Regulatory Affairs

Regulatory Affairs White Papers

View white papers from other Pharmaceutical sectors:
16-30 of 52 results
Brexit Implications for UK Pharmaceutical Administration with NSF
| By NSF International
With the historic vote by the UK to leave the European Union we have been asked by many of our clients and colleagues “What will the vote to leave the EU (Brexit) mean for pharmaceutical quality management and the role of the Qualified Person (QP)?” The only thing that is certain is that we are facing at least two, and probably more, years of unprecedented uncertainty.
Regulatory Affairs > White Papers
NSF: Techniques to tackle our current Complexity Crisis
| By NSF International
Over the last 30 years we have seen levels of complexity in the pharma industry increase dramatically. It’s getting close to a crisis point. Although some complexity is triggered by events we can’t influence (regulations, globalization and the like), most is created by choice.
Regulatory Affairs > White Papers
What NSF’s Remediation Projects Are Saying About the Industry
| By NSF International
NSF Pharma Biotech Consulting is in a unique position in that our team is regularly and intimately involved in a range of GMP remediation projects across the world and across all dosage forms. Offering companies a different perspective on current industry thinking or for us to review and verify that the proposed CAPA will be effective across the full range of key attributes. These attributes include cost, timeframe, GMP compliance, sustainability, simplicity and ease of presentation to clients and regulators.
Regulatory Affairs > White Papers
NSF: What Works and What Doesn’t When Changing your Quality Culture and Improving GMP Behaviors
| By NSF International
Ever wondered why 70% of change initiatives fail, or why 95% of New Year’s resolutions are forgotten by February? The same reason traditional training methods have little impact on workplace behaviors, and why the “carrot and stick” (reward vs. punishment) approach to changing behaviors doesn’t work. In this article, we detail how to really change your quality culture and improve GMP behaviors.
Regulatory Affairs > White Papers
So How Is NSF Moving E.A.S.T.?
| By NSF International
How does an organization stand out from the crowd in the global marketplace, where businesses vie for attention and custom, and a multitude of choices exist in every transaction? Communication that seeks a change in an organization has to be Easy, Attractive, Social, Timely (E.A.S.T)
Regulatory Affairs > White Papers
Reliable, Long-range Wireless Sensors for Environmental Monitoring
| By Vaisala pbr
The Vaisala viewLinc Monitoring System tracks environmental conditions wirelessly using Vaisala’s VaiNet wireless devices based on LoRa™* technology. By using a chirp spread spectrum (CSS)* wireless protocol, VaiNet provides robust communication that is extremely reliable over long distances and under harsh, complex and obstructed conditions.
Regulatory Affairs > White Papers
Autoinjectors From Planning to Launch
| By SHL Group
Injectable drug delivery devices such as pen injectors and autoinjectors show a significant growth potential in the future. This white paper focuses on the development process of an autoinjector project from planning to launch and best practices on how to prepare for and address potential challenges along the way.
Regulatory Affairs > White Papers
Specialised Project & Technology Transfer- Laboratory Equipment & Automated Systems
| By SHL Group
A US-based company dedicated to developing intelligent inspection solutions and equipment for the biotechnology, pharmaceutical, and medical device industries wanted to partner with an established manufacturer, possessing design and engineering capabilities as well as appropriate in-house quality systems. With lab equipment that finds defects in medical syringes, vials, cartridges, test tubes, and other medical containers, it was vital for the manufacturing partner to have ISO13485 and ISO9001 quality systems in place.
Regulatory Affairs > White Papers
Complex Module Manufacturing – IC testing Devices
| By SHL Group
An established manufacturer of Integrated Circuit (IC) testing equipment from Germany was following a global sourcing initiative and needed to search for a suitable supplier in Asia that had experience in manufacturing and offered strong production capabilities. Sustaining high quality manufacturing in an environment with established quality systems was vital to the manufacturer and became one of the key determining factors when choosing the right supplier.
Regulatory Affairs > White Papers
Specialised Project & Technology Transfer – Precision Neurosurgical Equipment
| By SHL Group
An established manufacturer of Integrated Circuit (IC) testing equipment from Germany was following a global sourcing initiative and needed to search for a suitable supplier in Asia that had experience in manufacturing and offered strong production capabilities. Sustaining high quality manufacturing in an environment with established quality systems was vital to the manufacturer and became one of the key determining factors when choosing the right supplier.
Regulatory Affairs > White Papers
Supply Chain Management – Surface Mount Technology & Solar Cell Manufacturing
| By SHL Group
A leading provider of screen printing equipment located in the UK with an established presence in China was looking for a manufacturing partner that was capable of taking over their supply chain management while maintaining international quality standards. With markets largely located in Asia, the company hoped to find a partner within the region that not only possessed the key manufacturing capabilities required, but one that could also offer western style management to ensure that the technology transfer would go smoothly.
Regulatory Affairs > White Papers
Single-Use-Bioprocesses – Hype or Future Technology?
| By Rentschler
Single-use bioreactors offer many advantages for the manufacturing of biopharmaceuticals. They are used in approximately two thirds of all new bioprocesses in the biopharmaceutical market and have become indispensable in biopharmaceutical development and production processes.
Regulatory Affairs > White Papers
Best Practices for Streamlining Electronic Implementation of Established COAs; Copyright January 2015
| By ERT
This paper addresses the best practices for building an electronic Clinical Outcome Assessment (eCOA) solution in support of clinical research as it relates to the operational and licensing compliance aspects of administering COAs on electronic platforms.
Regulatory Affairs > White Papers
Symptoms and Impact of COPD Assessed by an Electronic Diary in Patients with Moderate-to-Severe COPD: Psychometric Results from the SHINE Study; International Journal of COPD; January 2015.
| By ERT
This paper presents the results of psychometric assessment data from a COPD eDiary developed by Novartis to provide a more detailed assessment of symptom frequency and severity and their impact on patients with COPD.
Regulatory Affairs > White Papers
The Use of Ambulatory Blood Pressure Monitoring in Drug Development; Copyright, January 2015
| By ERT
This white paper delves into the basics of blood pressure, along with the well-documented limitations of standard and digital office blood pressure measurements. It reviews ABPM device functionality, common drug classes where blood pressure monitoring comes into play and compares the advantages and disadvantages of different monitoring options in clinical studies.
Regulatory Affairs > White Papers
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