BioPharm Excel

Nuala is one of the leading experts on designing and leading performance improvement in the Biopharma industry today. With deep knowledge of the FDA's Quality Metrics Initiative gained both as a leader of the ISPE Quality Metrics Team and as a key member of the St. Gallen University led research team providing research directly to FDA, Nuala has designed this unique course to help your organisation transform its approach to delivering real performance improvement in your organisation.

​

Upon completion of the course, participants will be able to:

• Understand the fundamentals of Performance Improvement Measurement

• Deconstruct existing management oversight dashboards

• Design KPIs that really matter to the business

• Understand the power of Key Behavioural Indicators (KBIs) in your metrics design

• Design KBIs to deliver the results required by the business KPIs

• Enable accountability and ownership through improvement teams and

• Sustain improvement through coaching and mentoring

In the context of the current regulated life science manufacturing environment, a traditional business strategy that focuses on compliance-led processes and procedures is no longer effective in delivering excellence and reducing risks in the global supply of high quality medicinal, medical device and diagnostic products.

 

Upon completion of the course, participants will be able to:

• Understand the fundamental concepts of Cultural Excellence and behaviour based quality

• Distinguish between a compliance-led culture and an excellence-led culture

• Value the power of building learning organisations and learning teams

• Understand the link between Key Behavioural Indicators (KBIs) and Key Performance Indicators (KPIs) in your metrics design

• Enable accountability and ownership through multi-disciplinary improvement teams

• Build sustainable improvement programs through the development of new competencies and capabilities

• Understand the importance of recognising and rewarding wins

Five years on from the UK Medicines and Healthcare products Regulatory Agency (MHRA) notification of intention to inspect for Data Integrity (December 2013), what have we learned from the initial regulatory focus in the Labs and what are we now seeing emerge from the manufacturing facility and 3rd Party/supply chain inspections?

 

Learn how to address some of the top challenges and risks posed by computerised systems used across the Biomanufacturing ecosystem and across the data lifecycle. Topics include:

• Latest regulatory trends and guidance

• Understanding risks with stand-alone vs networked systems

• Effective Access Controls

• Managing Audit Trails

• Controls necessary when migrating data across 3rd party networks

• Embedding Data Integrity into Service Level Agreements

• Hot Spots to avoid

• Impact of cloud based services and

• Importance of culture/behaviours to support Good Data Management right across the organization.