Diane Raccasi, B.S

Diane Raccasi, B.S

Diane Raccasi, B.S

Principal Consultant

Ms. Raccasi has 11 years’ experience with FDA in CDER and ORA. CDER experience included Guidance and Policy development, CGMP Compliance (e.g., 483 review, drafting of Warning Letters, inspection assessments and conducting inspections), and Biologic License Application (BLA) assessment (e.g., application review and led pre-approval inspections). ORA experience included implementation of injunctions, seizures warrants and participation in criminal cases.

Diane’s FDA experience included lecturing as an ORA, Basic Drug School instructor with lectures on, Cross Contamination (penicillin and potent compounds), Microbiology Laboratory Inspection Approach and a Pharmaceutical Microbiology Course for laboratory staff with an emphasis on Sterility, Endotoxin and Bioburden. Technical working group experience included the Sterility Analytical Manual, Pharmaceutical Microbiology Manual Chapters, Antimicrobial Effectiveness, Microbial Examination of Non-Sterile Products, Sterility Testing, Particulate Matter, Bacterial Endotoxin Testing, Environmental Monitoring and Device Bioburden.

Diane has experience in development of multiple FDA Guidance’s for Industry, and technical documents. As well as expert knowledge of USP, ICH Guidelines, ISO, FD&C Act, 21 CFR 210, 211, 601 and other FDA regulations.

Work experience

Diane spent 5 years in the bio-pharmaceutical industry in multiple roles related to clinical trial testing, assay development, quality systems, and validation of analytical methods. In addition, Diane spent 4 years working as an Enteric Epidemiologist characterizing disease trends on bacterial and viral surveillance data as well as coordinating outbreaks between state and federal agencies.

Prior to joining PAREXEL, Ms. Raccasi was a Senior Microbiology BLA Reviewer for CDER/OPQ/OPF/Division of Microbiology Assessment at the FDA.

Education

Diane holds a B.S. in Microbiology from Weber State University.
 

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