Pharmaceutical Technology Whitepaper Alert:
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Featured Whitepaper: Surety LLC
Not all ELN IP Protection Controls are Equal – What You Should Know as You Go Electronic
A Technology Comparative of “Digital Notarization” Solutions
Sponsored By: Surety, LLC
Using an electronic lab notebook (ELN) or planning to move to one? More laboratories and R&D-centric organizations are changing from paper-based to electronic workflows to remain competitive…and why not? From initial conceptualization through product development and production, ELNs and other lab informatics systems are efficient and effective for what they are designed to do.
The problem is, though, they lack certain defensibilities, particularly long-term, independent protection of the integrity and authenticity of your scientific intellectual property. So how can you ensure the safety and your ownership of your IP in a legal or regulatory dispute?
Many R&D organizations have turned to digital signatures and digital timestamping as solutions for IP protection. But not all are equal. You should be aware of the differences.
This new whitepaper from IP Protection Leader, Surety, examines four of the most common digital protection controls for research-based IP, providing a comprehensive “graded” evaluation of each, and painting a portrait of the bioscience community's various options for neutralizing potential patent and other “ownership” litigation.
Get FREE whitepaper now |
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Quality Management Systems Demystified
Author: KR Karu
Sponsored By: Sparta Systems, Inc.
Learn how companies are utilizing best-of-breed ERP, EQMS, and PLM systems to save organizations money while increasing compliance at the same time. |
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Improving Product Quality with Risk Assessment Tools
Author: Brenda Percy
Sponsored By: EtQ, Inc.
With the product lifecycle moving so fast, many organizations may ask the question, “how can we effectively measure quality?” The answer is Risk Management. Learn the elements of Risk Management and how they help to identify, prevent, and mitigate risk throughout an organization. |
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Streamlined Approach for Nasal Spray Product Development & Manufacturing
Author: Charles Shaw
Sponsored By: DPT Laboratories
This whitepaper will provide a comprehensive overview of the CMC guidance by the U.S. Food and Drug Administration and present a streamlined approach for development and manufacture of nasal spray products. |
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Biosimilars: Global Impact of the Biologics Price Competition and Innovation Act of 2009
Sponsored By: Beckloff Associates, Inc.
On March 23, 2010, President Obama signed into law the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), which amends the Public Health Services Act (PHS Act) to create an abbreviated approval pathway for biological products that are shown to be highly similar (i.e., biosimilar) to or interchangeable with an FDA-licensed reference biological product. Biological products are generally derived from living material (e.g., human, animal, or microorganism), have complex structures and are usually not fully characterized. |
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How to Avoid (and Respond to) FDA 483s
Sponsored By: Vaisala
The following article shows excerpts from some common observations in Form 483 Letters. After the excerpts, we outline 10 best practices of a 483 response including links to further resources. Then we discuss different methods of monitoring, alarming and reporting critical parameters like temperature and humidity in FDA-regulated environments and how to avoid deviations from cGMP in your regulated environments. |
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Seven Secrets to a Successful Auction
Sponsored By: EquipNet
Have you been elected to close your facility? Or do you have idle assets in your facility that need clearance? Selecting the right auction partner can be difficult. We created a Better Auctions Resource Center and an eBook, “Seven Secrets to a Successful Auction”, as tools to guide you through this process. |
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New UV Intensity Multiplication Technology dramatically improves protection against Airborne Contamination
Author: Dr. Wayne Clark
Sponsored By: Novatron, Inc.
This paper presents a review of existing air sterilization techniques and describes an innovative new technology that provides levels of air sterilization not previously achievable. The technology provides a breakthrough capability for supplying sterile air for biopharmaceutical manufacturing, clean room, hospital, bio containment and defense applications. |
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ROTRONIC's New Technology Reduces Calibration Time
Author: Greg Gowaski
Sponsored By: Rotronic Instrument Corp.
Maintaining the accuracy of your humidity and temperature instruments requires periodic calibration. Calibration of these instruments can be a costly and time-consuming venture. ROTRONIC’s new AIRCHIP 3000 Digital technology greatly reduces calibration time and cost by eliminating one full calibration cycle. |
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An Introduction to Pharmaceutical Forensics
Author: David Exline
Sponsored By: Gateway Analytical
Pharmaceutical forensics applies forensic expertise, analysis and problem solving principles, and addresses quality issues such as nonconformance and deviation investigations, contaminant identification and source determination. This whitepaper provides an introduction to this approach and a case study example of particulate examination. |
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