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Search Results - corporate complia

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Showing 1 to 18 of 18 Articles matching 'corporate complia' in related articles.
Pages: 1

1. Ways of conducting a hassle-free internal and supplier audit for medical devices
November 09, 2016

Carrying out efficient and effective internal and supplier audits that meet all the requirements of external auditors is a must for medical device manufacturers. These audits should not only serve this purpose; they should also add value to the medical device organization. Part of both ISO 13485 and QMS Internal audits are required as part of ISO 13485 and the FDA’s Quality System Regulation (QMS). However, these procedures are quite complicated for many professionals in the medical device industry. They are often confusing and cumbersome, mainly because of the jargon and regulatory langua... (read more)

Author: John Robinson

2. Article based on Applying ISO14971 and IEC62304
November 07, 2016

Diligent, complete and correct implementation of risk management of software used in medical devices that takes into consideration the gaps and corrects them from the start of product development is absolutely imperative. This is because of two critical reasons: 1. Gaps, incorrect or incomplete implementation can retard or delay or make the certification/approval of medical products impossible; 2. Since most activities are closely linked to the development lifecycle; almost none of it can be retrospectively performed. This renders all activities performed till the identification of gaps usel... (read more)

Author: John Robinson

3. Article based on Applied Statistics with Emphasis
November 02, 2016

Evaluating product and processes is an imperative for almost all design and/or manufacturing companies. These are the reasons for which this evaluation needs to be made: o Managing risks o Validation of processes o Establishing product/process specifications to QC to such specifications o Monitoring compliance to such specifications Lack of proper and thorough grasp of and correct implementation of statistical methods leads a company to having to face significant increases in its complaint rates, scrap rates, and time-to-market. As a result, such companies churn out poor quality in thei... (read more)

Author: John Robinson

4. Tools and Methodologies to Predict and Improve Product Reliability
October 27, 2016

Improving product reliability may be the primary objective of reliability analysis; yet, there are many possible reasons for collecting and analyzing reliability data. There are many examples of collecting and analyzing reliability data. This could be done to assess product reliability in the field. It could be to predict product warranty costs. It could be for estimating replacement part/spares requirements. Other examples of collecting and analyzing reliability data include: o To assess the effect of a proposed design change o To demonstrate product reliability to customers or government... (read more)

Author: John Robinson

5. Article based on Human Subjects Research Seminar
October 26, 2016

Protection of human subjects and everything relating to it is of paramount importance for those involved in or wanting to be involved in research dealing with human subjects or an individual's private identifiable information. For these individuals, professionals and companies, it is extremely important to understand that there are federal regulations that must be followed. There are also state statutes, institutional policies, federal guidance documents, and ethical codes that guide the conduct of the research. This is done to ensure that the research not only meets the regulatory requireme... (read more)

Author: John Robinson

6. Assessment-based prediction is an effective tool for hiring the right candidate
October 25, 2016

Assessment-based prediction is an effective tool for hiring the right candidate Undoubtedly, hiring should rate as being among the most important activities for an organization. This is so because it is through this process that the organization takes in its most important resource –people. At the time of hiring, as well as while considering promoting, HR and the other important decision makers need to make up their mind by asking critical questions with which to make predictions about a potential hire. These questions could relate to how well the resource can perform in the assigned role, fo... (read more)

Author: John Robinson

7. New Way of Exploring Economic Environment
October 24, 2016

Lineament analysis in geological exploration The existence of efficient and cost-effective methods that help to identify prospective targets that are related to or are influenced by tectonic structures is not common knowledge among professionals in the field of geological exploration. The right sampling and Quality Assurance/Quality Control (QA/QC) procedures are essential in all aspects of the mineral deposit evaluation process to achieve the best possible confidence in resultant mineral resource and reserve estimates. Getting Quality Assurance and Quality Control procedures and protocol... (read more)

Author: John Robinson

8. Comprehensive risk management is a must for medical device software
October 21, 2016

Diligent, complete and correct implementation of risk management of software used in medical devices that takes into consideration the gaps and corrects them from the start of product development is absolutely imperative. This is because of two critical reasons: 1. Gaps, incorrect or incomplete implementation can retard or delay or make the certification/approval of medical products impossible; 2. Since most activities are closely linked to the development lifecycle; almost none of it can be retrospectively performed. This renders all activities performed till the identification of gaps usel... (read more)

Author: John Robinson

9. Understanding supplier management for medical devices
October 20, 2016

The problem with a supplier management program lies in the fact that the FDA audits suppliers only for finished devices. Because of this, manufacturers need to have a high degree of control over them. So, where is the problem? It lies in the FDA’s interpretation of these expectations. This keeps changing from time to time. Over the past five years, these expectations have changed considerably. Manufacturers whose devices have been around for more than five years need to thus make substantial changes into their cGMPs, hence the emphasis on the ‘c’, meaning “current”. A seminar from the guru... (read more)

Author: John Robinson

10. Procedures and documents in importing and exporting
October 19, 2016

If exporters and importers operating in this global economy need to meet customers’ demands and expectations; they need to have a solid understanding of a few necessary procedures and documentations. These relate to Operation Analysis, Preliminary Considerations, Sales Agents' Roles and Responsibilities, License Policies and Applications, Purchase Transactions, and Distributor and Sale Agent Agreements. An understanding of the basic definitions of these documents and their purpose, the roles of an exporter and importers in any type of business organization, and the basic principles and rules ... (read more)

Author: John Robinson

11. Developing Documents and Records to meet the Requirement of ISO 17025
October 19, 2016

The major challenge for most laboratories is having to develop and implement a functional Quality Management System (QMS) that not only complies with the management and technical requirements of the ISO/IEC 17025:2005 standard, but also meets the laboratory’s needs. This is why QMS is considered the soul of the ISO/IEC 17025:2005 standard. A highly meaningful and valuable learning session on how to accomplish this is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance. The Director at this two-day seminar is Michael Bro... (read more)

Author: John Robinson

12. Putting a well-rounded and comprehensive Quality Management System
October 06, 2016

An efficient and effective Quality Management System (QMS) is a critical factor for the success of medical device companies. Having an effective QMS in place is absolutely necessary for medical device companies that have to satisfy the needs of all of their stakeholders. Further, an effective QMS is a means to ensuring that a medical device company’s products are safe and effective for its customers. A medical device company has to show compliance with the necessary regulations. It should also enable the company to successfully demonstrate that compliance to the regulators. At the same time,... (read more)

Author: John Robinson

13. A learning session to help understand the role of statistics in manufacturing
October 04, 2016

Statistics and manufacturing make a made-for-each-other pair. Surprised? Although the connection between the two may not ring a bell at first mention; this association is deep and intertwined. This is because statistics takes manufacturing to higher levels by advancing its precision. Manufacturing is all about being process oriented, and statistics is a major tool in helping manufacturing realize its goal of precision. This link helped GlobalCompliancePanel, a leading provider of regulatory compliance trainings for all the areas of regulatory compliance provide a highly relevant and valuable ... (read more)

Author: John Robinson

14. Verification vs validation is a key understanding for regulatory professionals
September 28, 2016

For regulatory professionals, aspects of verification and validation, such as how to get verification and validation right, and an understanding of the ways in which verification and validation diverge from each other and converge, make up very important learning. The key point is that verification and validation should be risk based and be built keeping in mind the extant regulatory expectations. Building a verification and validation process that sufficiently uses targeted and documented risk based verification and validation test case elements or scripts is the foundation to this. All thes... (read more)

Author: John Robinson

15. Get your HIPAA compliance right in six simple steps
September 27, 2016

The most important element that Covered Entities and Business Associates must keep in mind while carrying out HIPAA audits is best summarized in the words of Jocelyn Samuels, the top Federal official in charge of HIPAA enforcement. To quote her own words, Covered Entities and Business Associates must ensure compliance through “... a comprehensive and thorough approach to assessing and addressing the risks to all of the Protected Health Information (PHI) they maintain”. Although Risk Analysis is mandatory; HIPAA audits of 2012 showed that as many as four fifths of health care providers failed... (read more)

Author: John Robinson

16. Application of concepts and theories of clinical research
September 26, 2016

Protection of human subjects and everything relating to it is of paramount importance for those involved in or wanting to be involved in research dealing with human subjects or an individual's private identifiable information. For these individuals, professionals and companies, it is extremely important to understand that there are federal regulations that must be followed. There are also state statutes, institutional policies, federal guidance documents, and ethical codes that guide the conduct of the research. This is done to ensure that the research not only meets the regulatory requireme... (read more)

Author: John Robinson

17. Handle internal investigations thoroughly, else employees could approach law agencies
September 23, 2016

Employees have a right to approach external sources such as the Equal Employment Opportunity Commission (EEOC), the National Labor Relations Board (NLRB), Wage and Hour, private attorneys, and juries against the employers, when feel that their legitimate complaints are not being heard by their employers. But first, a clear definition has to be made of what constitutes legitimate complaints and a distinction has to be made between legitimate and unsubstantiated complaints. This is because employers are legally empowered and obliged to carry out certain kinds of investigation, namely the kind ... (read more)

Author: John Robinson

18. Maximizing profits and patient outcomes during times of dwindling reimbursements
September 22, 2016

Shrinking professional services reimbursements from all insurance companies is a fact that all practices are facing. With patient footfalls falling and operating costs skyrocketing; there is a need for everyone to look at ways by which to generate additional revenue opportunities with their existing patient base and at the same time, maximize patient clinical outcomes. There exist methods by which all these goals can be achieved. The ways of doing this will be the subject of a two-day seminar that is being organized by GlobalCompliancePanel, a well-known provider of professional trainings fo... (read more)

Author: John Robinson

Pages: 1



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