Manuel M. Garza

Manuel M. Garza

Manuel M. Garza

Principal Consultant

Manuel’s cGMP expertise includes his 27-year career as an FDA investigator, including 18 years performing foreign PAI and GMP inspections of sterile and not sterile pharma manufacturers, both API and finished dosage forms, worldwide and 5 years as the district PAI manager. 

Work Experience

In his current capacity as a Parexel Principal Consultant he has advised and guided clients in preparation for and successful completion of FDA inspections. He performs and leads teams in Mock PAIs, Mock Systems Inspections and performs general risk assessments; analysis and remediation of complaint, adverse drug experience and deviation investigation systems; CAPA systems; change control systems; manufacturing control systems; visual inspection systems; air flow visualization systems (smoke studies); and equipment cleaning, sanitization and sterilization systems. During these activities he assists clients in the development of mitigation strategies for monitoring and controlling risk pending completion of CAPAs and proposed change controls.

Education

Manuel has a BS in Biology, University of Texas-Pan American. Member of PDA and ISPE.

We are always available for a conversation.

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