#dc comics#dc#bruce wayne#batman#dick grayson#dc fanart#tim drake#batfamily#batfam
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Ketemu teman top dari Medan Mas @iqbalhrp Dosen, Pemimpin Muda, investor di puluhan Daftar Efek IDX, Ketua PC HIPMI. #indef #ispe #nusantara137 #alkiramfoundation (at Hotel Bidakara Jl Jend Gatot Subroto Pancoran Jakarta Selatan) https://www.instagram.com/p/BqtVHsZAW75emIqLLEXsAGBkJdjg9PPXz2Ntc40/?utm_source=ig_tumblr_share&igshid=bcqf9nhrfvxx
A project for an institute of Specialization, if you love web design try to see it at this link: https://www.behance.net/gallery/41528279/ISPE-Web-Design
ISPE Sanità, esperienza e metodologia contro corruzione e sprechi
ISPE Sanità, esperienza e metodologia contro corruzione e sprechi
ISPE Sanità diventa il rappresentante dell’Italia in EHFCN. Francesco Macchia: “Portiamo esperienze e metodologie contro corruzione e sprechi in sanità”
LISBONA, 23 giugno 2016 – ISPE-Sanità rappresenterà l’Italia nello European Healthcare Fraud & Corrupution Network-EHFCN. Un organismo internazionale che vede la partecipazione dei ministeri della Salute di diversi Paesi europei, di autorità…
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Come visit us at ISPE in Las Vegas at booth 148 to learn how to maximize your productivity #throughput #Garvey #ISPE #vegas #maximize
ISPE Announces Drug Shortages Prevention Plan
ISPE, the International Society for Pharmaceutical Engineering, has announced that it will work with stakeholders world-wide to produce a Drug Shortages Prevention Plan to guide the pharmaceutical and biopharmaceutical industry in establishing supply chains that provide quality medicines to patients without interruption.
The plan, which will be based on ISPE research with the input of its membership, company leaders and regulators, will serve as a roadmap that when implemented, can significantly reduce drug shortages, according to an ISPE statement. It will address optimal organizational strategies, such as aligned governance and communication practices, effective manufacturing and quality systems, and appropriate measures of supply chain robustness and quality. This effort addresses rising concerns around drug shortages within companies, among global health authorities, and for patients.
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Source: http://www.pharmtech.com/pharmtech/article/articleDetail.jsp?id=841793&topic=402&cid=PHTE
Process Gases: Specifications, Testing, and Generation
On April 23rd 2014, the ISPE LA chapter held a meeting at the Amgen Conference Center about the generation, specifications, and testing of process gases.
In the first part of the meeting, speakers Phil Bowes, Director or Engineering at Amgen and Nick Haycocks, Senior QA Associate at Amgen, presented the ISPE good practices guide on process gases and process gas specifications.
As there is no risk based approach for process gasses defined for the industry, the expertise within the ISPE is key in designing cost effective engineering practices and efficient systems for process gases used in pharma manufacturing.
The gases talked about in this guide, such as N2, O2, Ar, CO2 and compressed air, are in direct contact with the product and require practical, cost effective systems for intended purposes.
This guide, in line with accepted industry practices, defines system parameters important to product quality and patient safety, management of facility installation and operational costs and provides a scientific risk-based approach to demonstrate compliance. The guide will overview the design development process flow, encompassing the user requirements, the generation and supply systems, distribution systems, control and monitoring, use of risk assessments, construction and its records, commissioning and verification and finally operation and maintenance.
The guide defines a risk based approach to the design and operation of process gas systems, including the identification of risk controls, means of detections and an assessment of the resulting risk level.
In the second part of the meeting, speaker Ruby Ochoa, owner of Trace Analytics LLC, talked about process gas compressed air testing, sampling and analytical methods.
Sampling methods for particles, water and oil (oil vapor, aerosol and liquid oil) were covered. For particle sampling, a laser particle counter is used to perform a background test and sampling tips were presented. For water measurement, devices such as hygrometers, psychrometers, electrical sensors or spectroscopic methods can be used. For oil, measurements can be taken for total or condensed hydrocarbons, oil mist or aerosols through various methods including spectroscopy, gas chromatrography and filtration through membranes.
In the third part of the meeting, speaker Andrew Castiglione, Account Manager, at Westair Gases and Equipment, discussed the methods for generation of gases and the control of quality parameters for pharmaceutical gases. The gases overviewed included atmospheric gases such as N2, O2, Ar, weird gases like CO2, pharma gases like H2, He, and other gases. Gas packaging methods such as single cylinders, liquid cylinders and other automated processes were discussed, along with methods to accurately track, categorize and date such cylinders via barcoding. Concerns of contamination and methods to analyze and verify the quality of the gas were also examined. To conclude, applications for each gas were covered: N2 for blanketing and preservation of biological samples, O2 for cell growth, fermenters and bioreactors, Ar for inerting, and CO2 for incubators and dry ice shipping.
ISPE CEO to Step Down at End of 2014
The International Society for Pharmaceutical Engineering (ISPE) has announced that CEO Nancy Berg will leave the Society when her three-year contract is completed at the end of 2014.
During her tenure with ISPE, Berg was responsible for the world’s largest professional society fostering dialog and education on technical, scientific, and regulatory best practices in the pharmaceutical and biotech industries. In a press statement, ISPE identified Berg as the architect of the Society’s ongoing strategic plan, focusing on initiatives related to drug shortages, quality metrics, global manufacturing quality, facility and supply chain issues, and patient experiences in clinical trials. She worked to create synergies between pharmaceutical industry stakeholders, bringing together diverse groups of professionals, regulators, and partner organizations to work on issues of shared concern.
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Source: http://complianceteam.tumblr.com/post/78847534258/ispe-ceo-to-step-down-at-end-of-2014
ISPE Study Reports on Root Causes for Drug Shortages
The International Society for Pharmaceutical Engineering (ISPE) has released results of a recent survey that find manufacturing quality systems to be the leading cause of drug shortages. The report states that factors resulting in drug shortages “are multi-factorial, often resulting from issues within the quality systems, which can be affected by key aspects of organizational governance and the quality of interactions with regulatory authorities.”
ISPE’s 2013 Drug Shortages Survey, part of the organization’s Drug Shortages Initiative, was sent to industry professionals and companies and was created to identify the technical, engineering, quality, and regulatory issues impacting drug shortages. Key findings cited in the survey were problems with manufacturing quality systems that included issues with aseptic processing equipment involved in the manufacture of sterile drugs. Respondents indicated that companies that had avoided supply shortages had an organizational focus on strong quality systems aimed at ensuring compliance. Lack of regulatory-company interaction was also cited as a problem. Respondents believed the quality of interaction with regulators could be improved.
Read more here.
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