GMPhar Consultants for the Industry
Pharmaceutical, Medical Devices
Cosmetic and Food




normas GMP&L

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La Importancia de la Validacion

Microbiológica en los Sistemas de

Agua Purificada 

Por la Dra. Nora Rabinovich

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Address: Gualeguaychu 1718/20 (C1407ALL) Ciudad Autónoma de Buenos Aires - Argentina. Tel.:+54(11)4566-4968/4504-5641

-GMPhar Consultants for the Industry Training & Courses-

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.


  • cGMP, in different levels.

  • Clean Rooms and new technologies.

  • Management, integration between investigation and development staffs.

  • Maintenance of basic equipment and manufacturing process.

  • Packaging in Medical Devices and Pharmaceutical industries.

  • Sampling. Methods in Microbiological Quality Control of sterile and no-sterile products /items.

  • Validations of methods.

  • Interpretation of O.O.S. results.

  • Aseptic Filling Process and their Validations.

  • ISO 14644, attachment I and II, for Clean Areas.

  • Treatment of Purified / WFI water systems. Biofilms. Validations.

  • Endotoxins, LAL test. Depyrogenation. Methods, Limits and Validations.

  • Sterilization: products, raw materials, glassware. Different systems. Validations.

  • Antibiotic Potency Testing. Statistic calculations.

  • Others.

Didactic material: CDs

To further information about the developed index for each course, cost and supplementary data, contact to:

We also offer training of your staff at your own facility.

The courses may be dictated in any Spanish-speech country, through special agreements with private or public organizations.