We offer periodical seminaries and courses about related items with the Pharmaceutical, Medical Devices and Cosmetic industries.
In particular, but not exclusively, they include Microbiological Quality Control, in lab and manufacturing facilities.
The seminaries/courses are directed to all the personal, quality control annalists, Managers, Directors, Engineering or Maintenance staff, related
or participating in the corresponding subjects, and they intend to train
or improving the knowledge required to every one, deeping understanding
the interaction between the microbiology and the engineering
equipment/system designs and the environmental control and hygienic
performance.
The integration between Microbiology and Technology allows adding
chemical-pharmaceutical targets with hygienic results consistent with health. That means, working with cGMP rules.
LIST OF COURSES
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cGMP, in different levels.
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Clean Rooms and new technologies.
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Management, integration between investigation and development staffs.
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Maintenance of basic equipment and manufacturing process.
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Packaging in Medical Devices and Pharmaceutical industries.
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Sampling. Methods in Microbiological Quality Control of sterile and
no-sterile products /items.
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Validations of methods.
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Interpretation of O.O.S. results.
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Aseptic Filling Process and their Validations.
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ISO 14644, attachment I and II, for Clean Areas.
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Treatment of Purified / WFI water systems. Biofilms. Validations.
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Endotoxins, LAL test. Depyrogenation. Methods, Limits and Validations.
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Sterilization: products, raw materials, glassware. Different systems.
Validations.
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Antibiotic Potency Testing. Statistic calculations.
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Others.
Didactic material: CDs