



The Purpose of the Learning
is identified for each of the participants
- How knowledge will be used on the job
- Metrics on performance that will improve
Example: Training Events
Value-Add is Agreed in Advance
Adds transparency & aligns expectations
Allows “performance based” contracts
Shared goals for a long-term relationship
- Strengthens trust and communication
- Puts performance in focus
Employee Engagement: *Problems discovered early
*Morale positively impacted *Staff retention
Fewer FTEs on Inspection & Preparation Time
Lower CapEx and Risk with Standardization
Better Process Control
* Less rework * Less inventory * No stock outs
Shorter Predictable Downtimes
* Improved capacity * Less corrective maintenance
Daily Management System:
* Standard work * Area readiness
Biologics DSP Technical Expertise:
* Troubleshooting & Training
* Cleaning/Sanitation
* Process design, economy & scale up
Validation Strategies:
* Prospective or remediation
Value
Services
Value
Quality Objectives Linked to Business Objectives
Lower FTE Costs via Improved Productivity
Measurable Efficiency & Effectiveness
Backlogs Sustainably Reduced
Cost of Non Quality Reduced/Identified
Services
Process & Value Stream Mapping
Continuous Improvement Integration
Problem Solving Skills Support (CAPA)
Risk Based Handling of Deviations/NCs
“SOP” Simplification & Standardization
Training: Risk Based Tools & Thinking
Risk Assessment Facilitation
Design/Review QRM Approaches
Project Quality Management
"Reverse" QbD for On-Market Products
Value
Known Risk Profile at Hand-offs
*Better tech transfer *A fair price for IP
Cheaper Faster Development:
*Less rework * Predictability * Clear Priorities
Control Strategy Linked to CQAs
*Faster CAPA & QP Release *Up to date files
Services
Slide Images Above for Info on Services
Testimonials
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He is dedicated and is always ready to serve and understand the needs and requests from the customer.
I can fully recommend him.
He is very professional & conscientious. He brings a lot pleasure and dynamism to his work and was great to work with. He worked very closely with the affiliates ensuring proper QM in their logistics facilities, and, clearly knew the NN QMS very well indeed. Whilst we worked together he always strived to keep things as simple and practical as possible something I appreciated at lot. It was a pleasure to work as a team together with Irwin.
“Working with Irwin was a real pleasure”
Irwin is a highly motivated, diligent and committed person in carrying out his responsibilities. His sound knowledge and experience for implementation of Quality by Design principles for biophamaceauticals manufacturing, combined with excellent presentation skills made the subject matter easier to grasp. As a person, Irwin is very sociable and always eager to help out.
I would recommend Irwin for a professional appointment as he would be a valuable resource in any organization that needs dependable people.