Logistic Advances In Clinical Trials
By Sam Herbert, COO, World Courier Better local resources around the world and more sophisticated technology are changing the dynamics of logistics services Sam Herbert, chief operating officer, World Courier, a part of AmerisourceBergen Pharmaceutical manufacturers face a multitude of challenges as they work to bring new products to market. Rising R&D costs, difficult recruitment and retention of patient populations for clinical trials, increased competition among manufacturers of all sizes, more stringent scrutiny over medication prices: All of these factors and countless others are driving manufacturers to be m...
Source: Pharmaceutical Online News - May 13, 2016 Category: Pharmaceuticals Source Type: news

CSS Archiving Project With Billions Of Clinical Trial Data Pieces - Infographic
The CSS Archiving Project s a massive undertaking, containing thousands of trials and billions of trial data pieces from 14 locations all over the world. With this project in place, World Courier will be able to take client's trial records and either return them, destroy them or archive them in a long-term storage. (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - May 13, 2016 Category: Pharmaceuticals Source Type: news

Alexanderwerk - Innovations In Roller Compaction
Remote access via smart- phone or tablet allows the user a permanent, mobile and direct access as well as transparent and quick operation of more than one Roller Compactor. (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - May 13, 2016 Category: Pharmaceuticals Source Type: news

Advanced Multivariate Analysis Training Course
CAMO Software has been providing world recognized training courses in MVA for many years and this course on Advanced Multivariate Analysis is a balance of spectroscopic and non-spectroscopic data and also touches on the concept of Data Fusion, an important area of MVA where multiple data sources can be aligned and advanced models developed. (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - May 13, 2016 Category: Pharmaceuticals Source Type: news

Validation Tips For Probe Calibration of Your Continuous Monitoring (CM) System
Roy Chien, Sr. Director of Product Management, Mesa Labs It is recommended that your Continuous Monitoring (CM) system undergoes a “major tuneup” at least once annually. Although there are monthly or quarterly alarm checks and preventive maintenance schedules to complete, an annual probe calibration to an NIST or ISO 17025-traceable standard and a comprehensive system check/validation will ensure the system is in good working order. (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - May 13, 2016 Category: Pharmaceuticals Source Type: news

Validation Of Dry Heat Sterilization Processes
By Zach Sparks, Manager of Validation Services, Mesa Dry Heat Sterilization is a sterilization process that can be used to terminally sterilize health care products, medical devices, equipment, components or bulk active pharmaceutical ingredients by exposing the items to a temperature of ≥ 160°C for a defined time. For heat stable items, such as glassware or stainless steel equipment, a dry heat sterilization cycle can be run at 250°C to remove bacterial endotoxins from the items. This process is also referred to as Depyrogenation. Bacterial endotoxins are fever inducing compounds, or pyrogens, that are r...
Source: Pharmaceutical Online News - May 13, 2016 Category: Pharmaceuticals Source Type: news

How Safety For Pharmaceutical Compounding Is Changing
Exposure to pharmaceuticals in compounding environments can lead to a number of health risks for pharmaceutical employees and patients. These health risks can range from contact with hazardous waste materials, harmful particulates during pressure changes or even transmissible disease. The U.S. Pharmacopoeia (USP) drug standards are used in over 140 countries and are enforceable by the Food and Drug Administration (FDA) in the United States to protect pharmacy staff and reduce the number of transmitted infections. According to IACP statistics there are currently over 30 states that are compliant with USP 797 and new states ...
Source: Pharmaceutical Online News - May 13, 2016 Category: Pharmaceuticals Source Type: news

Choosing A Data Logger: 4 Steps To Becoming A Data Logging PR2O
By Bradley Pickard, DataTrace Product Manager When it comes to choosing a data logger, you have many options and even more factors to consider. How do you know what to look for, and how can you be sure that you are making the right choice? We recommend the following 4 steps, which will help guide you to becoming a PR2O at selecting the data logger that you need: (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - May 13, 2016 Category: Pharmaceuticals Source Type: news

Pelican BioThermal Announces Launch Of New Asia Headquarters In Singapore
Pelican BioThermal, a global leader providing the largest range of innovative temperature-controlled packaging solutions serving the life sciences industry, has announced the opening of its new Asia headquarters in Singapore. (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - May 13, 2016 Category: Pharmaceuticals Source Type: news

4 Key Dynamics Driving Effective Outsourcing Decision-Making for Lab Automation OEMs
Laboratory automation equipment makers need to stay flexible in their outsourcing strategies because their make-versus-buy decision drivers can change over time — a good reason to conduct periodic reviews to validate the continued relevance of their outsourcing decisions. Key consideration behind effective outsourcing decisions: “Know Thyself”  Probably the most famous of the many ancient Greek maxims handed down by the god Apollo is the one carved into the Temple of Delphi more than 2,500 years ago: “Know Thyself.” That’s good advice for today’s OEMs — especially thos...
Source: Pharmaceutical Online News - May 12, 2016 Category: Pharmaceuticals Source Type: news

4 Factors to Consider When Building Complex Production Systems
When machine builders partner with subsystem specialists to simplify and streamline their equipment design, engineering, production, and support, they can save large amounts of time and, in many cases, up to 50 percent of costs — helping to boost profitability and customer satisfaction. Machine builders “own” their customers’ successes When most people think of business ownership, they think about equity ownership. But savvy managers know otherwise: While other stakeholders may not own equity in their businesses, they may well “own” a share in a company’s current and future succe...
Source: Pharmaceutical Online News - May 12, 2016 Category: Pharmaceuticals Source Type: news

NEW FDA Data Integrity Draft Guidance – Key Points to Understand
Date: Tuesday, June 14, 2016 Time:1:00pm-2:30pm, EDT US Duration: 90 Minutes - Online Price: $299 - Includes Bonus Handouts! (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - May 12, 2016 Category: Pharmaceuticals Source Type: news

Do You Understand The Workflow Of Your Cloud-Based ERP System?
This inforgraphic details the workflow of a cloud-based ERP system, including track and trace. (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - May 12, 2016 Category: Pharmaceuticals Source Type: news

5 Ways to Streamline Building Manufacturing Systems for Biotech and Pharmaceutical Industries
Today’s biotech and pharmaceutical production facilities must drive faster times to market and greater profitability for new products by boosting production yields and accelerating commercialization and scaling of capacity. Manufacturing: Strategic tool for biotech and pharmaceutical industries Rising healthcare demand worldwide is driving the need for expanded manufacturing capacity in the biotech and pharmaceutical industries. Aging populations. Soaring rates of chronic lifestyle diseases. Emerging middle-classes in developing nations. Treatment and technology advancements. All of these are factors some analysts ...
Source: Pharmaceutical Online News - May 12, 2016 Category: Pharmaceuticals Source Type: news

Ian Whitehall Named Chief Sales Officer At SP Industries
Bill Downs CEO of SP Industries, Inc. (SP) has announced the appointment of Ian Whitehall as Chief Sales Officer managing and directing all global sales programs for the company’s three divisions, SP Scientific, SP Scienceware and SP Ableware. (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - May 11, 2016 Category: Pharmaceuticals Source Type: news