Additional Services
Practical solutions that go beyond compliance checklists.
While Document Control, Supplier Management, and Auditing are at the core of what I do, I also support organizations in building stronger systems, preparing for high-stakes inspections, and training the people who make it all work.
1
QMS Development
Lay the foundation for quality that lasts.
Whether you're building from the ground up or restructuring what’s already in place, I help design quality management systems that are practical, scalable, and aligned with your operations. I work closely with cross-functional teams to integrate core quality elements—like document control, CAPAs, supplier oversight, and risk management—into a usable framework that fits your business and meets your standards.
​​
How I Support You:
-
QMS gap assessments and system design
-
Development of SOP frameworks and core documentation
-
Integration with existing tools and workflows
-
Alignment with ISO, cGMP, and FDA expectations
-
Onboarding new teams into established systems
​
2
Training Program Development
Training your team shouldn’t be an afterthought.
I design training content and systems that go beyond check-the-box compliance. Whether you’re onboarding new staff, launching a QMS, or preparing for an inspection, I help teams understand not just what to do—but why it matters. The result: less confusion, fewer mistakes, and stronger audit outcomes.
​
How I Support You:
-
Development of onboarding and SOP-specific training
-
Creation of training matrices and documentation tools
-
Live or recorded training sessions on compliance topics
-
Annual training review workflows
-
Tools to improve retention and accountability
3
Inspection & ISO 9001 Readiness
Don’t just get ready. Be ready.
I support companies preparing for regulatory inspections, client audits, and ISO 9001 certification by creating systems that reflect what’s working—and strengthening what isn’t. Whether you're new to inspections or just want extra confidence, I can help prepare your documentation, coach SMEs, and walk through mock audits to reduce surprises.
How I Support You:
-
Mock audits and readiness assessments
-
Document libraries and inspection prep kits
-
On-site or remote support during audits
-
SME training and communication strategies
-
Actionable remediation plans when gaps are found
