21st Century Quality Management and Good Management Practices: Value Added Compliance for the Pharmaceutical and Biotechnology Industry

Steve Williams is Senior Partner and Director - International Education SeerPharma Pty Ltd, Australia. Steve has over 38 years experience in the biotechnology, pharmaceutical and medical device industries in quality assurance, manufacturing and consulting. He has conducted numerous FDA and EU/TGA/PICs compliance audits and gap analysis for many international companies as well as developed multiple training courses in GMP, GLP, validation, risk management, sterile manufacture, HACCP and medical device regulations. Steve regularly presents at conferences and industry seminars on a range of subjects relating to QA, risk management and GMP compliance. He also specialises in e-learning and compliance training solutions for the life sciences industry. Steve has successfully prepared multiple companies for FDA, EU, TGA, and PICS regulatory inspections over the last 20 years and has provided expert reports in GMP compliance for regulatory agencies and courts. He is also a registered auditor for the Australian Pesticides and Veterinary Manufacturing Authority (APVMA) and, in this role, conducts GMP licensing audits on behalf of the Australian government.

• International rules and regulations in the life science industry; Pharmaceutical quality management and quality systems (ICH Q10); Fundamentals of good manufacturing practices (GMP); Validation; Pharmaceutical quality risk management (ICH Q9); Building quality into products (ICH Q8 and QbD); Process control and process analytical technology; CAPA, failure investigation and root cause analysis; Effective training and education; Behavioural GMPs, deviations and human error reduction; Supply chain integrity; Compliance auditing and product reviews.