Strong Data Is Generated By Strong People
By Joanna Gallant, Joanna Gallant Training Associates
In the event you’ve been living under a rock for the last several months, facility inspection information released by FDA has thrust data integrity into the spotlight. As someone who had responsibility for assuring laboratory data quality in the past, I find the recent spate of issues reported in FDA warning letters and 483s to be extremely disconcerting. Each subsequent revelation becomes more unbelievable. The good news is that steps to ensure data integrity are completely within our control – assuming we will put the time into executing them.
Software Solutions For Future Challenges Of Pharmaceutical Plants
With COMOS, Siemens delivers a comprehensive software solution for the optimal integration of engineering and operation.
FDA And Industry Experts Offer Guidance For DQSA Preparation
It’s been over three months since President Obama signed the Drug Quality and Security Act (DQSA) into law, and some of the industry is still unsure how to proceed with preparation for Title II, which outlines the plan for supply chain security. In a recent discussion with Pharmaceutical Online, Ilisa Bernstein, Pharm.D, JD, Deputy Director of the U.S. FDA Office of Compliance in the Center for Drug Evaluation and Research (CDER), encouraged the industry to familiarize itself with the law and the requirements under it.
Use Of Efficiency Tools In MES And Automation Projects
In this era of high technology, many traditionally cumbersome and time-consuming project tasks can be managed more effectively if they are identified up front and the right engineering tools are developed and employed.
Why Monitoring Cold Chain Data Is Not Enough
In the cold chain logistics industry there’s a huge change happening. Lots of data is being gathered by wirelessly connected data loggers, sensors and monitoring equipment. By Nitin Dahad, Dyzle
PHARMA MANUFACTURING INSIGHTS
Sterilizing Filtration Of Enriched And Pure Gaseous Oxygen Employed In Cell Culture Applications
Modern bioreactor aeration concepts increasingly using oxygen-enriched air or pure oxygen gas to improve cell culture productivity. As with air, these alternate oxygen source gas feeds must be filtersterilized to prevent spoilage of bioreactors by contaminant organisms coming from the incoming and outgoing gas streams. Membrane filters are used to sterilize these gases, and must also be integrity testable to assure process security and meet GMP requirements.
Impact Of Strategic Outsourcing On QA Oversight By Sponsor Companies
Recently, we have been observing a change in the approach to outsourcing — more midsize and large biopharmaceutical companies are shifting to a strategic outsourcing model. Strategic outsourcing generally means assigning work to one or a maximum of two preferred (strategic) partners.
Extracting the Value From Outsourcing By Applying Best Outsourcing Practices
By its very nature, outsourcing can be a double-edged sword. On one hand you could consider outsourcing as an approach to increase your geographic reach, retain organizational flexibility or a smaller footprint, or achieve some other business goal.
Biopharma’s Needs And Focus Of Small Sponsors
In this day and age of preferred service provider relationships and/or functional service providers, small pharmaceutical and biotechnology companies present a unique challenge to service providers vying for their business. The resource constraints (both money and people) and time lines are critical, given a narrow or single product development pipeline, little to no revenue stream, and a hyperfocused management team. While these issues may not be unique to small companies, oftentimes the viability of a project, and possibly the company, may lie within two critical aspects — the people and on-time delivery of the project.
Building Strategic Partnerships With CROs For Businesses Of All Sizes
As strategic partnerships become a greater focus for both sponsors and CROs, there are some concerns that these types of relationships will negatively impact the industry by causing a greater imbalance in an already perceived to be unbalanced playing field. These worries tend to come from, and impact, the smaller players in the market. Smaller clients of big CROs worry their projects will receive significantly less attention than the CROs’ strategic partnerships. Small CROs worry there won’t be a place for them in the industry, because they do not have as broad an offering and are unable to provide support across the entire development cycle.
Medical Device Package Inspection Case Study
Medical device manufacturing is a labor intensive process, requiring operator involvement from manufacturing through final inspection of products.
4 Power-Thinking Strategies Of Centered Leaders
The life sciences world has enjoyed many decades of solid success, manifested in a culture of a fairly stable, predictable environment. Unfortunately, pace and predictability in the industry are changing significantly, challenging also the typical work culture.
PHARMACEUTICAL ONLINE VIDEOS
FlexAct® MF is the first automated system for single-use manifold bag filling in biopharmaceutical processes. The system combines high accuracy and reproducible filling. With its automatically-generated batch record and individual bag label, traceability is secured.
Who Is LoJack SCI?
LoJack is a division of the well-known LoJack. This video highlights benefits of partnering with LoJack SCI such as a 25 year law enforcement partnership, SC-ISAC, the only federally sanctioned source of info on threats to your supply chain and cargo.
LoJack SCI | LoJack's Unique Relationship With Law Enforcement
LoJack SCI hold a unique relationship with Law Enforcement. They've been working with them for over 25 years. All Law Enforment recognizes the LoJack SCI brand as a trustworthy partner. They are also leaders in the industry.
LoJack SCI | Exclusive RF Assisted Solutions
LoJack SCI's event-based comprehensive solutions integrated with the recovery-based beaconing technology create unique proactive protection for your products. This directionally based RF component adds the only technology solution that will generate search warrants due to the accuracy level of RF.
Comprehensive Supply Chain Integrity Solutions
This video highlights its comprehensive supply chain integrity solutions. Event based protocols and notifications, real-time condition of goods reports and layer security with RF Technology.
Advocacy Group Lobbies FDA For Testosterone Warning Label
The consumer advocacy group Public Citizen is lobbying the FDA to add a “black box” warning to all testosterone products.
We are a global market leading provider of an air cargo cold chain transportation concept to pharmaceutical companies and their logistics partners. We are unique and the benchmark for global air cargo cold chain management and logistics solutions.
Norwich Pharma Services
Norwich Clinical Services is a contract research organization that provides Bioanalytical Services, Pharmacovigilance and Clinical Research Programs to the pharmaceutical and biotech industries. We combine comprehensive services, exceptional customer focus, and the highly-respected resources and reputation of Norwich to offer a complete range of Clinical Services.
CAMO Software, Inc.
CAMO Software is a pioneer and trusted market-leader in the field of Multivariate Analysis (MVA) and Design of Experiments (DoE) software. Our solutions are used by companies around the world to analyze data and monitor key processes in R&D, Manufacturing and Quality Control.
Since it was founded in 1976, Ropack has become much more than a remarkable and efficient packaging service provider. Every effort is constantly made to make Ropack an extension of your company, a strategic partner that provides turnkey production services and avant-garde solutions.
The Information Source for the Pharmaceutical Manufacturing Industry
Welcome to Pharmaceutical Online, the premier sourcing site for the pharmaceutical manufacturing industry, find industry information on critical environment, particle sizing, pharma process control, pharma material handling, tablet production, pharma sterilizing, pharma cleaning, pharma filtration, pharma packaging, pharma inspection, & much more. Use our product showcase, and offline search service to expedite your discovery of new products and services. Our goal is to help buyers, like you, identify and select suppliers.
Pharmaceutical Online is part of the Life Science Connect media group. The vision of Life Science Leader and Life Science Connect is to help facilitate connections and foster collaborations in pharmaceutical and medical device development to find ways to get more life-saving and life-improving therapies to market in an efficient manner. Connect, Collaborate, Contribute. Please take a moment to join our community and discover the benefits of your free membership.
Quality & Manufacturing
This 15-Minute Guide describes how unifying, simplifying, and automating the management of controlled documents can create an efficient, flexible, and compliant manufacturing operation.
This 15-Minute Guide describes the documentation challenges presented to pharmaceutical companies that outsource clinical trials to CROs.
Accelerate Regulatory Submission Documentation Creation, Review And Approval
Streamlining the regulatory submission process is essential to getting products to market faster, and many organizations use a document management system to support these activities.
Ross SLIM Powder induction shifts into overdrive. In the SLIM system, solids are combined with the liquid flow at precisely the point where positive mixing takes place. A specially modified rotor/stator generator equipped with Progressive Spiral Porting creates a powerful vacuum and draws the powder directly into the high shear zone, where it is instantly dispersed into the liquid stream.
Inhaler Assembly Höfliger is the right address if you make special demands on your assembly machines. In many cases the task of assembling is linked to other complex process steps.
NP-250 Series Pharmaceutical Tablet Press
The Natoli NP-250 Series pharmaceutical tablet press is a reliable, affordable tablet press designed to compress pharmaceutical, nutritional, veterinary, confectionery, and industrial tablets.
Universal Drum Clamp System
Servolift's Universal Drum Clamping System is the cleanest, strongest and most reliable drum handling system
Rapid Biologic Detection System For Air
Azbil BioVigilant’s IMD-A® 300 and 350 systems revolutionize environmental air monitoring for microbial contamination.
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LIFE SCIENCE WEBINARS
H.R. 3204 Drug Quality And Security Act
After so many years of struggling with how to comply with the California ePedigree requirement, we now need to know how to comply with the new federal requirement, H.R. 3204. This webinar will review DQSA requirements and timelines.
Top Things To Consider When Evaluating Your Vendor’s Security Of Supply Strategies
The biopharmaceutical industry’s increasingly complex global supply chains, often involving single-source supplier arrangements, are made vulnerable by uncertain financial environments and unpredictable natural disasters.
Successfully Managing The Risks And Challenges Of Orphan Drugs
Orphan drugs, while life changing and in many cases life saving for patients, are fraught with challenges for biotech and pharmaceutical manufacturers. These range from locating the patients and their physician caregivers, to making sure the patients can pay for these therapies, to the overcoming the numerous risk points in moving very expensive and in most cases temperature controlled goods to patients all over the globe. This webinar looks at addressing these issues. The experienced speakers will guide you through the salient points and considerations when dealing with these challenges.
03.06.14 -- Ron Guido Offers Advice On Supply Chain Security
03/06/14 Pharmaceutical Online Newsletter
03.04.14 -- Pharmaceutical Online Newsletter
03/04/14 -- Pharmaceutical Online Newsletter
02.27.14 -- Pfizer Faces Regulatory Action From Australian Government
02/27/14 Pharmaceutical Online Newsletter
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