Former FDA Investigator — BIMO, GMP & GCP
Jennifer Menendez
Conducted inspections across all product areas during a decade at FDA and was considered an expert in BIMO, GMP and GCP audits.
- BIMO
- GCP
- cGMP
- Biologics
- CAPA
18+ years combined; 10 years at FDA
Background
Jennifer Menendez has more than 18 years of combined FDA and industry experience across pharmaceuticals, medical devices, biologics and bioresearch clinical regulatory requirements. During her ten-year tenure with the FDA she conducted inspections covering all product areas and was considered an expert in BIMO, GMP and GCP audits.
She is regarded as an expert in assessing compliance issues and implementing the corrective actions and quality systems that actually resolve them, rather than documenting them.
What Jennifer does on an engagement
- BIMO, GMP and GCP audit programs
- Compliance assessment across drug, device and biologic operations
- Corrective action design and effectiveness verification
- Clinical quality system implementation
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