Pharmaceutical Technology Whitepaper Alert:
Having trouble viewing this e-mail? Click here. |
You are subscribed to %%list.name%% as %%emailaddr%%.
Click here to unsubscribe or edit your member profile |
|
 |
|
Featured Whitepaper: Surety LLC
Podcast: Don’t Risk Losing “Ownership” of Your Research IP as You Move to an Electronic R&D Environment
Sponsored By: Surety, LLC
As more laboratories and R&D-dependent bio-pharma and life sciences organizations move to electronic workflows in their lab environments, the need to protect Scientific Intellectual Property (trade secrets, formulas, ideas and collaboration) is paramount. But if you aren’t protecting the integrity of your research data in your lab management workflows, you risk losing ownership, revenue and potentially your business if you can't prove time of creation (“first-to-invent”) and authenticity. Surety hosted a podcast series with Michael Elliot of Atrium Research & Consulting and Timothy Carroll, Partner at Loeb & Loeb, LLP, discussing important topics that can improve your organization's IP data security and integrity.
The podcast series includes discussions on:
The podcast series includes discussions on:
• The benefits of an electronic R&D environment
• Across-the-board, data-level security controls that must be in place to protect Scientific Intellectual Property (IP) as the” lifeblood” of the organization
• How digital timestamp technology can act as “trusted witness” to protect the integrity and legally defend the authenticity and ownership of IP.
Listen in to this three-part series to gain valuable insights into effective and affordable IP protection for your electronic lab environment.
|
|
| |
|
| |
 |
|
| |
Low-Cost Equipment Sourcing... Are You Being Left Behind?
Sponsored By: EquipNet Inc
In order to drive down costs, leading manufacturers are turning to low-cost sourcing when upgrading their capital equipment. A growing share of companies' equipment supply now comes from overseas suppliers, the second-hand market, and redeployment of the company's own surplus assets. |
| |
Nano-Scale Compounding via Hot Melt Extrusion (HME)
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 API’s/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. |
| |
Satisfying GMP with Handheld Near-Infrared Analyzers in the Pharmaceutical Industry
Author: Suzanne Schreyer
Sponsored By: Thermo Scientific
Pharmaceutical manufacturing is a highly regulated industry and manufacturers of excipients, actives and finished products must conform to good manufacturing practices (GMP). Handheld near-infrared analyzers can significantly enhance workflow and productivity, while meeting necessary regulatory requirements. |
| |
|
 |
|
|
 |
|
| |
Risk Evaluation and Mitigations Strategies and the FDAAA
Authors: Debra Norman, Ph.D., JD & Gary Hindman, Ph.D.
Sponsored By: Beckloff Associates, Inc.
On March 25, 2008, new legislation designated as the Food and Drug Administration Amendments Act of 2007 (FDAAA; “the Act”) took effect, which directed FDA to develop a systematic, scientifically sound approach to managing the risk-benefit ratio of a drug throughout its lifecycle, with an explicit focus on postapproval safety. In September 2009, FDA announced a draft guidance to assist sponsors in the preparation of a REMS. The guidance provides links to a number of resources available at FDA to aid in REMS preparation. |
| |
Procedure for Determining an Acceptable Daily Exposure under Risk-MaPP
Authors: Allan W. Ader, Robert G. Sussman, Tracy A. Kimmel, and Robert H. Ku
Sponsored By: SafeBridge Consultants, Inc.
From a product safety perspective, multi-purpose pharmaceutical and chemical plant manufacturing operations need to be able to adequately clean product contact surfaces, in order to prevent contamination from one product to the next. Contaminants may include active pharmaceutical ingredients (“APIs”), cleaning agents, decomposition products, synthetic intermediates, excipients, or other residues. Previous approaches in the pharmaceutical and biotechnology industries have been to establish safe or acceptable limits based on a percentage of the human therapeutic dose or of the lethal dose in laboratory animals. More scientifically supportable health-based risk assessment approaches have recently been issued by the International Society for Pharmaceutical Engineering (“ISPE”) under their Baseline Guide® Risk-Based Manufacture of Pharmaceutical Products (“Risk-MaPP”). The following paper describes the procedure employed to establish an Acceptable Daily Exposure (“ADE”) and the scientific rigor needed to establish defensible ADE values. |
| |
Quality, Operational Excellence and Continual Improvement in the Pharmaceutical/Biotechnology Industry: 2010 Report card.
Author: Mr Neil Wilkinson
Sponsored By: NSF-DBA (USA) LLC
The Pharmaceutical/Biotechnology industry has lagged behind other industries in its approach to quality, Operational Excellence & Continual Improvement. Find out what the industry is doing to make change. |
| |
|
 |
|
| |
A Rapid Approach to the Confirmation of Drug Metabolites in Preclinical and Clinical Bioanalysis Studies
Author: Robert S. Plumb
Sponsored By: Waters
The Waters Xevo TQ MS combined with the ACQUITY UPLC System enables rapid and high-quality collection of both quantitative multiple reaction monitoring and qualitative full-scan MS/MS data without the need for long analysis times or repeat injections. |
| |
Pharmaceutical Continuous Monitoring Methods Comparisons
Author: Ken Appel
Sponsored By: Veriteq, a Vaisala company
Six different wired, wireless and standalone instruments for continuous monitoring are systematically compared in terms of lifetime costs and risks of non-compliance in the context of today’s regulatory environment.
|
|
|
| |
Using Photostability Chambers to Meet Requirements of ICH, Q1B
Author: Bob Dotterer
Sponsored By: Caron Products & Services, Inc.
For companies performing photostability testing in accordance with ICH Guidelines, Q1B, Caron’s 6540 series chambers overcome the challenges of lamp selection, light control and other chamber design issues. By integrating technical requirements with practical solutions, Caron’s Photostability Chambers enhance the testing process to ensure product quality and regulatory compliance.
|
| |
|
 |
|
|
|
|
 |
|
| |
New Ways to Maximize the Business Impact of Quality Management Solutions
Sponsored By: Sparta Systems
As regulators increase their focus on the pharmaceutical quality system, managers can begin to apply quality management as a long-term strategic investment. In this technical paper, Forrester Consulting explores the results of recent market research on how quality management systems, and supportive software, can help to achieve crucial manufacturing and operational goals (e.g., containing costs, promoting efficiency) at the global level. |
|
|
|
|
|
 |
|
|
Analysis of stickpack packaging
Author: Paul Dupont
Sponsored By: Ropack
This whitepaper considers the benefits of stickpack to consumers and to pharmaceutical and nutraceutical firms. It also outlines the unique manufacturing requirements and what equipment features are critical to consider. |
| |
|
|
 |
| |
|
| |
Cleanroom Equipment, Garments & Accessories |
| |
|
|
|
Donning by Design
Author: Damon Larkin
Sponsored By: KIMBERLY-CLARK PROFESSIONAL*, KIMTECH* Brand
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. |
| |
|
|
| |
|
|
|
|
|
You are subscribed to %%list.name%% as %%emailaddr%%. Click here to unsubscribe or edit your member profile.
To ensure delivery to your Inbox, please add %%email.list%% to your address book. If you need help doing this, click here.
Advanstar Communications provides certain customer contact data (such as customers' names, addresses, phone numbers and e-mail addresses) to third parties who wish to promote relevant products, services and other opportunities which may be of interest to you. If you do not want Advanstar Communications to make your contact information available to third parties for marketing purposes, simply call (toll free) 1-866-529-2922 at any time, or fax us at 1-218-740-6417. Outside the U.S., please phone 1-218-740-6395. Contact us by mail at Advanstar Communications Inc., 131 West First St., Duluth, MN 55802-2065, USA.
|
|
|
