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Services
QA Consulting
Our QA team covers the full GxP scope (GMP, GDP, GPvP, GCP) and supports clients in the following areas:
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Quality Management System implementation and improvement
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Quality auditing
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Subcontractors / Vendors / Suppliers / Manufacturers / Partners' selection and management
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Non-conformities management (deviations, out of specification results, product quality complaints, audit / inspection findings, recalls)
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Continuous improvement (individual projects and CAPA management)
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U.S. / EU Inspection readiness assessment
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Validation / Qualification
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Training management
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Document management
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QA team training and coaching
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Raw materials and consumables selection and release
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Batch record review and release
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Change control
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Risk analysis
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Storage and shipping
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Facility design
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Aseptic operations
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Business Continuity Plan
Looking for something else? Please, let us know.
US-EU Bridging
Our team is composed of European and American quality experts. We are the ideal partner for companies interested in exporting, importing or establishing themselves in Europe or North America. We offer comprehensive GxP solutions locally and internationally, providing our clients with our expertise and resources.
GxP Academy
We propose quality-related training to companies and individual professionals eager to develop their skills and advance their careers.
Good Manufacturing Practices (GMP)
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Introduction to GMP
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Advanced GMP training
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GMP auditing
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Aseptic processes
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Differences between US and EU GMPs
Good Distribution Practices (GDP)
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Introduction to GDP
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GDP auditing
Good Pharmacovigilance Practices (GPvP)
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Introduction to GPvP
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GPvP auditing
Good Clinical Practices (GCP)
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Introduction to GCP
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GCP auditing
Across disciplines
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Quality Management tools
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Auditing - core principles
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Validation / Qualification
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Good Documentation Practices
Interested in our training? Please, contact us for more information.