scholarly journals Insight into the New EU GMP Annex 1

2021 ◽  
Author(s):  
Frank Panofen, ◽  
Daniele Pandolfi ◽  
Maurizio Della Pietra ◽  
Anna Campanella ◽  
Giulia Artalli ◽  
...  
Keyword(s):  
Risk Management ◽  
Control Strategy ◽  
Successful Implementation ◽  
Contamination Control ◽  
Analysis Process ◽  
Process Understanding ◽  
Management Concepts ◽  
Clear Differentiation ◽  
Insight Into ◽  
The Eu

The 2020 release of the EU GMP Annex 1 draft includes a new chapter on viable and non-viable environmental and process monitoring. The contamination control strategy and its dependence on trend analysis, process understanding, thorough investigation, and a commitment to progress is now an essential activity referenced multiple times through the document. There is also clear differentiation between qualification and monitoring, and quality risk management concepts are critical to successful implementation of system controls.

scholarly journals Challenges for successful planning of open and distance learning (ODL): A template analysis

2013 ◽  
Vol 14 (3) ◽  
pp. 81 ◽  
Author(s):  
Ansie Minnaar
Keyword(s):  
Higher Education ◽  
Distance Learning ◽  
Monitoring And Evaluation ◽  
Successful Implementation ◽  
Large Collection ◽  
Road Map ◽  
Analysis Process ◽  
Template Analysis ◽  
Open And Distance Learning ◽  
Insight Into

<p>How to plan an open and distance learning (ODL) unit in higher education is not clearly described in the literature. A number of ODL facilities at residential universities have not been successful because of a lack of planning or because of failure to ensure that all the different systems for ODL delivery were in place and functioning. This paper sheds light on how to plan strategically and how to implement an ODL unit at an existing university.</p><p>A template analysis was used to construct a road map for ODL planners. We used this analytical tool to organise data from a large collection of articles, books, and documents from 1980-2010. We purposefully chose template analysis as a document analysis process to foster the recurring themes found in published articles on planning and implementing ODL facilities in higher education.</p><p>The results indicate four main strategies for successful implementation of an ODL unit. The template consists of strategic planning, policies, systems, and challenges. It was concluded that the template for ODL planning offers new insight into distance education. It could be used as a foundation for ODL planning, implementation, monitoring, and evaluation. We recommend further research on the template with the aim of theory construction for ODL planning and implementation.</p>

Study of Establishing a Contamination Control Strategy using a Quality Risk Management for Manufacture of Sterile Products

Yakhak Hoeji ◽  
2021 ◽  
Vol 65 (6) ◽  
pp. 432-440
Author(s):  
Sangjae Lee ◽  
Jaeho Jung ◽  
Minyeong Shin ◽  
Intaek Jang ◽  
Taekyu Kim
Keyword(s):  
Risk Management ◽  
Control Strategy ◽  
Contamination Control ◽  
Quality Risk Management ◽  
Quality Risk

scholarly journals Application of an Innovative Model for the Risk Management of COVID-19 in a Multinational Manufacturing Company

2021 ◽  
Vol 13 (11) ◽  
pp. 5771
Author(s):  
Piero Lovreglio ◽  
Angela Stufano ◽  
Francesco Cagnazzo ◽  
Nicola Bartolomeo ◽  
Ivo Iavicoli
Keyword(s):  
Risk Management ◽  
Manufacturing Industry ◽  
Incidence Rates ◽  
Manufacturing Plants ◽  
Model Combining ◽  
Innovative Model ◽  
Global Prevention ◽  
The Relationship ◽  
Physician Team ◽  
The Eu

The COVID-19 incidence in 61 manufacturing plants in Europe (EU), North America (NA) and Latin-America (LATAM) was compared with the incidence observed in the countries where the plants are located in order to evaluate the application of an innovative model for COVID-19 risk management. Firstly, a network of local and global teams was created, including an external university occupational physician team for scientific support. In July 2020, global prevention guidelines for the homogenous management of the pandemic were applied, replacing different site or regional procedures. A tool for COVID-19 monitoring was implemented to investigate the relationship between the incidence rates inside and outside the plants. In the period of May–November 2020, 565 confirmed cases (EU 330, NA 141, LATAM 94) were observed among 20,646 workers with different jobs and tasks, and in the last two months 85% EU and 70% NA cases were recorded. Only in 10% of cases was a possible internal origin of the contagion not excluded. In the EU and NA, unlike LATAM, the COVID-19 incidence rates inside the sites punctually followed the rising trend outside. In conclusion, the model, combining a global approach with the local application of the measures, maintains the sustainability in the manufacturing industry.

A Contamination Control Strategy Gone Wrong

2021 ◽  
Vol 25 (5) ◽  
Author(s):  
Jeanne Moldenhauer
Keyword(s):  
Control Strategy ◽  
Control Strategies ◽  
Pharmaceutical Manufacturing ◽  
Production Facility ◽  
Vaccine Production ◽  
Contamination Control

Warning letters and regulatory inspection observation reports (e.g., FDA 483) often provide useful information for assessing risks in your facility and preparing for upcoming inspections. Starting with the updates to the European Union’s Annex 1 for the Manufacture of Sterile Drugs there has been an increased focus on contamination control strategies in facilities. A contamination control strategy is an integral part of pharmaceutical manufacturing, whether sterile or non-sterile. For this article we are going to look at a series of observations for a vaccine production facility and how we might learn from these observations. Highlighted are some of the contamination control issues. The FDA 483 Report was published in redacted form.

Customisable framework for project risk management

2017 ◽  
Vol 17 (1) ◽  
pp. 68-89 ◽  
Author(s):  
Jennifer Firmenich
Keyword(s):  
Risk Management ◽  
Management Practices ◽  
New Institutional Economics ◽  
Future Research ◽  
Project Risk Management ◽  
Management Process ◽  
Project Risk ◽  
Content Type ◽  
Risk Management Process ◽  
Management Concepts

Purpose The purpose of this paper is to emphasise on the need for efficient and effective project risk management practices and to support project managers in increasing the cost certainty of projects by proposing a new framework for project risk management. Design/methodology/approach The author adopts a “constructivist” methodology, drawing on practices common in construction management sciences and new institutional economics. Findings The author presents a holistic and customisable project risk management framework that is grounded in both practice and academia. The framework is holistic because, amongst others, all steps of the typical risk management process are addressed. The framework is customisable, because it allows for alternative ways of implementing the project risk management steps depending on the project-specific circumstances. Research limitations/implications The framework does not address the potential unwillingness of the project players to set up a project risk management process, at all. The proposed framework has not yet been tested empirically. Future research will seek to validate the framework. Originality/value The framework is designed to account for the difficult circumstances of a complex construction project. It is intended to support decision makers in customising a practical yet comprehensive project risk management concept to the characteristics of the unique project. Although many other project risk management concepts are designed based on the assumption that actors are perfectly rational and informed, this framework’s design is based on the opposite assumption. The framework is dynamic and should adapt over time.

scholarly journals Aflatoxin B1 risk management in Parmigiano Reggiano dairy cow feed

2016 ◽  
Vol 5 (1) ◽  
Author(s):  
Giorgia Canestrari ◽  
Barbara Ricci ◽  
Valentina Pizzamiglio ◽  
Alberto Biancardi ◽  
Pierluigi Piazza ◽  
...  
Keyword(s):  
Risk Management ◽  
Aflatoxin B1 ◽  
Dairy Cow ◽  
Control Program ◽  
Aflatoxin Contamination ◽  
Quality Control Program ◽  
Control Procedures ◽  
Feed Samples ◽  
Parmigiano Reggiano ◽  
The Eu

This study investigated aflatoxin B1 (AFB1) contamination in dairy cow feed and the risk management of AFB1 content in concentrates undertaken by feed industries in the Parmigiano Reggiano area. Data on aflatoxin contamination risk management applied in 29 feed industries were collected and the AFB1 content of 70 feed samples was analyzed. Data were collected within the framework of a quality control program promoted by the Parmigiano Reggiano Consortium in 2013 and 2014. Audit results showed that the control procedures to prevent AFB1 contamination mainly focused on maize and its by-products. AFB1 concentration resulted lower than 5 ppb (legal EU limit) in all samples; in one out of 70 samples, AFB1 content was 3.8 ppb and in all the other samples it was lower than 3 ppb. Results showed that AFB1 risk management applied by Italian feed industries effectively monitors AFB1 levels in feed below the EU legal limit.

scholarly journals THE RISK MANAGEMENT SYSTEM IS A TOOL FOR THE SUCCESSFUL IMPLEMENTATION OF INTERNATIONAL MEGAPROJECTS

2020 ◽  
Vol 11 (1) ◽  
pp. 98-103 ◽  
Author(s):  
D. V. Shamin
Keyword(s):  
Risk Management ◽  
Management System ◽  
Risk Tolerance ◽  
Successful Implementation ◽  
Monitoring And Control ◽  
Risk Management System ◽  
Management Processes ◽  
Integrated Risk ◽  
Risk Management Process ◽  
Integrated Risk Management

The article is devoted to the optimization of the processes of organization and management of international megaprojects based on the formation of a risk management system.Currently, the implementation efficiency of megaprojects remains low due to the emergence of many risks at various stages of project implementation.In this connection, it is proposed to form an integrated risk management system, which implies a three-stage structure for introducing the 6 element risk management system into the project life cycle, into the main project management processes.This article substantiates the need to form a risk management system in three stages in accordance with the key elements of a risk management system: (1) Planning – the block «Objectives and environment of the project»; (2) Approval of the project – the blocks «Identification», «Classification», «Assessment of risks and risk tolerance», «Risk management plan»; (3) Monitoring and control – the block «Control and monitoring of risks».Thus, the proposed integrated risk management system provides: continuity of the risk management process based on the audit of the RMS; the ability to adjust RMS at the stage of forecasting a risk event; possibility of scenario modeling for forecasting risk reduction potential; risk management program, formed by current risks in order to increase the attractiveness of the mega-project for the investor.It is also proposed to introduce an audit of risk management processes and procedures based on an adapted methodology for the following components of the risk management system: defining events and setting goals; the internal environment of the organization; organization risk assessment; risk control tools; responding to risks; communications and information; risk monitoring.This technique allows you to take into account risks not only at the stage of project development, but also during its implementation, which ensures its feasibility, as well as an audit algorithm for risk management systems of a megaproject is developed and recommendations for improving the RMS through this tool are proposed.

scholarly journals Proactive supply chain risk management approach: The case of Serbia

2017 ◽  
Vol 62 (214) ◽  
pp. 121-137
Author(s):  
Aleksandra Andjelkovic
Keyword(s):  
Risk Management ◽  
Supply Chain ◽  
Developed Countries ◽  
Management Approach ◽  
Supply Chain Risk Management ◽  
Supply Chain Risk ◽  
Underdeveloped Countries ◽  
Management Concept ◽  
The Republic ◽  
The Eu

Supply chain risk management has become imperative. Therefore, needs for proactive supply chain risk management continuously is growing. Proactive supply chain risk management is not a great problem in developed countries. The problem is present in transition countries and underdeveloped countries. In those countries has not been built awareness about the importance of networking through supply chains and risk management within the supply chain. One of them is Republic of Serbia. Outside the door of the EU, the Republic of Serbia still retains the characteristics of the old system, and that is the great limitation for implementation of proactive supply chain risk management concept. Basic aim of paper is to research the level of proactive supply chain risk management. By using an adequate statistical methods, in paper will be analysed group of large enterprises from the Republic of Serbia. Besides that, author of paper suggesting the reasons and consequences of lack of proactive supply chain risk management.

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