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| Articles by John Robinson |
41. 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 cha...
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42. 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 Responsibili...
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43. 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...
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44. Getting overtime pay calculation wrong can be damaging for the employer
October 18, 2016
A thorough grasp of the subtleties of the Fair Labor Standards Act (FLSA) continues to elude many employers, even though this Act has been around for a long time. The frequent changes that keep happening to the many regulations of the FLSA from time to time are one of the major reasons for this. The...
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45. Making sense of the FDA's GMP and Regulatory Expectations for Early IND Products
October 12, 2016
The FDA's recent guidance documents covering GMP requirements for Phase I products have considerably reduced some of the complexities early phase products face. These guidance documents are in addition to those that cover the CMC sections for IND submissions at Phase I. Although these new guideline...
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46. 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...
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47. 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 i...
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48. 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 ...
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49. 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 mus...
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50. 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 impor...
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Author: John Robinson
