Laurie Predom

Background

About Laurie Predom

LP Technical services over 35 years of multidisciplinary contributions to the Biomedical and Pharmaceutical manufacturing fields, while demonstrating high levels of project management with strong experience in the following Engineering/Validation and Quality roles. 25+ years in biotechnology platforms, developing, executing and summarizing (IQ, OQ, PQ and SOP’s) on ‘state of the art’ and legacy pharmaceutical equipment and controls for long list of process equipment including ancillary equipment verifications and cleaning requirements. 25+ years specifically in the area of Quality Assurance/Quality Control, Regulatory Auditing for FDA/ UL/ CSA/ ETL. 15+ years Project Management facilitating of teams, coordination of Mfg, Engineering, and Sub-contractor efforts. 15 years thermal validation and reports with placement diagrams, specializing in Kaye setup, Wireless dataloggers (Ellab, EBRO, Datatrace) calibrations and operations. 20 yrs. Solid Dosage processing with fundamental understanding of quality philosophies and principles applied to Validation. Compliance verification for 503B Compounding mfg, 21 CFR Part 11 requirements, Environmental Cleaning and Sampling, Commissioning FAT/SAT testing. Proficient with current Good Manufacturing Practices (cGMP), Good Laboratory Practices (cGLP), practices. Coordinator of various project training (internal and external) with the client, trainers, and project team.