Improving Process Performance  

Expert support for Biotech & Pharma 

Value Proposition
Value Proposition

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

Process Improvement - Manufacturing

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

Process Performance - Manufacturing

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

Process Improvement - Quality Systems
Process Performance - Quality Systems

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

Quality Risk Management
Quality Risk Management

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

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Testimonials

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Irwin has a great helper personality.
He is dedicated and is always ready to serve and understand the needs and requests from the customer.
Irwin is to me a very skilled and valued expert in Quality by Design. I have enjoyed working with Irwin, and I appreciate both his his good spirit as well as his high technical capability and broad overview.
I can fully recommend him.
Irwin was a contractor working in my MSAT team for nearly 2 years developing L&D digital technologies in support of a rapidly growing team and business. Irwin made a big impression with his passion for knowledge, his expertise and the fun that he brought to the task and the team working with him. Given the resources he will add value and bring a different perspective to your organization using his expertise and skills to make improvements and offer a "different" approach to problem solving.
I worked with Irwin while consulting for Novo Nordisk. I was working overseas in Tianjin, China and he was a great asset to the team as he has a great understanding of the quality mindset and how to implement with our unique project needs. Irwin is highly collaborative and we were able to converse about engineering, quality, and validation in very constructive manner. We finished the project under tight timelines and it was a pleasure working with him
I worked closely with Irwin a few years back when we were investigating the smearing issue on FlexPen® cartons.
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.
I first met Irwin in 2006 when he presented a "Fast Trak" course to my Process Development group. At the time, I was highly impressed with the depth of his knowledge and his warm presentation style. I have since had the pleasure to discuss many an industry challenge with Irwin, who never fails to bring sense, order and fresh ideas to the very complicated issues we face in biopharmaceutical process development and production.
I have worked with Irwin in the Business Accelerator at NNE Pharmaplan for half a year. Irwin has the ability to see business opportunities and uses his entrepreneurial skills to combine them with technical solutions and the right people. Irwin has a strong network within the Life Science industry and an extroverted profile which makes him a fast mover in his field.
“Working with Irwin was a real pleasure”
I came to know Mr. Irwin when he gave me a training on Quality by Design for Biopharmaceuticals manufacturing.
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.