Speakers

Dr.Tim Sandle

Pharmaceutical Microbiologist & Head of Compliance & Quality Risk Management - Bio Products Laboratory & Pharmig Committee Member

Pharmaceutical Microbiologist & Head of Compliance & Quality Risk Management -Bio Products Laboratory & Pharmig Committee MemberTim Sandle is a Pharmaceutical Microbiologist and Head of Compliance & Quality risk Management at Bio Products Laboratory, responsible for setting GxP standards and Quality Risk Management at BPL, in addition to acting as an internal pharmaceutical microbiology consultant. In addition, Tim is a tutor with the University of Manchester School of Pharmacy (lecturing on pharmaceutical microbiology) and with University College London Pharmacy School (training QPs in sterility assurance). Tim has been a committee member of Pharmig since 2002, and he writes regularly on microbiology and pharmaceutical science topics, with over 850 books, book chapters, peer reviewed papers and technical articles to his name.

[ KEYNOTE SPEAKER ]

Laura Guardi

Principal Auditor, Global Quality Assurance –
AstraZeneca & Pharmig Committee Member

Laura has 20 years plus experience in the Pharmaceutical and Biotech industry. She has experience in a range of biological QC techniques, vaccine production, and is an experienced auditor (Lead Auditor for GMP/PQMS and ISO 9001). Laura studied at Manchester University for her BSc(hons) degree in Microbiology, which included an industrial placement with Eli Lilly. On graduating, Laura returned to working in QC laboratories at Eli Lily, followed by Unilever, MedImmune in positions of increasing responsibility. At MedImmune she was responsible for set-up of the new QC Virology laboratories, technology transfer of assays from Development to QC and supervision of the laboratory team. In 2006 Laura joined Novartis Vaccines & Diagnostics (then Chiron Vaccines) as a Corporate and Regulatory Compliance Team Manager. In this role she was responsible for internal compliance, vendor management, and supporting the regulatory inspection process. She was also the site’s subject matter expert for TSE Compliance. Laura joined Ecolab Contamination Control in January 2012. In her role as Global Validation Manager Laura provided technical support to customers, advising on cleaning and disinfection of cleanroom environments. In September 2015 Laura joined AstraZeneca as a member of the World-Wide Audit Group, which is responsible for auditing AstraZeneca sites, their suppliers, and contract manufacturers and test laboratories

[ EXPERT SPEAKERS ]

Rachel Kirkham

AVP, Global Technical Consulting Contamination
Control and Validation, Ecolab & Pharmig Committee Member

Rachel has over 30 years’ experience in contamination control, including The Body Shop International, Tristel, Diversey and Ecolab Life Sciences. Rachel’s wide-scoping experience includes disinfectant product development, technical service and commercialization, CMO quality process development and oversight, cleanroom validation process development and management of expert teams. She has been involved in numerous pharmaceutical contamination control projects and routinely carries out audits, training and coordination of disinfectant studies for pharmaceutical sites. In her current role, Rachel leads a contamination control technical team that provides expert technical support to pharmaceutical manufacturers, technical consulting on cleaning and disinfection

[ EXPERT SPEAKERS ]

Kim Morwood

Managing Director Eurofins/MGS Laboratories &
Pharmig Committee Member

Kim is a graduate microbiologist with over 30 years’ experience in the pharmaceutical industry. She worked for GlaxoSmithKline for 18 years in a variety of roles both in manufacturing and R+D and also worked for 4 years as quality control leader at Sanofi-Aventis Dagenham manufacturing centre. Kim has been a director of MGS laboratories since 1998, and took on the full-time role of technical director in March 2006. She is now Managing Director of Eurofins / MGS Laboratories.

[ EXPERT SPEAKERS ]