Steve Williams

Background

About Steve Williams

With more than 45 years experience in the Biotechnology, Pharmaceutical and Medical Device industries, Steve provides strategic solutions to regulatory and compliance challenges, along with advanced training courses. He works across the Asia Pacific with a particular focus on Hong Kong and China. He has over 25 years consulting experience in GMPs, Compliance, Auditing, Training and Quality Systems to all international standards. Recent projects include international (FDA/PICs/TGA/DoH) GMP compliance, quality systems, risk management, gap analysis and CAPA implementation in Biologics, Sterile Manufacturing and Plasma Products. Steve has developed multiple training courses in GMP, GLP, Validation, Risk Management and Quality Systems. He also assists companies in remediation programs and prepares companies for regulatory inspection. As a registered auditor for the Australian Pesticides and Veterinary Manufacturing Authority Steve conducts Government GMP licensing audits for veterinary manufacturers in Australia and overseas. He has also served on the International Board of Directors for the ISPE.