|By PR Newswire||
|March 13, 2014 09:02 AM EDT|
TAMPA, Fla., March 12, 2014 /PRNewswire-USNewswire/ -- ISPE announced today that it will conduct the industry's first Quality Metrics Pilot Program designed to define and operationalize standard metrics reporting to the U.S. Food and Drug Administration (FDA). The year-long program will test a series of leading and lagging indicators that will support an FDA risk-based inspection program in lieu of biennial inspections, as directed by the Food and Drug Administration Safety and Innovation Act (FDASIA).
"ISPE is honored to lead this important initiative, which aligns the perspectives of its extensive global membership network and aids FDA in its strategic goals to ensure a reliable supply of medicines," said Nancy S. Berg, President and CEO of ISPE. "Building on the extensive work conducted by the ISPE Quality Metrics project team and FDA input, this pilot program will provide a practical approach for both industry and regulators to refine metrics selection and definition, and to develop an operational and pragmatic approach to implementation."
Since early 2013, ISPE has been bringing industry and regulators together to identify and define potential metrics by facilitating the first public discussions on quality metrics. From those discussions, ISPE developed a whitepaper that proposed an initial list of quality metrics linked to the six systems inspected by FDA, and recommended a pilot test to refine the set of metrics and definitions, data submission process, and evaluation. FDA recently reviewed ISPE's plans for the pilot program and encouraged the Society's plans.
The pilot will be open to a limited number of sites and product types, e.g., solid orals and sterile, and will represent branded, generic, and over-the-counter products, ensuring statistically meaningful findings. The pilot also will take into account a sampling from large molecule sites to test the feasibility and applicability of data definitions and collection. Companies will be assured of complete data confidentiality. To manage the pilot, ISPE intends to work with a highly-respected global consulting firm that will handle data collection, fact-based research, and analysis. Members of ISPE's PQLI® Team will provide project oversight.
ISPE plans to launch the pilot with open workshops for industry education and input to be held with FDA participation during the 3rd Annual ISPE-FDA CGMP Conference in Baltimore, MD, in early June 2014. Findings of the pilot will be published in the form of papers and educational sessions. Final data and evaluation will be supplied to the FDA and participating companies in aggregate form and will include learnings on feasibility and implementation requirements.
ISPE, the International Society for Pharmaceutical Engineering, is the world's largest not-for-profit association serving its Members through leading scientific, technical and regulatory advancement throughout the pharmaceutical lifecycle. The 20,000 Members of ISPE are building solutions in the development and manufacture of safe and effective pharmaceutical and biologic medicines and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters in Tampa, Florida, USA. Visit www.ISPE.org for more information.
Addteq is one of the top 10 Platinum Atlassian Experts who specialize in DevOps, custom and continuous integration, automation, plugin development, and consulting for midsize and global firms. Addteq firmly believes that automation is essential for successful software releases. Addteq centers its products and services around this fundamentally unique approach to delivering complete software release management solutions. With a combination of Addteq's services and our extensive list of partners,...
Feb. 28, 2017 11:00 AM EST Reads: 1,361
Tintri VM-aware storage is the simplest for virtualized applications and cloud. Organizations including GE, Toyota, United Healthcare, NASA and 6 of the Fortune 15 have said "No to LUNs." With Tintri they manage only virtual machines, in a fraction of the footprint and at far lower cost than conventional storage. Tintri offers the choice of all-flash or hybrid-flash platform, converged or stand-alone structure and any hypervisor. Rather than obsess with storage, leaders focus on the business app...
Feb. 28, 2017 10:45 AM EST Reads: 917
In his General Session at 17th Cloud Expo, Bruce Swann, Senior Product Marketing Manager for Adobe Campaign, explored the key ingredients of cross-channel marketing in a digital world. Learn how the Adobe Marketing Cloud can help marketers embrace opportunities for personalized, relevant and real-time customer engagement across offline (direct mail, point of sale, call center) and digital (email, website, SMS, mobile apps, social networks, connected objects).
Feb. 28, 2017 10:45 AM EST Reads: 317
Why do your mobile transformations need to happen today? Mobile is the strategy that enterprise transformation centers on to drive customer engagement. In his general session at @ThingsExpo, Roger Woods, Director, Mobile Product & Strategy – Adobe Marketing Cloud, covered key IoT and mobile trends that are forcing mobile transformation, key components of a solid mobile strategy and explored how brands are effectively driving mobile change throughout the enterprise.
Feb. 28, 2017 10:45 AM EST Reads: 250
SYS-CON Events announced today that MobiDev, a client-oriented software development company, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place June 6-8, 2017, at the Javits Center in New York City, NY, and the 21st International Cloud Expo®, which will take place October 31-November 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. MobiDev is a software company that develops and delivers turn-key mobile apps, websites, web services, and complex softw...
Feb. 28, 2017 10:45 AM EST Reads: 172
SYS-CON Events announced today that CA Technologies has been named “Platinum Sponsor” of SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY, and the 21st International Cloud Expo®, which will take place October 31-November 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. CA Technologies helps customers succeed in a future where every business – from apparel to energy – is being rewritten by software. From ...
Feb. 28, 2017 10:45 AM EST Reads: 852
All clouds are not equal. To succeed in a DevOps context, organizations should plan to develop/deploy apps across a choice of on-premise and public clouds simultaneously depending on the business needs. This is where the concept of the Lean Cloud comes in - resting on the idea that you often need to relocate your app modules over their life cycles for both innovation and operational efficiency in the cloud. In his session at @DevOpsSummit at19th Cloud Expo, Valentin (Val) Bercovici, CTO of Soli...
Feb. 28, 2017 10:30 AM EST Reads: 1,586
“We're a global managed hosting provider. Our core customer set is a U.S.-based customer that is looking to go global,” explained Adam Rogers, Managing Director at ANEXIA, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Feb. 28, 2017 10:30 AM EST Reads: 2,481
More and more brands have jumped on the IoT bandwagon. We have an excess of wearables – activity trackers, smartwatches, smart glasses and sneakers, and more that track seemingly endless datapoints. However, most consumers have no idea what “IoT” means. Creating more wearables that track data shouldn't be the aim of brands; delivering meaningful, tangible relevance to their users should be. We're in a period in which the IoT pendulum is still swinging. Initially, it swung toward "smart for smart...
Feb. 28, 2017 10:15 AM EST Reads: 289
DevOps is often described as a combination of technology and culture. Without both, DevOps isn't complete. However, applying the culture to outdated technology is a recipe for disaster; as response times grow and connections between teams are delayed by technology, the culture will die. A Nutanix Enterprise Cloud has many benefits that provide the needed base for a true DevOps paradigm. In his general session at 20th Cloud Expo, Chris Brown, a Solutions Marketing Manager at Nutanix, will explore...
Feb. 28, 2017 10:15 AM EST Reads: 1,957
Growth hacking is common for startups to make unheard-of progress in building their business. Career Hacks can help Geek Girls and those who support them (yes, that's you too, Dad!) to excel in this typically male-dominated world. Get ready to learn the facts: Is there a bias against women in the tech / developer communities? Why are women 50% of the workforce, but hold only 24% of the STEM or IT positions? Some beginnings of what to do about it! In her Day 2 Keynote at 17th Cloud Expo, Sandy Ca...
Feb. 28, 2017 10:00 AM EST Reads: 10,377
Tricky charts and visually deceptive graphs often make a case for the impact IT performance has on business. The debate isn't around the obvious; of course, IT performance metrics like website load time influence business metrics such as conversions and revenue. Rather, this presentation will explore various data analysis concepts to understand how, and how not to, assert such correlations. In his session at 20th Cloud Expo, Leo Vasiliou, Director of Web Performance Engineering at Catchpoint Sys...
Feb. 28, 2017 10:00 AM EST Reads: 2,146
SYS-CON Events announced today that Technologic Systems Inc., an embedded systems solutions company, will exhibit at SYS-CON's @ThingsExpo, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Technologic Systems is an embedded systems company with headquarters in Fountain Hills, Arizona. They have been in business for 32 years, helping more than 8,000 OEM customers and building over a hundred COTS products that have never been discontinued. Technologic Systems’ pr...
Feb. 28, 2017 09:30 AM EST Reads: 188
DevOps is often described as a combination of technology and culture. Without both, DevOps isn't complete. However, applying the culture to outdated technology is a recipe for disaster; as response times grow and connections between teams are delayed by technology, the culture will die. A Nutanix Enterprise Cloud has many benefits that provide the needed base for a true DevOps paradigm.
Feb. 28, 2017 09:30 AM EST Reads: 1,069
The buzz continues for cloud, data analytics and the Internet of Things (IoT) and their collective impact across all industries. But a new conversation is emerging - how do companies use industry disruption and technology enablers to lead in markets undergoing change, uncertainty and ambiguity? Organizations of all sizes need to evolve and transform, often under massive pressure, as industry lines blur and merge and traditional business models are assaulted and turned upside down. In this new da...
Feb. 28, 2017 09:30 AM EST Reads: 1,739