Case Study
Thursday, July 13
02:30 PM - 03:00 PM
Live in Singapore
Less Details
For an operator at the filling line, where everything is happening during an endless day with sterile units, no ventilation, and closed doors, has no iPad or computer at hand. Digital transformation must feel unfriendly in this situation. People are often lost between technology, digitalization and manual operations and sometimes forgotten, even though digital transformation is a huge and substantial change for them. It is not enough anymore to press a green or red button, today, the operator needs to know everything about the production line, starting with the beginning and ending with knowing potential future issues. That said, many times, the vendor also doesn´t know what the user really needs, and the other way around, the user doesn´t know what the vendor can provide to support digital transformation efforts. Thereby, there is a need to get all user requirements correctly and to collaborate and find out which scheme or data really is necessary.
This presentation covers:
Nigel currently leads all compliance and inspection readiness activities for Sanofi's combination products business, based in Normandy, France. Prior to Sanofi Nigel has a 30+ year body of experience in quality and compliance across the industry, including tenures at DHL Life Sciences (helping to set up the life sciences logistics unit), Roche, MSD, AstraZeneca and Norgine amongst others.
Monitor complex set of inputs including current environment, industry trends and emerging regulations in order to anticipate potential risks and the need for changes and influence site and global management directions regarding new or revised strategic initiatives. Analyze results of quality system assessments conducted within the network and align strategic improvements with site and global stakeholders.
Developing people, developing processes, effective best practice compliance, root and branch company reviews, gap assessments, organisational fitness assessments, regulatory strategies and development of growth strategies.
Pharmaceutical: focus on product quality and patient needs to develop pragmatic quality systems based on mitigating risk.