Process Analytical Technology (PAT) Case Studies: Real-World Dos and Don’ts to Eliminate Defects, click here to order.

Brought to you by FDAnews, this management report brings the big-dollar benefits of PAT tools to life with two real-world case studies, both before — and after — drug launch, showing you how:

• PAT Tools Find and Fix Batch Failures to Keep $125 Million-per-Year Drug On-Schedule for Launch: this case study shows how a drug, just before launch, started to experience intermittent batch failures. After several root cause investigations failed to find the problem, PAT tools were used — the problem was solved in a short period of time, keeping the drug on-schedule for launch  
• PAT Tools Eliminate Batch Failures, Boost Bottom Line by $7.4 Million Each Year: this case study shows how a drug, six months after launch, experienced an unexplained shift in a release parameter — causing one out of every three batches to be discarded over the next 24 months. Again, numerous root cause investigations failed to find the problem. After PAT tools were put to use, the out-of-spec results were eliminated, adding $7.4 million per year to the bottom line

Each case study offers you an up-close opportunity to see working examples of step-by-step applications and best practices of PAT.

Remember, 15 in 100 drugs on the production line are defective. Now you can get it right the first time when you put PAT tools to work for you — place your order today.

In addition to the case studies, Process Analytical Technology (PAT) Case Studies: Real-World Dos and Don’ts to Eliminate Defects delivers the details you need to:

• Evaluate your manufacturing facility for any bottom-line and “cost of quality” savings opportunities with PAT and quality by design (QbD)
• Understand the financial benefits of a PAT program — and bring others on board
• Determine which PAT statistical tools to use when analyzing your manufacturing process
• Apply the principles of PAT and QbD using this practical framework for pharmaceutical companies
• Save time — and avoid mistakes — when you know the eight dos and don’ts of a successful PAT program

Plus, you’ll have a valuable reference section that includes two guidances for industry, along with general principles of software validation.

Click here for complete Table of Contents.

Now you don’t have to face the fallout when root cause investigations fail to find your pre-launch and production line problems — prevent, detect and correct defects with PAT — Process Analytical Technology (PAT) Case Studies: Real-World Dos and Don’ts to Eliminate Defects, click here to order.

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Order this exceptional management report today. It could save you millions of dollars by reducing failed batches and offering higher yields. Process Analytical Technology (PAT) Case Studies: Real-World Dos and Don’ts to Eliminate Defects is available for $335, in print or PDF format. Click here to order.