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The Cutting Edge of Medical Technology Content, Community & Collaboration
Workplace health and well being is a rising public health concern. Poor employee health can be costly to the organization (e.g. absenteeism, poor productivity, reduced attention and workplace safety).
Chronic stress has been shown to impinge decision-making, reduce concentration, immune system responses, and job satisfaction, cause psychological distress (e.g. depression and anxiety) and coronary heart disease, and negatively impact client rapport and personal…
ContinueAdded by Roger Steven on November 21, 2018 at 7:18am — No Comments
Added by John Robinson on February 20, 2018 at 4:55am — No Comments
The Emergency Planning and Community Right-to-Know Act is a significant milestone in the detection and prevention of hazardous chemicals. The US Congress enacted this law in the wake of the Bhopal disaster in India. It seeks to involve…
Added by John Robinson on February 8, 2018 at 5:03am — No Comments
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Added by John Robinson on February 6, 2018 at 5:03am — No Comments
Key Takeaway: An understanding of what is accounting fraud and how to prevent financial statement fraud is an…
Added by John Robinson on February 5, 2018 at 4:54am — No Comments
Health Education England is launching an online workshop to gather views on digital readiness.
The organisation is working in collaboration with Digital Health and innovation and crowdsourcing agency Clever Together on the online workshop, which forms part of the…
Added by John Robinson on November 14, 2017 at 5:32am — No Comments
Murj, a new company backed by $4.5 million in new venture financing, is looking to make data collection from implantable heart monitoring and management devices easier and more manageable.
The company was founded by a former Medtronic sales rep who’d previously worked as a product manager on Apple’s iPads. After a few years in sales, Murj founder Todd…
Added by John Robinson on November 8, 2017 at 5:39am — No Comments
Process validation is the method of using data from stages ranging from the process design stage to production, to ensure that the process that is being used can deliver consistently high-quality products. Companies that come under the life sciences must comply with GxP regulations to ensure that their processes meet the regulatory guidelines to be GxP compliant.…
Added by John Robinson on November 8, 2017 at 5:37am — No Comments
The application of DOE and SPC to the development, design and monitoring of manufacturing and testing requires the use of procedures. Why? It is because in a recent guidance document on Process Validation, the FDA has named the Quality Unit as being responsible in the review and interpretation of DOE and SPC studies.
The Quality…
Added by John Robinson on November 2, 2017 at 6:49am — No Comments
What if your employer asked you to implant a microchip under your skin to help them keep track of you?
Three Square Market…
Added by John Robinson on October 4, 2017 at 6:41am — No Comments
The Occupational Safety and Health Administration (OSHA) today issued a Notice of Proposed Rulemaking to extend the employer’s responsibility to ensure crane operator competency and enforcement for crane operator certification to Nov. 10, 2018.
OSHA…
Added by John Robinson on September 5, 2017 at 7:29am — No Comments
Product Risk Management is a critical aspect of ensuring medical devices are safe and effective for intended uses. This course will help you understand the regulatory requirements, including ISO14971.
You’ll learn techniques that can help you identify hazards and potential harms. You’ll learn how to mitigate risk and effectively monitor risk to ensure your customers receive safe and effective products. A rigorous…
ContinueAdded by Adam Fleming on July 19, 2017 at 5:47am — No Comments
Overview of this session Product Risk Management is a critical aspect of ensuring medical devices are safe and effective for intended uses. This course will help you understand the regulatory requirements, including ISO14971, and how to create processes and procedures to implement them.
You’ll learn techniques that can help you identify hazards and potential harms. You’ll learn how to mitigate risk and effectively monitor risk to ensure your customers receive safe and effective…
ContinueAdded by Adam Fleming on July 13, 2017 at 5:43am — No Comments
Added by John Robinson on June 6, 2017 at 6:36am — No Comments
In late 2016, the US Environmental Protection Agency (EPA) revised Section 608, which deals with refrigerant management regulations. A number of requirements under this section are set to change. They concern the handling requirements that are applicable to ozone depleting refrigerants, and fortify the existing regulations by…
Added by Adam Fleming on May 16, 2017 at 6:33am — No Comments
There is the saying that after all is said and done, to err is human. In a philosophical sense, it can have numerous interpretations, but in the field of Good Manufacturing Practice, it cannot be taken with a pinch of fatalism. GMP requires everything to be precise and scientific to a T. GMP is not an area that leaves anything to human error. Being an area of science, GMP has no place for imagination and chance.…
Added by Adam Fleming on May 8, 2017 at 7:48am — No Comments
Audits are a means of evaluating operations and other functions of an organization. ISO 19011:2011 Guidelines for Auditing Management Systems describes audits as a process used for gathering the evidence of verifiable documents and map their suitability, alignment and fulfilment with the company’s policies and procedures.
An audit is an important tool that helps organizations to analyze opportunities, implement best practices, and assess all the important factors in…
Added by Adam Fleming on April 27, 2017 at 6:29am — No Comments
Added by John Robinson on April 25, 2017 at 6:18am — No Comments
Establishing Quality Systems is one of the central aspects of a medical device and/or pharmaceutical organization. Establishment of Quality Systems is also a regulatory requirement, as set out by the FDA and the ISO.
The process of establishment of Quality Systems for FDA-regulated medical devices industries is set out in 21 CFR Part 820. Further, the ISO has its standard for how to establish Quality Systems in medical devices industries –the ISO 13485 standard…
Added by Adam Fleming on March 28, 2017 at 9:06am — No Comments
Design of Experiments (DoE) is an important component in many industries. It is a series of tests or runs that is carried out repeatedly and consistently over a period of time, and its outputs or responses, observed. Design of Experiments is very important in industry to help arrive at an understanding of the predictability and reproducibility of an experiment.
Design of…
Added by Adam Fleming on March 8, 2017 at 5:12am — No Comments
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