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Planning for a Talented Workforce: Building a Staffing Plan for New or Expanding GMP Facilities
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Planning for a Talented Workforce: Building a Staffing Plan for New or Expanding GMP Facilities

Let’s contrast two very real scenarios: You are responsible for bringing a new GMP facility or line to full-scale production. Your board or shareholders expect...

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The Top 2 Elements of FAT Planning
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The Top 2 Elements of FAT Planning

  Your equipment is ordered.  The schedule is set.  The team travel plans are made. But are you ready to maximize your experience at the...

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2018 ISPE Annual Meeting Speakers
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2018 ISPE Annual Meeting Speakers

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Cloud Computing in a Regulated Environment
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Cloud Computing in a Regulated Environment

How can cloud computing be used in a highly regulated environment? (more…)

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Equipment Reliability and Preserving Functional Requirements
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Equipment Reliability and Preserving Functional Requirements

Pharmaceutical companies make huge investments in equipment, materials, and personnel to develop and manufacture life-saving products. The equipment that makes those products is designed, manufactured,...

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Improving Supply Chain Through Human Performance
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Improving Supply Chain Through Human Performance

In many ways, today's pharma and biotech facilities share the same problem that many of the factories that supported the war effort during World War...

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Does your project team have a common vision and goal?
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Does your project team have a common vision and goal?

Sometimes projects are conducted as a series of disconnected efforts where each team from planning, design, construction, and testing views themselves as separate entities. With...

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AAV Vector Production
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AAV Vector Production

Overview Until about 2016, the majority of vectors used in gene therapy were Adenovirus and Retrovirus vectors.  In recent years, a change toward Lentivirus and...

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Empowering Your Operators to Lead Can Reduce Losses
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Empowering Your Operators to Lead Can Reduce Losses

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Visit us at Table 9 at PDA EU Annual Meeting
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Visit us at Table 9 at PDA EU Annual Meeting

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What is Proactive Commissioning?
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What is Proactive Commissioning?

In Maintenance and Reliability, there are a complete set of tools dedicated to Proactive Maintenance.   (more…)

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