Validations and Verifications
Provide scientific support for assay, method, equipment, or process validation for in-house testing and external studies. This includes designing, executing and summarizing validation studies for microbiology assays, flow cytometry, chemistry, serology, and other analytical lab assays, equipment, or processes.

Past Projects: Equipment / Assays

• Abbott Alinity
• Procleix Panther
• Bio-Rad Readers, Washers
• Roche COBAS
• Liquid Chromatography (LC) / HPLCs / UPLCs: Waters, Agilent, PerkinElmer, Shimadzu
• Gas Chromatography (GC)
• Mass Spectrometry (MS)
• Method Verification and Suitability
• Compendial Method Verifications
• Infectious Disease Serology and NAT
• Manual Testing Methods (ABO, Agglutination, Western Blots, RIBA, EIA)
• Microbiology: Compendial verifications, Suitability, Method modification.
• Chamber Mapping Validation Review
• Design of Experiment (DOE)
• Re-Validations

CAPA Coordination

• CAPA Coordination and RCA subject matter expert
• Assess CAPA systems and contribute to current CAPAs to drive closure
• Assess risks (FMEA) and develop solutions
• Manage project timelines for CAPA owners
• Maintain regulatory compliance and cGMPs

Audit Readiness

Checklists:

ISO 13485 – Med Device

ISO 17025 – Testing and calibration

ISO 9001 – General QMS

FDA 210/211 – Pharmaceuticals

FDA 600 – Biologics

FDA 820/QMSR – Med Device

FDA 1271 – HCT/P

AATB

AABB

General Gap Analysis/Systems Integrations

Third-party Quality Management System Audit

FDA 483 / Warning Letter Remediation Projects

• Technical contributor re-validating high-volume sterile production processes for an international Medical Device company
• Project Management/Oversight consulting
• Document review, gap and risk analysis, re-validation (authored protocols and reports), technical writing and compliance coaching
• Thoughtful integration of systems to drive continuous Improvement (CI)

Training

• Train the Trainer Programs
• Annual cGXP
• Training Systems Evaluation
• Technical Procedure-based Training

Quality Management Systems Design and Implementation

Existing Systems:

• Consolidation
• Integrations
• Gap Analyses
• Compliance Evaluations

New Systems:

• AI-Backed System Evaluation and Implementation
• Validation and Verification
• Training
• Continuous Improvement Integration
• Effectiveness Checks