- Documentation of process validation
- Validation of analytical methods
- Documentation of analytical methods validation
- Regulators requirements
- The cleaning procedure
- Building up a cleaning validation
- Sampling
- Analytical tests
- Types of audits
- Requirements
- Dos and don‘ts for the auditee - How to survive audits?
- Performing audits and self-inspections
- Good audit practices
- Packaging/Storage/Transportation in the regulations
- Managing of packaging process
- What is necessary to regulate in a pharmaceutical company
- WHO good storage practice – elements and requirements
- Transportation as part of storage
- How to maintain the quality during transportation
- Regulatory requirements
- Responsibilities of QP and the pharmaceutical industry
- What measurements can be taken
- Strategies against falsified products
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Seminarprogramm als PDF
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