Steve Williams Email & Phone Number

Australia

CBE brings together a team of senior industry consultants with extensive and practical industry experience in key areas of biopharmaceuticals operations. CBEs mission is to ensure our clients success by delivering value added internationally experienced consulting services together with operational excellence and enhanced regulatory compliance. CBE provides consulting services in the Asia Pacific region to all international regulatory standards. CBE has capability across many sectors including biologics, blood products, vaccines, APIs, drugs, sterile products and medical devices. Our core skills include:- Compliance and quality systems gap analysis / audits to FDA, EMA, PICs and TGA standards;- Development of R&D and operational strategies for the registration of biologics, blood products and new entities;- Blood collection centre and plasma processing operations;- Facility and cleanroom design, engineering solutions and C&Q / Validation oversight including oversight of new production line installation and start up- Operational excellence, and process improvement;- Organisational Improvement and Culture;

Melbourne, Australia

Melbourne, Australia

Director:SWA Biopharm P/L - (Compliance by Design)CBE P/L (Biopharmaceutical Asia Pacific)

Managing Director and Senior Compliance Advisor specialising in TGA, PICs and FDA compliance for Biotech. Drugs and Devices.

Melbourne, Australia

Consulting role as Senior Quality and Compliance Advisor to CSL Behring - Bioplasma. Provides expert consulting on quality and compliance matter in relation to FDA, TGA, PICs GMPs and ICH Q8, 9, 10 and 11.

Mebourne Australia

Performed multiple project and management roles as a consultant for CSL Behring including:- Sterility Assurance Consultant (18 months)- Interim Site Quality Director (12 months)- Compliance Improvement Programs (12 months)- New FDA Project Compliance Advisor (12 months)- Part time QC Laboratory Manager (9 months) in charge of Analytical, Immuno-chemistry and Microbiology Laboratories.- Consultant FDA Validation Systems

Australia

Conduct GMP audits on behalf of the Australian Pesticides and Veterinary Medicines Authority (APVMA) in Australia and overseas. In this role I conduct GMP licensing audits under a professional services contract on behalf of the Australian Government.

Asia Pacific

Over the last 25 years I have developed and delivered over 100+ education and training courses for biopharmaceutical professionals both in-house and public workshops and seminars. Experience includes:- ISPE Continued Pharmaceutical Industry Professional (CPIP) committee member for 4 years- Initiated public GMP & Quality Management Training courses in Australia - Established industry GMP/Quality accredited professional programs in Malaysia- Long term Professional trainer to the Hong Kong Pharmaceutical Manufacturers (HKPMA)- Regular Trainer for DCVMN (International Vaccine Network) in Asian region (WHO- PQ)- Presents regularly at industry conferences regionally on GMP Compliance, QRM and PQS- Designed/delivered multiple short courses for industry clients in compliance, GMP, GLP, GAP etc

Victoria, Australia

Founding Partner and Senior GxP consultant for SeerPharma P/L for over 20 years. Specialised in GxP Compliance, Quality Systems, Compliance gap analysis and Training.

Responsible for QA and Compliance to TGA, EMA and FDA licensing

Melbourne, Australia

Various management roles within CSL (now Sequeris) including:- Influenza Manufacturing- Antibiotic Manufacturing- Quality Control Laboratories (Chemistry and BioAssay)- Quality Assurance Management - Sterile Products - Fill and Finish