Paul Kerr
PAUL KERR
Partner & Senior Consultant – Melbourne

Paul has over 35 years broad pharmaceutical experience across various technological areas (Laboratory, Manufacturing and IT) as a chemist and an IT project manager. As a qualified Software Supplier Auditor (PDA TR 32) Paul conducts IT gap analysis and compliance audits for companies (ISO/IEC 9000-3, ISO/IEC 62304, ISO/IEC 12207). He trains in computer validation (US FDA 21 CFR Part 11 and GAMP) and assists companies establish IT compliance and computer validation programs. Paul also conducts simulated FDA and TGA compliance audits and gap analysis for several international medical device and pharmaceutical companies (US FDA 21 CFR Part 820 and Part 11, PIC/S Annex 11, ISO 13485, ISO 14971). He regularly gets involved with specific validation projects using automated systems in clinical, manufacturing and laboratory environments.

Ian Lucas
IAN LUCAS
Partner, Senior Consultant and Software Solutions Manager – Melbourne

Ian has over 30 years experience with software development and implementing computerised systems. He has successfully designed and implemented many quality management and manufacturing solutions for the pharmaceutical industry and other regulated industries. Ian manages the Software Products Business Unit that works closely with customers to deliver fully validated customer-focused automated solutions. Ian regularly presents training courses and seminars on practical approaches to computer validation.

Tony Rowland
TONY ROWLAND
Partner & Senior Consultant – Melbourne

Tony has over 45 years experience in the pharmaceutical industry, specialising in compliance to FDA GMPs, PIC/S Guide to GMP for Medicinal Products and the manufacture of sterile products. Tony has successfully directed a start up GMP consultancy to be the largest and most successful GMP consulting company in Australia.. He has project managed validation and licencing of GMP facilities and conducted many GMP upgrade programs across Asia Pacific. Tony is a regular industry speaker on Quality Assurance in the region and has assisted in the design and implementation of national public GMP training programs for Pharmaceutical and related industries, including graduate and post-graduate programs for supervisors and managers in Australia and Malaysia. He has assisted major Australian and international companies obtain FDA licencing and Project Managed the design, construction, commissioning and validation of sterile injectable manufacturing facilities.

Principle areas of expertise include: Human Bacterial Vaccine Manufacture, Quality Assurance and Total Quality Management Programs, Manufacturing Systems, Quality Systems and Quality Improvement strategies…Compliance to FDA CGMP regulations, EU and PIC/S GMP Guides, TGA regulations, compliance audits and operational upgrades, validation, plant; water systems.

Tony is also a registered auditor for the Australian Pesticides and Veterinary Manufacturing Authority (APVMA) and in this role, conducts GMP licencing audits on behalf of the Australian Government.

David Spaulding
DAVID SPAULDING
Partner & Training Manager – Melbourne

David has over 30 years’ experience working for companies such as GSK, DBL (now Pfizer), Hydration Pharmaceuticals and now SeerPharma. He has been appointed in various roles such as R&D chemist, Production Manager, Logistics Manager, Sales and Marketing Manager and CEO. In his current role, David oversees SeerPharma’s Training Division, including our collaboration with the University of Technology Sydney, to offer Asia-Pacific’s sole Postgraduate course on Good Manufacturing Practice (GMP). He is also the current President of PDA (Australian Chapter). David holds a Honours Degree in Chemistry from Monash University and a Graduate Diploma in Business Administration from Swinburne University of Technology.

Louise White
LOUISE WHITE
Partner & Senior Consultant – Melbourne

Louise has over 35 years experience in the pharmaceutical industry. This includes 13 years experience in a sterile vaccine manufacturing company, CSL and over 22 years within SeerPharma. While in the industry, Louise held roles in Virology R & D, Bacterial Vaccines Production, Quality Control and Production Planning. One of her key roles in SeerPharma is to design, develop and deliver training and education programs relating to GxP compliance and product quality improvement programs.

As a senior GMP consultant Louise has worked with many biopharmaceutical organisations to design and implement Quality Management Systems to a variety of standards including: TGA, ISO, FDA and European cGMP standards. She has also worked on many major validation projects for both sterile and non-sterile multinational companies.

Louise is a registered auditor for the Australian Pesticides and Veterinary Manufacturing Authority (APVMA) and in this role, conducts GMP licencing audits on behalf of the Australian Government.