Human Performance in Pharma Manufacturing

Successes and challenges to meaningful industry change in pharmaceutical and biopharmaceutical manufacturing.

About the event

Adopting the principles and practices of human performance has led to valuable business and safety performance improvements in high-risk high-consequence industry sectors, such as energy and aviation. Eager to realise similar levels of improvement, several companies in the pharmaceutical and biopharmaceutical manufacturing sector have begun the adoption of human performance within their operations. However, the unique industry context and regulatory environment of this sector has proven the adoption of human performance principles and practices to be more challenging and complex than simply copying from the successes of other industries.

In this webinar, you’ll hear from industry professionals who will share their experiences and perspectives on human performance adoption value, successes and challenges.

Topics and presenters


  • Dr Brian Edwards trained at Guy’s Hospital, London in hospital medicine and clinical research. He has worked for the Medicines Control Agency, Parexel and Johnson & Johnson, there as a deputy qualified person for pharmacovigilance. For the last 13 years, he was Principal Consultant in Pharmacovigilance at NDA Regulatory Science based in the UK. Brian is Director of ISoP Secretariat Ltd and co-chairs the ISOP Medication Error Special Interest Group, Vice President Pharmacovigilance & Drug Safety in the Alliance Clinical Research Excellence and Safety (ACRES) and Chair of the UK Pharmaceutical Human Factors Group. He has recently been awarded a Fellowship with the International Society of Pharmacovigilance. Currently he consults for his own company, Husoteria Ltd.
  • Julie Avery is former Global Lead for human factors at GSK, with over 20 years in Quality and Operational Excellence. As an independent practitioner, Julie now integrates human performance into existing systems strategically and tactically supporting business goals and KPIs. Julie leads the CIEHF Human Factors Pharmaceutical Manufacturing COP and is a Trustee of the CIEHF representing Associate Members.

Topic 1: Why we focus on human performance

  • James Morris, executive director at NSF Health Sciences, has over 30 years’ pharmaceutical operations experience in quality and manufacturing; He’s often leading consulting and training projects in investigation and CAPA management.

Topic 2: How human performance reflects a way of thinking – beliefs and principles

  • Amy Wilson has more than 20 years’ experience in biopharma manufacturing, focusing on human and organisational performance, operational excellence, risk management and technical training.
  • John C Wilkes is Human Performance lead for biologics at AstraZeneca. He has more than 25 years’ experience in industry, in manufacturing operations, operational excellence, quality systems and quality control.

Topic 3: In terms of internal challenges, how can we get out of our own way?

  • Clifford Berry is head of business excellence for Takeda at its Massachusetts Biologics Operations site. He’s been a human and organisational performance practitioner for over 20 years, with experience in commercial nuclear electrical generation, electric transmission and distribution, and biopharma.