White Birch Consulting Services
Compliance Consultant
Robert Wherry, CPIP, has 39 years of experience in the pharmaceutical, biotechnology, and medical device industries, with expertise in compliance, computerized system validation, data integrity audits and remediation, quality systems, process validation, aseptic processing, regulatory strategy, and operations. Bob is a chemical engineer (Lehigh University), with an MSc in pharmaceutical quality (University of Strathclyde) and an MS in regulatory affairs (Northeastern University). He studied artificial intelligence/machine learning (AI/ML) at MIT. Bob serves as a State Representative in New Hamp-shire and is the owner of White Birch Consulting Services, LLC. Consulting services including ISO Standard gap assessments, mock inspection audits, vendor audits, data integrity assessments and remediation, computer validation, GxP compliance assessments and training, process development, and process validation, CMC/Module 3 assessments, and regulatory strategies. Recently, he developed compliance and design control frameworks for AI/ML for both medical device and pharmaceutical companies. He has been an ISPE member since 1996.
