ROBERT J. WHERRY, MSc, MS, CPIP
VP OF AI COMPLIANCE
CENTER OF EXCELLENCE
Mr. Wherry has 42 years of international pharmaceutical, biotechnology and medical device experience with expertise in Quality Systems, Design Control, Computerized System Validation, Data Integrity Audits & Remediation, Quality Systems, Process Validation, Aseptic Processing, Regulatory Operations and eCTD submissions. Bob is a chemical engineer (Lehigh University), with a MSc in Pharmaceutical Quality (University of Strathclyde) and a MS in Regulatory Affairs (Northeastern University). He has also studied artificial intelligence and machine learning at MIT.
Bob provides compliance consulting services including quality system design, gap assessments, mock inspection audits, vendor audits, data integrity assessments & remediation, computer validation, GxP compliance assessments and training, process development and process validation, CMC & Module 3 assessments, regulatory strategies, and compliance approaches for artificial intelligence and machine learning.