Bruce Davis

Bruce Davis runs his own training/consultancy company for science and risk based approaches to Engineering and Process Validation (PV), Quality by Design (QbD), Technology Transfer (TT), Quality Risk Management and other related topics. He has run many training events for companies both in the UK and internationally. He is past Chair of ISPE International Board of Directors. He led, co-lead or contributed to a number of their guidances for PV, QbD & TT and most recently has co-written one chapter on TT for ATMPs (i.e personalised medicines) . He is a professional engineer with many years’ experience in the pharmaceutical industry and a wide international knowledge. He previously worked at AstraZeneca, where his responsibilities included managing international engineering and leading changes to qualification practices. He is an established trainer and likes to engage with participants, to try to ensure the training experience is related to their particular requirements, and to bring in the importance of science and risk based thinking.

  • Next: 1 May 2024 Live online
  • Also: 25 Sep 2024 Live online

ICH Q9(R1) Quality Risk Management (QRM)

New for 2024

Live online

ICH Q9(R1) Quality Risk Management has recently been updated by the regulators. This training course will bring participants right up-to-date with the latest Q9(R1) requirements. It will explain the changes and give context as to how these impact pharmaceutical products and processes. It will cover a range of product types and situations.

  • Presented by Bruce Davis
  • Next: 21-22 May 2024 Live online
  • Also: 23-24 Sep 2024 Classroom

Process Validation with Qualification

Live online, Classroom

Gain a comprehensive understanding of the EU and FDA process validation guidance, learn how to establish a process validation programme, understand the link between QbD and process validation, apply relevant tools for process validation including risk assessment.

  • 12 CPD hours Focused
  • Presented by Bruce Davis
  • Next: 16-17 Jul 2024 Live online
  • Also: 7-8 Oct 2024 Classroom

Effective Technology Transfer

Live online, Classroom

The ‘how to’ of technology transfer across the product lifecycle

  • 12 CPD hours Focused
  • Presented by Bruce Davis