Ashley Isbel – Validation Services Director, PharmOut Pty Ltd
Among Australia’s leading experts in both GMP validation and sterile manufacturing compliance, Ashley offers 25 years of practical experience as a qualified Chemical Engineer in GMP-regulated industries (TGA, PIC/S, FDA), including pharmaceuticals, pharmacies, medical devices, ATMPs and blood & tissue organisations.
Ashley has trained regulatory agencies as well as supported start-up companies to find their way through 21 CFR 820, 21 CFR 11, PIC/S, ISO 13485 and 14644. His expertise includes validation, process engineering and GDP and GMP compliance, with specialties in sterile manufacture, HVAC systems and cleanroom design and construction.
Ashley routinely conducts practical gap analysis, performs design reviews and inspections to assist companies to develop compliance road maps.