I have extensive knowledge in this area and am considered an expert in this field by many. I present and am published in Risk-Based Quality Management (RBQM) and QbD (Quality by Design). I lead the Avoca Quality Consortium work group on RBQM/QbD and provide public training in this area through Cyntegrity. I also blog extensively in this area. I assist companies with, for example:
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- Reviewing SOPs / templates for existing processes to ensure they are in line with regulator guidance and to suggest improvements based on best practice.
- Mentoring and support for teams/individuals implementing RBQM/QbD.
- Development and use of Quality Tolerance Limits (QTLs) and Key Risk Inidcators (KRIs)
- Bespoke training
If you’d like to find out more, please contact me.