Trainings in scientific development and production center FAVEA
The principal value for quality assurance of products is not only a high level of manufacturing but high qualified personnel acquainted with GMP rules and standards. Scientific development and production center FAVEA in Koprivnice, Czech Republic, proposes trainings for pharmaceutical personnel about all aspects of GMP and quality assurance.
The main intention is improvement of basic professional knowledge in the field of modern technological achievements, production and quality control.
Important task of training is creation of firm quality assurance conception, its optimization and development.
Necessary remark is that such training is a kind of basis which helps personnel to start up the system of self-education, renewing knowledge and experience exchange.
Center bases on objective scientific estimations and methods for assurance of European level of training for pharmaceutical professionals and production quality guarantee.
Training Programs
1. QA - Quality Assurance and QC - Quality control
pharmaceutical QA system
basic requirements to QA manager
permission for shipment of goods
essential documentation and document flow control
QA in liquid dosage forms production
reclamations and recalls
realization of modifications
QA and the system of information
contract manufacturing and control
internal quality audit
audit of suppliers
GLP in control laboratories
quality monitoring
variability in drug manufacturing
validation of analytical methods
review of analytical methods
chemical analysis
physical analysis
microbiological analysis
2. Validation
conception and organization of validation
Validation Master Plan
qualification of equipment
calibration and metrology
validation of homogenization processes
validation of water systems
cleanrooms qualification
cleanrooms validation
microbiologic aspects of validation
validation of chemical sterilization
validation of cleaning processes
documentation validation
3. Cleanrooms in pharmacy
basic definitions and principles
design of cleanrooms
cleanrooms components
code of behavior for cleanrooms
dress code and disguise in cleanrooms
personnel and material airlocks
cleaning and sanitation procedures
isolators
regular and preventive maintenance of cleanrooms
cleanrooms monitoring
4. Pharmaceutical industry
classification of pharmaceutical production units
Site master File
CIP and SIP stations
sterilization procedures
preparation of raw material
preparation of liquid dosage forms
tableting and powdering
production of pharmaceutical substances
Drug Master File
pollutions and methods of purification
requirements to premises and equipment
storage system
document flow control system
central documentation department
documentation flow in firm
archivation of documentation
original documents and copies
realization of modifications
SOPs and another documents
models of SOPs
"what is not written does not exist!"
5. Pharmaceutical water
TW
PW
WFI
preparation of water
Distribution loop
validation of feed water
chemical monitoring
microbiological monitoring
sterility and apirogenicity, test methods
components of water systems
6. Microbiological principles. Procedures of cleaning and disinfection
basic characteristics of microorganisms
principles of microbiologic ecology
microbial contamination in pharmacy
microbial indicators
microbiologic estimation of raw materials and non-sterile production
methods of cultivation in laboratory
methods of quantitative estimation
sterility tests
pyrogenous substances
microbiologic estimation of pharmaceutical water
principles of sterilization
disinfection and preservation
efficacy of antimicrobial substances
7. Coach to coach
Value and strategy of training
conception of training in production unit
selection and education of coach
methods of training
school programs and supporting materials
personal reports and presentations
managing abilities
human resource management
team work
manager's activities
This year “Platinum Ounce” award in the special category of the organizing committee for the “Successful implementation of projects on modernization of pharmaceutical production in Russian Federation in accordance with the standards GMP” received company FAVEA
The worldwide most important document in determining the requirements for production and quality control of medicines for humans and animals is "Good Manufacturing Practice for Medicinal Products (GMP)".
Validation
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GMP Training
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