SERVICES PROVIDED:
Project Lead / Senior Validation Engineer
(FDA Compliance Contract)
04/99 - 06/01
Two year capital expansion project:
- Developed customer packaging equipment specifications, qualifications and Factory Acceptance Test documentation IAW customer SOP’s, cGMP and FDA guidelines (21 CFR Part 11 and 210/211).
- Documentation developed includes: QAP, TP, FS, E/FRS, DDS, FAT, ECIQ, ECOQ, EIOQ, PQ for Thermoform & Coldform Blister Packaging Lines 31, 35, & 36 (approx. 50 documents per line) (approx. $20,000,000 worth of equipment).
- Equipment validation interfaced with the following customer departments/personnel: Project Engineer, Packaging Manager, Production, Quality Assurance, Computer Validation, System Administrator, Environmental Health & Safety, and Maintenance.
- Coordinated/qualified/validated two high speed blister packaging lines using the newly developed qualification protocols. Protocol executions included black box testing. Responsible for writing summary closure reports.
- Packaging equipment includes: an UHLMANN 1070 Blister Thermoformer and C2205, C2305, C2404 Cartoner, a PESTER vertical carton accumulator, a PESTER over-wrapper, case packer, palletizer, CCL labelers, INTERMEC printers, GARVEN check weighers to name a few.
- All documentation was developed on the customer Microsoft Network.
- All specifications and qualifications developed were standardized and utilized by customer to support worldwide packaging line expansion projects at additional customer site nationally and internationally, etc.
Validation Services
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