|By PR Newswire||
|January 23, 2014 04:58 PM EST||
TAMPA, Fla., Jan. 23, 2014 /PRNewswire-USNewswire/ -- Thomas Arista, Investigator/National Expert-Biotech, FDA/ORA/ORO/DDFI, and Richard Friedman, Associate Director, Office of Manufacturing & Product Quality, FDA/CDER/OMPQ have been confirmed as keynote speakers at ISPE's 23rd Annual Conference on Barrier Isolation, RABS and Aseptic Processing Technology. Mr. Arista and Mr. Friedman will join honorary chair Charlotte Enghave Fruergaard, PhD, Partner, Global Consulting, NNE Pharmaplan to open the two-day conference highlighting significant issues related to barrier isolation – RABS and aseptic processing technologies and disposables. The event will take place 24 – 25 February 2014 at the Marriott Wardman Park in Washington, D.C. USA.
"Preventing contamination of injectable drugs is critical to patient safety. ISPE is dedicated to advancing industry and regulatory understanding and collaboration on issues related to aseptic drug manufacturing processes through our signature Aseptic Processing Conference," said ISPE President and CEO Nancy Berg. "This year's event builds on the conversations from previous conferences to encompass the most up-to-date industry thinking on technology solutions, best practices and lessons learned in real-world case studies."
In addition to Mr. Arista and Mr. Friedman, the 23rd Annual Conference on Barrier Isolation, RABS and Aseptic Processing Technology will feature top aseptic processing experts from FDA, Merck, Merck Vaccines, Genentech, Novartis, BiogenIdec, AstraZeneca, Boehringer-Ingelheim and Eiasi, among others, as speakers and discussion leaders.
The Conference will consist of presentations, discussions and case studies related to two distinct tracks:
- Aseptic Processing Technologies and Disposables, led by Jörg Zimmermann, Director, Process Development and Implementation, Vetter Pharma Fertigung GmbH Co KG, Germany, and Klaus Ullherr, Product Manager, Robert Bosch GmbH, Germany
- Barrier Isolation and RABS, led by Jack Lysfjord, Principal Consultant, Lysfjord Consulting LLC, USA and Ryan Hawkins, Vice President of Operations & COO, Cook Pharmica, USA
The conference will also feature an "Ask the Regulators" panel discussion, which will ensure that all delegates have an opportunity to have their regulatory questions answered before the conclusion of the conference.
For a full list of conference sessions, speakers and registration details, please visit www.ISPE.org/2014AsepticConference. Members of the media may obtain credentials to cover the event by contacting [email protected].
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.
For more information contact:
Explosive growth in connected devices. Enormous amounts of data for collection and analysis. Critical use of data for split-second decision making and actionable information. All three are factors in making the Internet of Things a reality. Yet, any one factor would have an IT organization pondering its infrastructure strategy. How should your organization enhance its IT framework to enable an In...
Oct. 25, 2014 05:00 PM EDT Reads: 1,707
The major cloud platforms defy a simple, side-by-side analysis. Each of the major IaaS public-cloud platforms offers their own unique strengths and functionality. Options for on-site private cloud are diverse as well, and must be designed and deployed while taking existing legacy architecture and infrastructure into account. Then the reality is that most enterprises are embarking on a hybrid cloud...
Oct. 25, 2014 11:45 AM EDT Reads: 1,822
In her General Session at 15th Cloud Expo, Anne Plese, Senior Consultant, Cloud Product Marketing, at Verizon Enterprise, will focus on finding the right mix of renting vs. buying Oracle capacity to scale to meet business demands, and offer validated Oracle database TCO models for Oracle development and testing environments. Anne Plese is a marketing and technology enthusiast/realist with over 19...
Oct. 25, 2014 10:00 AM EDT Reads: 1,689
StackIQ offers a comprehensive software suite that automates the deployment, provisioning, and management of Big Infrastructure. With StackIQ’s software, you can spin up fully configured big data clusters, quickly and consistently — from bare-metal up to the applications layer — and manage them efficiently. Our software’s modular architecture allows customers to integrate nearly any application wi...
Oct. 25, 2014 10:00 AM EDT Reads: 1,768
As Platform as a Service (PaaS) matures as a category, developers should have the ability to use the programming language of their choice to build applications and have access to a wide array of services. Bluemix is IBM's open cloud development platform that enables users to easily build cloud-based, creative mobile and web applications without having to spend large amounts of time and resources o...
Oct. 25, 2014 08:00 AM EDT Reads: 1,762
The Internet of Things will greatly expand the opportunities for data collection and new business models driven off of that data. In her session at Internet of @ThingsExpo, Esmeralda Swartz, CMO of MetraTech, will discuss how for this to be effective you not only need to have infrastructure and operational models capable of utilizing this new phenomenon, but increasingly service providers will nee...
Oct. 24, 2014 09:30 PM EDT Reads: 1,400
When you set off to build an app that will change the world, designing your system architecture to be reliable and scalable is important but the stark reality is that, for your MVP, you probably had a “need for speed” (of development). You didn’t know what all the axes were to scale your application, where your stress points would be, and what weird and wonderful ways your customers would use it d...
Oct. 24, 2014 09:00 PM EDT Reads: 1,202
Compute virtualization has been transformational, yet security policy implementation and enforcement has lagged behind in agility and automation. There are a number of key considerations when implementing policy in private and hybrid clouds. In his session at 15th Cloud Expo, Holland Barry, VP of Technology at Catbird, will discuss the impact of this new paradigm and what organizations can do to...
Oct. 24, 2014 07:00 PM EDT Reads: 1,523
Samsung VP Jacopo Lenzi, who headed the company's recent SmartThings acquisition under the auspices of Samsung's Open Innovaction Center (OIC), answered a few questions we had about the deal. This interview was in conjunction with our interview with SmartThings CEO Alex Hawkinson. IoT Journal: SmartThings was developed in an open, standards-agnostic platform, and will now be part of Samsung's Ope...
Oct. 23, 2014 11:45 PM EDT Reads: 2,683
SYS-CON Events announced today that Red Hat, the world's leading provider of open source solutions, will exhibit at Internet of @ThingsExpo, which will take place on November 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA. Red Hat is the world's leading provider of open source software solutions, using a community-powered approach to reliable and high-performing cloud, Linux, ...
Oct. 23, 2014 11:30 PM EDT Reads: 1,727