Whether you just need a few hours of advice or a larger engagement, I’d love to hear from you.
Here are some testimonials.
Example consultative engagements:
- Expert consultancy and training on risk assessment and control compliant with ICH E6 R2 section 5.0. Preparing for ICH E6 R3.
- Leading the definition, selection and implementation of Vendor Oversight KPIs and Centralized Monitoring KRIs.
- Training (face-to-face, virtually, or with SCORM-compliant packages) on metrics definition and use, critical thinking, risk assessment & control, and root cause analysis / CAPA and more. More information here.
- Process mapping and process improvement as part of M&A activity – conducted remotely.
- Leading efforts to implement a new eTMF system – while developing and implementing an approach to the people and process aspects too.
- Facilitating process improvement efforts from definition of the problem, measurement, analysis, recommending improvements, change management and developing a control plan. Mapping processes – as-is and to-be – to assist teams in developing their future vision.
Click below for more information on work on: