Food and Drug Administration

Pharmaceutical Science Advisory Committee

Process Analytical Technology Subcommittee

October 23, 2002

Slides

Opening Remarks, Dr. Ajaz Hussain, PhD, FDA (HTM) (PPT)

Challenges of PAT System Implementation, R Chisholm (HTM) (PDF) (Word)

Computer Compliance: Expectations & Experiences, Dr.Guy Wingate, GlaxoSmithKline (HTM) (PPT)

Electronic Records; Electronic Signature (HTM) (PPT)

CDFH Software Regulation, John Murray, Jr., FDA (HTM) (PPT)

PAT for Drug Substance Particle Size Monitoring - A Process Development Case Study (PDF)

Validation Perceptions That May Slow PAT Development and Implementation, Steve Hammond, Pfizer Global Manufacturing (HTM) (PPT)

Validation of Rapid Microbiology Systems, Jeanne Moldenhauer (HTM) (PPT)

Why Does PAT Need Rapid Microbiology Methods?, S. Lonardi, P. Newby, D. Ribeiro, B. Johnson (HTM) (PPT)

Open Public Hearing

The Interrelationship Between PAT and Six Sigma, Dr. Stanley Marash, P.E., Stat-a-Matrix/The SAM Group (HTM) (PPT)