We organize public seminars accessible to all professionals in pharmaceutical andcosmetic industry and the production of medical devices.
For a larger group from one company, it is more advantageous to plan a tailor-made training, training or workshop.
Training, seminar or workshop can be intended for
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Introductory training for new employees or graduates of secondary and higher education
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Regular GMP training
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Topics that are new to the company and employees
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New legislation and regulations
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Repeated findings from audits and inspections
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Expanding employee specialization
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Increasing the qualifications of employees
Objectives of our seminars, trainings and workshops
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Increasing the prestige of the entire company
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Constructive communication with customers and suppliers
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Highly professional communication and discussions with inspectors and auditors
Circuits of seminars, trainings or workshops
GMP for beginners - introductory training for new workers agraduates
GMP for advanced and recurrent regular training
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EU GMP Part I
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EU GMP Part II (ICH Q7)
Overview of legislative requirements for pharmaceutical production
Registration in EURASIA and LATAM countries
Registration in MEN and APAK countries
Biosimilars – regulatory framework for biological products (EU)
Provenance of origin and protection against "fake drugs"
Quality Control
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Management of the laboratory and its processes
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Life cycle of an analytical method in GMP
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Analytical methods – transfer and validation/verification
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Qualification of laboratory instruments
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Methods of proper weighing and pipetting
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Impurities
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Stability program
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OOS, OOT and OOE
Pharmaceutical microbiology
Endotoxins
Microbiology "for non-microbiologists"
New Annex 1 – Production of sterile drugs
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Clean spaces
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Sterilization
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Staff, behavior and dress in clean areas
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Monitoring procthe third
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Sanitation and disinfection program
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Contamination Controll Strategy
Annex 15 – Qualification and validation
Clean media – PW, WFI, clean steam, clean gases
Cleaning and cleaning validation
Process validation
Technology transfer
Risk assessment
Evaluation of suppliers
Data integrity
GMP audit – preparation, completion, conclusions – practical example
GDP, cold chain management
Stainless materials in the pharmaceutical industry
Drug life cycle
Principles of tablet compression
Solid phase studies for pharmaceutical purposes
Statistical processing of data in the pharmaceutical industry
Upcoming events
No events at the moment
We will be happy to prepare training for you exactly tailored to your needs!