PDA United Kingdom Chapter

Chapter Officers

• 
  Tracy Moore

  Founder and CEO

  President

  TM Pharma Group Ltd.

  pdaunitedkingdomchapter@pda.org

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  >Tracy has over 33 years of experience in pharmaceutical manufacture, distribution and regulation gained from working within the industry and also for the GMP Inspectorate of the UK medicines regulator (MHRA), where she reached Expert Inspector level/status. 10 years as an MHRA, EU and WHO PQT GMP Inspector. Tracy had responsibility for licensing and inspection of pharmaceutical manufacturers and distributors both in the UK and overseas, the development and implementation of regulations and European guidelines relating to pharmaceutical manufacture and distribution, the management of risk and noncompliance in these sectors and collaboration with other European and International regulatory authorities. Tracy has expertise across most dosage forms, particularly sterile manufactured products produced aseptically, including supporting the drafting of the GMP Annex 1 update and presenting on this topic at PIC/S and other global regulatory events.

• 
  David Keen

  Director Pharmaceutical Microbiology

  President-Elect

  Ecolab Life Sciences

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  David is a pharmaceutical microbiologist who has worked across the pharmaceutical industry including in primary and secondary manufacturing, both sterile and non-sterile dose forms, for FMCG, CMO and clinical trial manufacturing.

  David is experienced in sterility assurance for dose forms ranging from bulk API to small molecule sterile injectables. He is experienced in both terminally sterilized and aseptic processes, non-sterile liquids, topical products, inhalations and more specialist dose forms such as radiopharma, vaccines and highly potents.

  David’s experience includes dealing with regulatory inspections (MHRA, FDA, EMA, TGA etc), internal and external auditing. He works with teams to solve complex microbiological issues such as non-sterile contamination events, sterility test failures, media trial failures, SIP and moist heat failures. He works with technology ranging from high spec closed system isolators utilizing robotic technology to open cleanroom manufacturing in high risk fields such as ‘specials’ (compounding). In his current role David works with customers on devising the most efficient and robust cleanroom disinfection strategy. He also works with customers on their environmental monitoring programs, water systems and regulatory compliance.

• 
  Lisa Ottowell

  Inspection Readiness Director

  Secretary

  GSK

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  Lisa is a quality professional and former MHRA regulator with over 20 years of expertise in biologicals. Based in the UK, Lisa holds a global role at GSK—a company dedicated to preventing and treating disease through specialty medicines, vaccines, and general medicines. She specializes in GMP compliance, regulatory inspections, infectious diseases, and risk management.

• 
  Angela Bell

  General Manager

  Treasurer

  Medical Engineering Technologies

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  General Manager with over 15 years’ experience in the medical device industry, combining strong technical expertise with strategic and people-focused leadership. Background in Aeronautical Engineering, Forensic Science, and Chemistry, with a First-Class Honours degree in Forensic Science and an MSc in Research Chemistry from the University of Kent. Currently leading Medical Engineering Technologies Ltd. in delivering excellence in medical device and combination product testing.