Former FDA Pharmaceutical Drug Expert
Terri Dodds
Sterile product and environmental monitoring specialist who evaluates technology transfers, scale-ups and validation plans.
- Sterile
- Environmental Monitoring
- Technology Transfer
- Validation
- CMO Audits
16 years FDA; 7+ years consulting
Background
Terri Dodds was with the FDA for 16 years, primarily as a Pharmaceutical Drug Expert, and brings more than seven additional years of consulting to industry. Beyond pharmaceuticals, her expertise extends to medical devices, biotechnology and clinical studies.
She performs mock-FDA audits, sterile product audits including environmental monitoring evaluations, Warning Letter and strategic regulatory consultation, CMO and CRO audits, and the evaluation of technology transfers, scale-ups and validation plans.
What Terri does on an engagement
- Sterile product and aseptic processing audits
- Environmental monitoring program evaluation
- Technology transfer and scale-up assessment
- CMO and CRO qualification audits
- Validation plan review
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