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Featured Whitepaper: Surety LLC
Does Your ELN or Lab System Have the Right IP Protection Controls in Place?
The Change to "First-to-File" Doesn't Eliminate the Need for Protecting Electronic Record Authenticity
Author: Jon Roberts, Ph.D., J.D.
Sponsored By: Surety, LLC
Just because the US patent law changed from “first-to-invent” to “first-inventor-to-file” doesn’t mean you don’t need to establish the authenticity of your critical research data. Now, more than ever, the need for proving your ownership and the authenticity of your digitally-based research records is paramount.
If a competitor, who stole your research, files for a patent BEFORE you do, can you prove YOUR records of invention are original?
The most effective means of ensuring admissible, credible, and authenticated business records is through the use of independent, digital timestamping. It is a data-level security control that enables organizations to unquestionably prove – independent of their people, processes and systems – that their electronic records existed at a specific point in time, have not been altered since, and are rightfully owned by the originating organization.
As your organization considers the impact of the America Invents Act on your patent portfolio, use this paper as a guide to several of the key changes, and where and how you should protect your organization's valuable intellectual property with added data integrity protection.
Get FREE whitepaper now |
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Effective Controlled Substances – Supply Chain Management
Author: Bill Clyde
Sponsored By: DPT Laboratories
At a time when supply chain management has become increasingly complex, managing the unique challenges of the controlled substance supply chain can seem daunting for companies lacking in-house capabilities and resources. |
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The 5 Best Innovations in Quality Management Software
Author: Tim Lozier
Sponsored By: EtQ, Inc.
Seems like the “next best thing” is always coming out. For business systems, this tends to hold true in some instances. Take a look at the top 5 best innovations in Quality Management Software—those features and technologies that have turned the industry on its head, and those features that most organizations should not do without. |
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Case Studies: AccuPRO-ID® vs. VITEK® 2 Compact
Author: Christine Farrance, Ph.D.
Sponsored By: Accugenix, Inc.
Accugenix evaluated the accuracy of microbial identifications reported from the AccuPRO-ID® method to the results reported by the bioMérieux VITEK®2 Compact. The data clearly demonstrated that the AccuPRO-ID® service from Accugenix is significantly more accurate than the VITEK®2, leading to more confidence in the EM information and allowing for more effective microbial trending and tracking in a production facility. |
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AQUEOUS CRITICAL CLEANING: APPLICATIONS IN PHARMACEUTICAL MANUFACTURING
Authors: Malcolm McLaughlin, Theresa Dowds
Sponsored By: Alconox
This Guide to Critical Cleaning places a concise overview of our half-century of experience at your fingertips. From tablet presses to mixing tanks, Alconox detergents handle tough critical cleaning jobs—like removing insoluble coatings residues. The benefits of employing aqueous cleaning in pharmaceutical manufacturing are numerous. |
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Hot Melt Extrusion (HME) - nano-scale compounding developments
Author: Charlie Martin
Sponsored By: Leistritz
Hot melt extrusion is emerging as a preferred manufacturing methodology for dosage forms. The high cost and limited availability of raw materials during the development phase has resulted in the need to process small amounts of APIs/excipients via extrusion to determine process viability. Experimental data is presented on a new twin-screw extrusion device that can process as little as 20 to 100 gram micro-batches, as well as a scale-up path. |
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A Scientific Approach to Good Manufacturing Practices
Author: Chris Phillips
Sponsored By: Albany Molecular Research
Contract manufacturing organizations (CMOs) exist in an environment of continuous improvement and evolving quality standards. By scientifically affirming every decision and by embracing integral approaches to quality, CMOs can reduce regulatory risk and become a leader in developing best practices meeting current Good Manufacturing Practices (cGMPs). |
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A GMP Warehouse Mapping Guide
Sponsored By: Vaisala (Warehouse)
This step-by-step guide describes how to map a warehouse to comply with internationally recognized GMPs—including many that have been published or revised recently. It draws on Vaisala’s extensive experience in environmental and industrial measurement and monitoring throughout over 140 countries. |
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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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Characterizing Lamellar Systems with SAXS
Author: Heiner Santner
Sponsored By: ANTON PAAR USA, Inc.
Lamellar systems are used as drug carriers and exist in biological membranes. Their bilayer structure can be efficiently studied with the SAXS method. |
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Forensics Can Help Identify Particulate Contamination
Author: David Exline
Sponsored By: Gateway Analytical
New forensic techniques and approaches are essential for resolving potential safety issues. This white paper discusses an investigative approach to help companies avoid FDA Form 483s by addressing OOS results and nonconformance issues. |
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New HPC grade for DC
Author: Shinichiro Tsue
Sponsored By: Nisso America
We prepared new Super Fine Powder, Special Low Viscosity grade Hydroxypropyl Cellulose with the purpose of developing a high performance dry binder with high compression formability at low use levels. |
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Donning by Design
Sponsored By: Kimberly Clark
This paper addresses the importance of process protection in cleanrooms via the appropriate cleanroom suit. It provides an overview of the sterile cleanroom apparel category and defines key areas for improvement. It introduces a new concept for sterile cleanroom gowning to help minimize the problems associated with current technologies. |
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