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•A range of adjustable and exclusively dedicated services:
- To health industries: pharmaceutical, chemical, cosmetics industries and medical device manufacturers,
- To their suppliers: raw materials (API, excipients and intermediates), primary and printed packaging materials, service providers (analysis, cleaning, metrology, security, transportation, sterilization, temporary agency...).
• 5 main lines of "tailored" services:
- Quality Audit (on your site or on your suppliers and partners' site)
- Consultancy, support for quality projects and personal coaching,
- Training (face to face or e-learning, educational games ...),
Some examples of achievements:
•Quality audit processes:
- Quality control (on site and/or analytic outsourcing)
- Pharmaceutical storage and distribution,
- Transport and distribution,
- Archiving ...
- Shared quality audits for suppliers ...
• Consultancy, support for quality projects and personalized coaching:
- cGMP-FDA compliance of various production sites (medicines, medical gases, biotechnology, medical devices, API, cosmetics...)
- Support before, during and after inspection by the various regulatory authorities (compliance, coaching, action plan, answers to authorities, injunctions, warning letters ...),
- Drawing up Quality Manuals,
- Compliance with ICH Q10,
- Optimization of deviation management and CAPA processes,
- Quality Risk Management (ICH Q9)
- Implementation of the associated policy,
- Application of different risk analysis tools,
- Achieving your Products Quality Reviews,
- Reagents expiration/validity limit determination methodology,
- Design of Site Master Files,
- Documentary system optimization and revamping of batch records,
- Writing and translation of technical supplier's specifications ...
• Training (authorized to provide "DPC" programs):
- Design and / or animation of customized training modules: face to face, e-learning or self-training courses (MyPower),
- knowledge assessment, authorizations,
- Training Plans Construction
- Design of educational games (Rubis, Revisions Utile des BPF sous forme interactive et sympathique...),
- Design and declination of knowledge evaluation processes (samplers, ZAC operators, trainers and tutors...).
- Support for your validation and revalidation strategy,
- Construction and / or performing criticality analyzes
- Assistance for equipment qualification and re-qualification processes,
- Drawing up validation protocols: processes, cleaning, sterilization...
- Supervision of tests on your premises or those of your suppliers.
- Quality Tools "GMP manual", "5 words more...", "Maqadm Health, audit quality matrices"...
- Design of welcome booklets and quality of information supports: posters...
- Self-training courses,
- Benchmarks 5m Partner.