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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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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Optimizing Temperature Control for Biopharmaceuticals

This article first appeared in BioPharm International, October 1, Caroline Hroncich

Today pharma companies are faced with an ever-changing market that includes increased regulatory challenges, globalization, and heightened competition (1). Biopharma companies are rapidly expanding into emerging markets where there are new opportunities for drug development. Conversely, logistics companies must keep up with the demand, ensuring all storage technology is equipped to retain the safety and efficacy of a drug by the time it reaches the end of its journey.

This article by World Courier delves into these relevant industry topics:

  • Common considerations for shipping biopharmaceuticals;
  • Temperature management in extreme climates;
  • Recent advancements; and
  • Looking ahead.

Learn more about optimizing temperature control for biopharmaceuticals in the article below!  

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The Serialization Challenge

Successful serialization strategies require a global approach and considerations regarding installation and aggregation capabilities, traceability optimization and adherence to varying regional regulations. In order to better understand the serialization challenges and opportunities that pharmaceutical companies face, we sat down with the specialists from Clarkston Consulting to gather their insights.

The eBook explores and explains:

  • The Current Regulatory Landscape
  • The Serialization Challenge
  • Best Practices in Serialization
  • Operationalizing a Serialization Program

Check out the eBook below!

clarkston-covereBook, The Serialization Challenge

To hear insights on Manufacturing Excellence, CMO Strategies, Capacity Management, Quality and Compliance, join Clarkston Consulting at the American Biomanufacturing Summit taking place in San Diego next week!

 

 

Managing A Cold Supply Chain

In the build up to the American Biomanufacturing Summit, we sat down with James Klingelhoefer, Regional Sales Director at World Courier to discuss strategies to best manage a cold supply chain. In the article below, James discusses the challenges and opportunities in managing a cold supply chain, explains the most important elements to manage and provides advice to biomanufacturers who may be struggling with their cold supply chain management.
world-courier-infogracphicManaging a Cold Supply Chain

To hear more biomanufacturing insights, join the discussion on May 10 – 11, 2016 in San Diego, CA.

Video: Christopher Murphy’s Experience At The American Biomanufacturing Summit

At the American Biomanufacturing Summit last May we had the opportunity to sit down with one of our key speakers, Christopher Murphy, VP, Operations at Genzyme to hear his thoughts on participating as a speaker and on the summit as a whole.

The American Biomanufacturing Summit is returning to the Hyatt Regency La Jolla in San Diego on May 10th – 11th, 2016.  To find out more about the two day summit taking place next month, visit: www.biomanamerica.com

eBook: Q&A with Brandon Varnau, Vice President and Head of Operations Quality, Sanofi Specialty Care

Our next eBook features industry insights and forecasts from Brandon Varnau, Vice President and Head of Operations Quality at Sanofi Speciality Care, one of the key speakers at the American Biomanufacturing Summit 2016. We asked Brandon:

  • How biomanufacturing in the U.S. differs from international operations?
  • What are the biggest challenges biomanufacturers currently face?
  • How can these challenges be overcome?
  • What is the biggest opportunity in biomanufacturing?
  • What do you foresee as the ‘next big trend’ to influence biomanufacturing?
  • What major changes to you forecast the industry undergoing over the next 5-10 years?

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Brandon joins the speaker line up in San Diego this May to discuss strategies to Create a Quality Compliance Culture Within Biomanufacturing Facilities:

  • Aligning manufacturing and quality objectives to ensure compliance
  • Developing clear compliance expectations for all staff
  • Empowering staff to proactively engage in a culture of compliance
  • Examining various channels and knowledge sharing platforms to communicate compliance practices

Find out more about the sessions, case studies and key themes to be addressed at the American Biomanufacturing Summit 2016!

Achieving Operational Excellence in Biomanufacturing

Operational excellence is a key area of focus at the American Biomanufacturing Summit taking place on May 10-11 in San Diego. With the event less than 8 weeks away we decided to sit down with Seth Davies and Shane Yount the Managing Director and Principal at Competitive Solutions Inc. to hear their opinions on the challenges and opportunities available to biomanufacturers implementing operational excellence programs. We asked:

  • What are the main obstacles that hamper decision-making, internal communication, and accountability?

  • What are some of the options biomanufacturers have when trying to overcome these obstacles?

  • What factors play an important role in achieving operational excellence?

  • What role does employee engagement play in developing and maintaining a sustainable governance model?

  • How can manufacturers assess the current level of employee engagement?

  • What are some best practices that biomanufacturers can adopt to help them achieve progressive and sustainable governance?

  • How can adopting a Process Based Leadership model help drive operational excellence and sustainable governance?

cover1eBook, Operational Excellence

Explore strategies to streamline processes and achieve operational excellence at the American Biomanufacturing Summit 2016.

What to expect from the American Biomanufacturing Summit

We were thrilled that Robert Sparadoski, Associate Vice President, Quality Assurance at Ferring Pharmaceuticals could join us as a Chair at the American Biomanufacturing Summit 2015.  We caught up with Robert to gather his opinions of the event as a whole.

The American Biomanufacturing Summit is returning to San Diego in May 2016. Find out more about the 2016 Summit!

2016 Life Sciences Outlook

There are many changes on the horizon for the life sciences industry. To help pharmaceutical manufacturers navigate the changes ahead Clarkston Consulting has generated the report below to highlight some of the trends and changes that will have the greatest impact on the industry at large. Clarkston Consulting is a leading management, operations & implementation consultancy firm that specializes in the life sciences industry.

The report outlines the current state of the industry by looking at the regulatory environment, changes brought on by mergers, acquisitions, and divestitures, serialization challenges and the state of high value biologics, specialty and orphan drugs.  The whitepaper then examines factors that will have the greatest impact on the industry in the years to come and provides insights on how the industry will be able to successfully respond.

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Explore strategies to overcome the challenges and take advantage of the opportunities in internal manufacturing, external manufacturing, operational excellence, quality management and compliance at the American Biomanufacturing Summit 2016!