Experienced in auditing of Manufacturing Facilities,
Laboratories, Packaging, and Label Operations utilizing
GxP, CAP and CLIA Regulations, as Requested by
Client.
- Vendor/Contractor/Partner Audits: 21 CFR Part 820, IVDD (98/79/EC), MDD, Client Specified Regulations and SOP's
- Client Internal Audits: 21 CFR Part 820, IVDD (98/79/EC), MDD, Client Specified Regulations and SOP's
- FDA and EU Labeling Compliance Assessment
- Facilities, Equipment, and Computer Validation Support and Coordination
- Due Diligence Investigation of Potential Partner Companies/Contract Vendors
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