Bob Haldane - Quality Assurance
Bob is a talented, versatile Engineer with a diverse background of 20+ years in pharmaceutical and medical device manufacturing environments. His degrees include a Bachelor of Science in Chemistry and an Associates of Science in Electronic Technology. Starting his career as a bench chemist led to roles in clinical supply packaging, quality management, internal and external auditing, equipment, and process validations. Dosage forms included solid dose tablets, softgel capsules, and sterile injectable products for clinical studies and commercial release.
Bob’s history of supporting regulatory compliance includes on-site and remote auditing of Suppliers and internal departments, generating documentation (SOP,CAPA, PFEMA, and PPAP), investigations as a MRB team member, production process trouble shooting, validation of process/equipment/utilities (DQ’s, FAT,SAT & IQ/OQ/PQ's and cleaning validations)and execution of Gage R & R studies. Solid understanding of manufacturing statistics including Process Capability calculations (Pp, Ppk, Cp & Cpk), Normality Testing, Transformation of Non-Normal Data Sets, and application of Operating Characteristic Curves to Sample Plans. Bob has been trained by Dr. Wayne Taylor in validation principles and statistical calculations