Ashley Isbel
GMP Services Director
About Ashley,
Arguably Australia’s leading expert in validation, Ashley offers over 20 years of practical experience as a qualified Chemical Engineer in GMP-regulated industries (TGA, PIC/S, FDA), including pharmaceuticals, pharmacies, medical devices and blood & tissue organisations.
Ashley has trained regulatory agencies as well as supported start-up companies to find their way through CFR 820, CFR Part 11, PIC/S, ISO 13485 and 14644.
His expertise includes validation, process engineering and GMP compliance, GDP, with specialties in sterile manufacture, HVAC systems and cleanroom design and construction and ATMPs.
Ashley routinely conducts practical gap analysis, performs design reviews and inspections to assist companies develop compliance road maps and support vendor audits.
