Operational readiness from design and validation to FDA audits.
Do your business functions let you can create sustainable manufacturing capabilities FAST?
Read our whitepaper on the challenges of GMP product commercialization from a manufacturing perspective
Are you at risk for a 483?
A GMP commercialization project is an information risk and people management challenge.
The fallout with manufacturing related deficiencies can impact safety, efficacy, pharmacology, labeling, non-clinical studies, can take months to even years to resolve.
It can be challenging to:
Develop an in-depth process/product knowledge during development can mean additional investment during early stages of the project.
Transfer process/product knowledge because functional groups responsible for development are usually different than those responsible for manufacturing.
How do you handle enlisting another department to perform work for your projects?
How do you build seamless collaboration across functional groups, with a common outcome, to deliver quality products to patients FASTER...for a LIFETIME?
You can spend all week in meetings devising create a clear path forward where all stakeholders agree.
In a perfect world, communication is seamless, everyone knows exactly what they're doing and patients come first.
But in the real world...
Organizations are divided into functional groups within a hierarchical lane structure.
A Modern organizational structure is great for performing discrete tasks but struggle when a large cross-functional effort is required.
This can create operative islands within an organization.
These operative islands can be hazardous to a project which can create risk to scope, schedule and budget.
When commercializing and manufacturing therapeutic products you need management systems to handle this challenge.
Then again you could always look for the simplest tools to GMP compliance
Problem is the simplest answer isn't really all that simple.
You have the tools, but how do you get the people to use them?
A lot of project management tools are… tools.
They're not a system.
The big elephant in the room is aligning the systems so they work right, the first time.
All the tools and analytics mean nothing if you can’t move the project to the next phase.
CAI's FSO sees the obvious problem – lack of control in improving capabilities and product outcomes
Designing, constructing, validating and maintaining a GMP manufacturing facility is a complex process involving many stakeholders interacting across functional and managerial boundaries to create, share and develop information.
FSO means "big picture" thinking
CAI's FSO collaborates with stakeholders so people understand and use a tool so tool effectively.
The ability to change between product types, scale-up/down/out, change volume output, make products, process, facility, staff changes, rapid deployment, multi-phase capability.
Flexibility with respect to time, able to speed up and slow down when necessary.
Consistently creating outcomes as expected.
The total cost of delivering goods, fixed and variable costs. Cost of goods, etc.
The quality associated with product manufacturing. How much rework is required? How many defects are produced in end products?
The time required to complete the entire manufacturing process and associated work/value streams.
FSO concentrates on operational requirements…so you can stay focused on patient needs
FSO lets you:
- Access real-world data across your system
- Build an agile manufacturing organization
- Reduce costs and lead times
- Bring product to market faster…
Which means you are better serving product demands.
CAI lifts your burden because we SEE the bigger picture
We deliver high performance teams to help our customers meet a higher standard to bring life changing products and new technologies to global markets.
CAI's FSO system results in delivering life-enhancing products faster.
The FSO model applies to life science GMP manufacturing
- Chemical therapeutics
- Biological therapeutics
- Biomedical devices
- As well as Nutraceuticals and Food
Downloading our whitepaper HERE
Imagine removing regulatory uncertainty with an organization that is laser-focused on product quality and patient safety.“CAI partnered with a biologics manufacturing firm by and utilizing an FSO approach during the design, construction, and validation phases of their new $30M retrofitted blood fractionation plant in Singapore. CAI helped developed operating procedures and production records to help reduce operational variability and ensure product quality for first-in-class electrophoresis process optimization/modeling and removed $1M worth of unnecessary equipment.
FSO is the best practice for full-scale commercial GMP manufacturing
The FSO model leverages your organization's product and process knowledge cost-effective design, construction, and qualification of a facility the development of a staff capable of full-scale product manufacturing operations in a GMP regulated industry.“CAI led an integrated project delivery system through accelerated milestones, delivering on time, and within the approved budget. Additionally, CAI helped develop a safety-first culture, reaching almost one (1) million safe man-hours during the start up and commissioning phases of the project.
Think of FSO as your organizational foundation for achieving high performance GMP manufacturing.
When clients tell us they’ve developed a safety-first culture, reaching almost one (1) million safe man-hours during the start up and commissioning phases...
We’re proud to call them partner!
Download our whitepaper to see how you canYes, I want this whitepaper!