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

Noviembre

EDUCACIÓN A DISTANCIA

PRESENTACIÓN DE CURSOS ON-LINE

normas GMP&L

ver demo en www.gmphar-cursos.com.ar

 

ver más información en 

 CAPACITACIÓN

 

 

La Importancia de la Validacion

Microbiológica en los Sistemas de

Agua Purificada 

Por la Dra. Nora Rabinovich

Click Aquí

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.

LIST OF COURSES

  • 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:

info@gmphar.com.ar

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.


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