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Training

Training

In a regulated environment it is always necessary to follow any normative or technological changes. At Inntegrapharma, we offer in-company training that perfectly blends theoretical concepts with practical implementation.

The training that we offer at Inntegrapharma helps companies make sure their quality systems and installations are ready for new business opportunities. This training isn’t only theoretical we will also support our clients in the implementation of each of changes.

High risk toxicological product management. Containment

We look at how to approach the introduction of high-risk toxicological products, risk analysis, technical containment solutions, operative solutions, installation adaptation, processes and procedures.

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Requirements for sterile products

Technical, operative and procedural solutions for the manufacture of sterile products.

Adapting existing areas or designing new area to meet the updated national and international laws (FDA, EMA, COFEPRIS, ANMAT, ANVISA, ANVIMA,CFDA…)

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Biosecurity

Technical, operational and procedural solutions for the biological containment in areas of research, analysis and industrial diagnosis or production. 

Adaptation of existing areas or designing new areas based on international and national regulations (EU, CDC, OIE, WHO, FAO…).

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Stages of a new pharmaceutical Project

  • Business viability study (Business plan)
  • Conceptual design
  • Project management/engineering/construction 
  • Construction and installation process 
  • Commissioning, qualifications and validations 
  • Pharmaceutical development, transfer and registers 
  • Industrial manufacture

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Product transfer

  • Search for national and international CMOs 
  • Process transfers
  • Transfer analytics
  • Regulatory support

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Technical management

  • Implementing technical directors and technical managers
  • Adapting to technical needs and dedication
  • Training in technical management

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