Search Results - online compliance training

1. Online Course Offer 2017 by GlobalCompliancePanel @ 10$
September 14, 2017

Not come across the online course offer 2017 by GlobalCompliancePanel @ 10$ yet? You don’t know what you have been missing. First of all, what is this online course offer 2017 by GlobalCompliancePanel @ 10$ about? Is it about any other of the thousands of products that are available in the market for $10? No way! This online course offer 2017 by GlobalCompliancePanel @ 10$ is about the unlikeliest of products that you could pay $10 for: Webinars that offer regulatory trainings! What? A training webinar, that too on such a niche area as regulatory compliance, at all of $10? Sounds incredulous, ... (read more)

Author: John Robinson

2. Adherence to GMP is absolutely essential for Quality Control and Contract Laboratories
November 21, 2016

It is absolutely essential for contract laboratories to maintain the required standards of Quality Control because of the risk their process involves: After testing and approval, drug products and Active Pharmaceutical Ingredients (APIs) are released to the market without further check. This fact is the primary reason for which regulatory agencies such as the FDA, EMA and many others place the highest emphasis and priority on inspections of QC laboratories. This is also one of the main reasons for which a huge number of QC related 483's and Warning Letters get issued to companies that have pr... (read more)

Author: John Robinson

3. A complete understanding of the payroll law
November 18, 2016

Those who are responsible for payroll or employer tax withholding compliance or have just been hired or promoted into the payroll department would have discovered during their indoctrination just how important this role is to the success of the organization. Their learning is a continuous process that goes on and on. Employees in this position need to build a solid foundation for handling their company's payroll obligations and complying with federal and state payroll laws. They need to be familiar with how to find the authoritative laws to support their policies and procedures. Clear and ... (read more)

Author: John Robinson

4. Identifying and managing key risks is the primary purpose of HR auditing
November 17, 2016

Human resources audit should qualify as the most important of all audits of an organization. This is because HR auditing is directly related to employees. This resource, the organization’s human capital, is the organization’s most important resource. It is through an HR audit that an organization evaluates this resource’s strengths and weaknesses. HR audits help organizations in a number of ways HR auditing helps organizations achieve this in many ways. Through HR audits, organizations are able to eliminate human capital risks, which will lead them to core actions such as ascertaining poten... (read more)

Author: John Robinson

5. An understanding of HIPAA upcoming changes for 2016
November 16, 2016

Professionals at various levels of the healthcare industry need to have a grasp of the HIPAA Security/Privacy Rule and the way it relates to their practice or business. A two-day, in person, live seminar being organized by GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, will offer this very important understanding. Brian Tuttle, a Certified Professional in Health IT (CPHIT), Certified HIPAA Professional (CHP), and Certified Business Resilience Auditor (CBRA) , who brings over 15 years’ experience in Health IT and Compliance Consulting,... (read more)

Author: John Robinson

6. Getting Design of Experiments and Statistical Process Control right for Process Development and Val
November 15, 2016

Procedures must be used in the application of DOE and SPC to the development, design and monitoring of manufacturing and testing processes. Why this needs to be done is because the FDA has, in a recent guidance document on Process Validation, assigned the responsibility for reviewing and interpreting DOE and SPC studies to the Quality Unit. Going about doing this work requires a practical orientation. It calls for an approach with case studies and examples. A seminar that is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance a... (read more)

Author: John Robinson

7. Getting design controls right is absolutely essential for medical device companies
November 11, 2016

Design Controls are absolutely essential for ensuring the safe and effective production of medical devices. The FDA too considers design Controls a critical process. Yet, design controls are among the most frequently cited areas for 483 and Warning Letter observations from the FDA. Although intrinsic quality, safety, and effectiveness of a device are known to be established during the design phase; a significant percentage of all medical device recalls are due to design problems, as statistics show. The implications of poor design of medical devices controls are quite obvious: o They accou... (read more)

Author: John Robinson

8. Extracting Information from Geochemical Data
November 10, 2016

Going beyond just asking the laboratory for geochemical extracting information of a gold test by sampling every meter of the drill core of a trench and using multielement analysis is an approach strongly recommended by most mining specialists. There exist other methods of geochemical data analysis techniques and obtaining geochemical extracting information, but these are largely ignored by the industry. Making sense of the geochemical extracting information How to make sense of the geochemical extracting information is the core of a webinar that is being organized by GlobalCompliancePanel, ... (read more)

Author: John Robinson

9. 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

10. Article based on Effective and Efficient Internal
November 08, 2016

A 510(K) is a premarket submission made to FDA to demonstrate that a device to be marketed is at least as safe and effective, meaning that which is substantially equivalent, to a legally marketed device that is not subject to premarket approval (PMA). There are three types of Premarket Notification 510(K)’s that may be submitted to FDA: Traditional, Special, and Abbreviated. Product modifications that could significantly affect safety and effectiveness are subject to 510(K) submission requirements under 21 CFR 807 as well as design control requirements under the Quality System (QS) regulation... (read more)

Author: John Robinson

11. 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

12. 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

13. 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

14. 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

15. 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

16. 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

17. 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

18. 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

19. 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

20. 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

21. 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

22. 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

23. 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

24. 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

25. 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