Dr. Thomas Catalano obtained his Ph.D. in pharmaceutical sciences at St. John's University in Queens, New York. He started his forensic career as a member of the New York City Police Department (NYPD) Crime Laboratory doing testing in various areas including drugs, gunshot residue, arson investigation, blood alcohol determination, glass analysis, soil comparison, inks and dyes analysis, paint chip analysis and explosive residue. Dr. Catalano published seven articles on various subjects while a member of the NYPD Crime Laboratory. After his time at the NYPD Crime Laboratory, he moved on to a career within the pharmaceutical industry, where he has held various positions-including the Global Sr. Director of Analytical R&D-with major pharmaceutical companies such as G.D. Searle, Pharmacia, Pfizer, and Theravance, giving him vast experience in providing analytical support to dosage forms, drug substances and biologicals. Dr. Catalano has made significant contributions to the development and registration of many products that are currently on the market. He is not only an expert in analytical chemistry but also in the FDA Guidances, guidelines, and work processes that are applicable to forensic chemistry. Currently, Dr. Catalano is president of PharmChem Analytical Consultants LLC., a consulting company that provides service to the pharmaceutical industry, food industry, and forensic chemistry.

Identifies the limitations of laboratory practices in forensic chemistry

Applies the concept of the "scientific method" to laboratory practices to enhance validity of results and conclusions

Reviews the guidances and work processes used in highly regulated industries (pharmaceutical, food, etc.)

1 Introduction.- 2 What is Science.- 3 Forensic Chemistry.- 4 Code of Federal Regulations (21CFR) Guidance's.- 5 International Committee on Harmonization (ICH).- 6 International Organization for standards.- 7 Statistical Considerations.- 8 Conclusions.