Showing items tagged as Process

  • 2019-bl-thumb-turning-mistakes-into-marvels

    Turning Mistakes Into Marvels on the Manufacturing Floor

    Errors. Oversights. Accidents. Mishaps. Bloopers. Gaffes. Fails. Call them what you will, mistakes on the manufacturing floor are unavoidable. And while they usually carry a negative connotation, sometimes a mistake can make a lasting impact for the better.

    Full story
  • "We're Different!" Overcoming the Challenges of Applying Lean Principles to Knowledge Work

    If you are applying lean management principles to R and D, life science, or other knowledge work processes, you’ve probably heard the "we're different” argument. It usually goes something like this, “You can’t apply lean process improvement techniques to creative work because everything we do varies."

    Full story
  • Ignoring This Overlooked Risk Management Metric Leads You Down The Path To The Dark Side

    Hurricanes. Power outages. Socio - geopolitical upheavals. Train derailment. Road closures. Contamination in a supplier facility. Terrorism, cyber-attack, sabotage or industrial espionage. Labor unrest. Global pandemic. Fires, floods and natural disasters. These incidents are not a work of science fiction and the number of them that can negatively affect the supply chain are real and virtually limitless.

    Full story
  • Accelerate Time-to-Market by Improving Process Validation

    Process validation, a general term for critical disciplines such as risk mitigation/management, quality assurance and change management, is something that far too many life science manufacturers only worry about when a product is just about to go to market. That late in the game, though, it can be hard to produce the required and relevant information that has accumulated during years of product development. In a recent article in PharmTech titled “Reducing the Documentation Burden in Process Validation,” Patricia Santos-Serrao, RAC, of MasterControl explains how regulatory agencies define process validation as it pertains to the collection and evaluation of data from the process design stage all the way through to commercial production.

    Full story
  • Risk Management in Clinical Research: Process and Application

    Recently, two key pieces of guidance were released from Food and Drug Administration (FDA) and European Medicines Agency (EMA) regarding risk based approaches to clinical research. These documents include FDA’s “

    Full story
  • How to Design for Compliance: Tips for Getting (and Keeping) Your New Product on the Market

    Having a great product does not guarantee success. The road from concept initiation to commercial release is a long and arduous one. Success depends upon not only understanding the new product development process, but also the FDA submission process, and the complex interplay between the two. Many companies underestimate the value of a carefully thought-out submission strategy. They focus solely on product development and treat the approval process as an afterthought. Others are so eager to get their product to market, they rush the design and testing processes and end up with a product that’s dogged by costly delays or, worse, unmarketable.

    Full story
  • An Introduction to Metrics Collection and Usage

    Most companies understand that the collection of data can be valuable but often don’t really rationalize what they want to collect.

    Full story
[ { "key": "fid#1", "value": ["GxP Lifeline Blog"] } ]