Understanding the Hidden Costs of Weak GMP Documentation and the Return on Investment for Strong GMP Documentation

In your experience, when an organization has invested in proper documentation, what have the results been like?

The results have been tremendous!

We’ve seen organizations move away from poor compliance and low morale toward a quality mindset with excitement for innovation. We’ve opened career paths for promising writers who love challenge and have a desire to help patients through strong GMP documentation. Our clients have demonstrated returns on investment for our projects by lowering documentation-based costs, reducing turnaround times, reducing documentation-based errors, and shortening regulatory filing times. Documentation comes off the critical path for the first time! Lastly, we’ve seen our projects serve as a springboard for further innovation and enhancements.

In a nutshell, our best results have been realized when GMP documentation is embraced as an opportunity and powerful mechanism to help companies advance new therapies for their patients.

To learn more about GMP documentation, check out the ebook by Bulletproof below! 

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CRYSTALOMICS: A PATHWAY FORWARD FOR PROTEIN CRYSTALLIZATION

Protein-based therapeutics, specifically monoclonal antibodies (mAbs), have become the focus of pharmaceutical R&D over the last decade. While these biologics offer many possibilities when it comes to treating a variety of diseases, they also present considerable challenges during development.

All of these factors combined make manufacturing and delivery of protein-based therapeutics very difficult. If these drugs could be produced at lower viscosities, then a lower volume could be used, making subcutaneous delivery possible; this would also significantly reduce the risk of aggregates. Now, a treatment that typically requires an hour in a clinic could potentially become a simple injection at home.

This informative white paper by Althea covers the challenges of crystallization of proteins for therapeutic use and how to preserve efficiency during crystallization.

Learn more about a pathway forward for protein crystallization in the white paper below! 

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Managing Your Cold Supply Chain to Ensure Your Vaccinations Get to Where They’re Needed Most

World Courier is transporting Zika diagnostic test kits to and from South America.

Companies trust us to transport and store time- and temperature-sensitive products, and the urgent and sensitive Zika diagnostic test kits are no exception! In the midst of concerns, especially for the well-being of athletes, World Courier’s capability and expertise are another reason to have peace of mind.

The Zika virus was a huge fear for the 2016 Olympic summer games in Rio de Janeiro, Brazil. In the white paper below, World Courrier explains the process and challenges of transporting Zika tests for the 2016 Olympic games to ensure the safety of the Olympic athletes and those attending.

Take a look at the full white paper below!

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Tomorrow’s Medicine: Curing One Patient at a Time

You know that tomorrow’s medicine is personalized. With more than 8,100 active cell therapy studies and 1,300 active gene therapy studies underway now, you’re changing the way patients will be treated.

To achieve the best clinical outcomes, the living cells and biological samples you develop or treat must be transported to patients on time and under the most rigorous product and stability specification. Anything less than perfect is unacceptable.

The World Courier eBook below highlights the logistics challenges of gene and cell therapies. Download the full eBook below for more information! 

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American Supply Chain Summit 2017

The American Supply Chain Summit is a leadership focused meeting designed around improving supply chain and procurement strategy across the globe.

The Supply Chain Summit serves as an annual platform to exchange ideas and collaborate on the impact of market dynamics and new technologies for current and future supply chain & operations leaders. This year’s Summit creates an opportunity to examine key case studies on how workforce management, advanced analytics, process improvement, and automation are being rolled out in the world’s best facilities. Join the in-depth discussions on achieving innovation, maximizing supply chain profitability, and increasing visibility and flexibility to mitigate risk.

KEY THEMES


PROFITABILITY & RISK MANAGEMENT

  • Going beyond cost reduction and control to enable profitable growth
  • Building a flexible supply chain to deal with uncertainty
  • Managing for customer service while balancing risk and cost
  • Managing Risk in a Global Market

COST OPTIMIZATION

  • Tools and Logistics processes engineered for greater efficiency
  • Taming complex supply chains to reduce costs without increasing risk
  • Supplier Management that drives “should cost” mentality
  • Cost Reduction through Network Optimization

TECHNOLOGY

  • Disruptive technologies that are changing the supply chain environment
  • The impact of additive manufacturing
  • The Agile Supply Chain as a source of competitive advantage
  • Understanding how IoT will interact and change the Supply Chain

WORKFORCE MANAGEMENT

  • Designing programs that produce desired attraction, development & retention outcomes
  • Talent Management as a driver to reduce labor costs
  • Identifying top performers and building the talent pipeline
  • Building a Culture of Continuous Improvement

Don’t Miss Out — Register Today!  

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Executive Interviews and Visioning: Launching the Business Case for Change

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Performance Behavior: the Lean Methodology for Continuously Improving Performance Behavior

The book ‘Performance Behavior’ (by Neil Webers) describes how an organization can link performance to behavior to minimize waste and optimize performance behavior.

8 FORMS OF HUMAN-WASTE  are outlined which obstruct continuous improvement:

Leadership-waste the result from too much push-management (based on authority)
Comfort-waste the result of targets that aren’t enough stretching
Communication-waste the result of misunderstandings that usually originate from meetings
Discipline-waste the result when people are not being held accountable for not adhering to standards
Goal-waste the result of employees having no idea of what is expected of them
Engagement-waste the result of asking people to take responsibility for events or results which they cannot influence themselves
Solving-waste the waste of capacity to solve problems when people work on solving problems without focusing on the root-cause of a problem
Tuning-waste is the waste where people talk about different problems or solutions

Find out more below!

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Infographic: Fact-Based Negotiation to Get the Best Price on Purchased Components

Conducting fact-based negotiations is an effective cost reduction strategy when sourcing components. The infographic below explains how to leverage a product cost management (PCM) platform to conduct more effective fact-based negotiations.

Check out the full infographic below!

aPriori’s product costing software generates detailed cost estimates and connects all members of your product team to relevant views of cost data – from sales to supplier, from concept to customer.

Hear more from aPriori by joining the discussion at the American Aerospace & Defense Summit on December 6-7 in Scottsdale, Arizona.

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NEWS RELEASE: GKN to form new joint venture to produce titanium powder for additive manufacturing

GKN Hoeganaes has agreed to enter into a joint venture agreement with TLS Technik to manufacture titanium powders in North America for Additive Manufacturing (AM) applications.

Find out more about this venture below! 

Technology & Innovation

Case Study Video: Honeywell Aerospace Boosts Savings with Early Visibility to Product Cost

Early visibility to product cost drivers helps companies eliminate problems before they become extremely expensive to fix.

This was the conclusion of the team at Honeywell Aerospace after their first few programs where they integrated a product cost management platform into the product development process.

Watch the following video case study below to hear Bret Armstrong, Manager of the Should Cost team in Cost Performance Engineering at Honeywell, highlight three specific examples that underscore the value of early visibility to cost for everyone in the product value chain from beginning to end.

Read the full article from aPriori here, and watch the video case study below!