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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 & GMP compliance
GDP with specialties in sterile manufacturing
HVAC systems & cleanroom design and construction
ATMPs
With deep expertise in cold chain monitoring Dirk partners with pharmaceutical and life science companies to ensure product integrity from production to patient.
Clear Guidance: Breaks down complex concepts into simple, actionable insights.
Hands-On Approach: Provides real-world examples to help solidify your understanding.