Phillip Perry Email Address

Senior Quality Specialist III, Quality Improvement, Quality Auditing

Purdue Pharma is committed to advancing the medical care of patients with quality pharmaceutical products.

Pharmaceutical and Health Care professional experienced in conducting audits of pharmaceutical companies and support organizations for compliance with internal and international regulations using Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), Good Laboratory Practices (GLP), International Conference on Harmonization (ICH), United States Food and Drug Administration (USFDA), and European Union (EU) principles as a Lead Auditor. I have expertise in auditing Clinical Supply Manufacturers and Contract Research Organizations. I also have expertise in the preparation and management of Chemistry, Manufacturing, and Controls (CMC) Section of New Drug Applications (NDAs). My job requires meticulous attention to detail in the analysis and interpretation of deviations, investigations, and change control with emphasis on root cause analysis and corrective action and preventive action (CAPA). PROFESSIONAL SKILLS-GMP regulations - NDA submissions-GLP regulations - Audit preparation, performance, and follow-up-GDP regulations - Due Diligence, Qualification, and For Cause audits -GCP regulations - Quality Guidelines/Regulations (ICH, USFDA, EU)-Report writing - Standard operating procedures (SOPs)-CAPA and Deviations - Investigations and Root Cause Analysis -Change ControlPROFESSIONAL DEVELOPMENTGLP Training – June 2006Right First Time Six Sigma & Process Analytical Technology Training – May 2007Aseptic/Vaccine Training – January 2009Global Aseptic Seminar – July 2009Microbiology Laboratory Training – October 2011Biotech Overview Training – March 2012Data Integrity Guidance and Considerations – October 2015NSF/IPEC/ANSI 363-2014 GMP – February 2016Internal Auditor Training for ISO 9001 – January 2017