About Us
Background
- Validation Consultant
- Project Manager
- Package Design: New or Re-designs
- Tray & Lid-Tyvek, Foil
- Pouch- Tyvek, Film, Nylon, ALOX
- Altered Atmosphere (Vac-Gas)
- Package Testing
- Aging, Sterilization
- Transit
Working knowledge
- FDA 21 CFR 820 Quality System Requirements
- European Medical Device Regulations
- ISO 13485, 14971, 11607 Standards
- Supplier Quality Systems
- ASTM Methods
- MDSAP
Specialties
Internal auditing
- Quality Systems
- Suppliers
Validations for all packaging systems
- Tray Sealer
- Pouch Sealers
- Form-Fill-Seal
Advise, help and guide
- To improve quality systems and package testing
- Package Lab Testing Establishment of
- ATMV - Attribute Test Method Validations
- VTMV - Variable Test Method Validations
Write and execute protocols
- IQ, OQ, PQ, PPQ
Contact Us
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