Regulatory Affairs

Regulatory Affairs White Papers

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16-30 of 48 results
NSF: Remediation of Pharma Quality Systems – It’s All About the People
| By NSF International
Much of NSF Pharma Biotech Consulting’s work involves helping companies remediate flawed quality systems. This is usually done as a result of threatened or actual enforcement action by regulatory agencies. In these circumstances, companies are desperate and willing to do ‘whatever it takes’ without a full understanding of what that means. While expansive in concept, ‘whatever it takes,’ for many, means simply deploying internal and external resources to design and document a new quality management system. This is a significant commitment by management in resources, but unless the cause (how did this happen?) is also considered, the effort is doomed to fail.
Regulatory Affairs > White Papers
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
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
The Use of Continuous ECG Recordings (Holters) in Drug Development; Copyright, December 2014
| By ERT
Continuous 12 lead ECG recorders, often referred to as Holter devices, offer specific advantages to be considered over the standard 12 lead ECGs often collected during clinical trials for cardiac safety. This white paper explores the history of Holters, how sponsors, sites, and patients use these devices, and the benefits of continuous ECG recordings.
Regulatory Affairs > White Papers
Predictive Value of Baseline electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) Assessments for Identifying Risk of Prospective Reports of Suicidal Behavior During Clinical Research; Innovations in Clinical Neuroscience; November 2014
| By ERT
This meta-analysis examined the ability of baseline eC-SSRS lifetime suicidal ideation and behavior categories to predict prospective reports of suicidal behavior in psychiatric and non-psychiatric research participants. The review of over 74,000 eC-SSRS assessments determined that increasingly more severe lifetime suicidal ideation at baseline was associated with a progressively greater likelihood of prospectively reported suicidal behavior during study participation.
Regulatory Affairs > White Papers
How the Vaisala Continuous Monitoring System Aids Compliance with Title 21 CFR Part 11 and EU GMP Annex 11
| By Vaisala pbr
This white paper outlines how Vaisala’s Continuous Monitoring System helps to meet the requirements of Title 21 CFR Part 11 and EU GMP Annex 11 as they apply to environmental monitoring and validation.
Regulatory Affairs > White Papers
GMP Warehouse Mapping - Step-by-Step Guidelines for Validating Life Science Storage Facilities
| By Vaisala pbr
This step-by-step paper describes how to map a warehouse to comply with internationally recognized GMPs and regulatory requirements.
Regulatory Affairs > White Papers
16-30 of 48 results