Services Include (but are not limited to*): Audits Quality System Review: Gap Analysis Supplier Qualification CLIA Survey Preparation FDA GLP, cGMP (Biopharma & Medical Device) Compliance Consulting Document Generation/Review/Revision (SOPs, Policies, Plans) Change Control Systems OOS (Out of Specification) Investigations CAPA (Corrective Action/Preventative Action) Systems Deviation/Discrepancy Systems Quarantine and Release Programs Pre/Post Inspection Plans Corrective Action/Remedial Action Plans Start-Up Business Quality (QA) Consulting Training On-Site Annual GLP/cGMP Training Sessions Validation Protocol Generation/Execution

*If you require a service not listed above, please contact us regarding your project and we will discuss our experience and your options!

Lab Quality Resources, LLC