All Blog Posts (1,472)

FDA regulation on medical device packaging design

The FDA has regulations on medical device packaging design. This is quite natural, considering that the FDA has several regulations on all aspects of medical devices. However, it needs to be mentioned that the FDA regulation that covers medical device packaging design – Sec. 820.130 Device packaging under Subpart K–Labeling and Packaging Control -is a single liner, which only merely states that “each manufacturer shall ensure that…

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Added by Adam Fleming on February 16, 2018 at 4:46am — No Comments

Benefits of Risk Management in all Industries 2018

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Added by John Robinson on February 15, 2018 at 4:35am — No Comments

Medical Device Process Validation is the Key Part of a Quality Process

Process validation is one of the essential functions of a quality system for medical devices. Medical device manufacturers who have to stay compliant with regulatory requirements have to obtain premarket approvals (PMA), as well as premarket notifications for both new and modified existing medical devices. The key to all these is medical device process validation.

The FDA…

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Added by Adam Fleming on February 14, 2018 at 5:04am — No Comments

Ways of managing risk in construction projects

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The ways of managing risk in construction projects need to be drilled down into the systems that are used in construction projects. Managing risk in…

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Added by John Robinson on February 14, 2018 at 4:59am — No Comments

How is Risk Management Important to Project Success?

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The answer to how risk management is important to project success is best illustrated by the fact that no project has ever succeeded without proper risk…

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Added by John Robinson on February 13, 2018 at 5:06am — No Comments

Risk management methods and tools in the pharmaceutical and life sciences industries

Understanding and implementing risk management methods and tools is crucial for the pharmaceutical and life sciences industries in view of the fact that errors in this area can lead to dangers for human life. Since any mistake in any chain of in this industry can lead to serious consequences; the FDA and other regulatory…

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Added by John Robinson on February 12, 2018 at 5:09am — No Comments

It is important for organizations to validate their own Excel Spreadsheet Application

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Added by John Robinson on February 9, 2018 at 4:50am — No Comments

What is Emergency Planning and Community Right-to-Know Act (EPCRA)?

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…

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Added by John Robinson on February 8, 2018 at 5:03am — No Comments

OSHA’s standard on Respiratory Protection Safety Management Systems

Respiratory protection safety management system is a need for people who work in areas that require respiratory systems. Such people are exposed to various types of contamination, because of which they will be required to put on protective systems. The aim…

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Added by John Robinson on February 7, 2018 at 4:54am — No Comments

Medical Devices is aimed at ensuring very high quality assurance standards

Process validation for medical devices is a key ingredient of quality assurance in medical devices. Process validation is the criterion for measuring the effectiveness of a quality system for medical devices. The first step that medical device manufacturers have to take to show compliance with regulatory requirements for new and modified existing medical devices is obtaining premarket approvals (PMA) and premarket notifications. Process validation for medical devices is…

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Added by Adam Fleming on February 6, 2018 at 5:10am — No Comments

What is an Environmental Impact Statement?

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Added by John Robinson on February 6, 2018 at 5:03am — No Comments

What is Accounting Fraud and How to Prevent Financial Statement Fraud

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Key Takeaway: An understanding of what is accounting fraud and how to prevent financial statement fraud is an…

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Added by John Robinson on February 5, 2018 at 4:54am — No Comments

What is a Performance and Talent Management System?

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Added by John Robinson on February 2, 2018 at 5:22am — No Comments

CISOs map out their cybersecurity plan for 2018

When Omar F. Khawaja compiled his priority list for 2018, he didn’t include which security technologies he wanted or how many IT staff he hoped to hire.

Instead, the CISO at Highmark Health — a healthcare management and insurance provider whose portfolio includes Allegheny Health Network, United Concordia Dental and Visionworks, among others — articulated an overarching strategy on how the cybersecurity plan should fit within the national organization’s business…

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Added by Adam Fleming on February 2, 2018 at 5:05am — No Comments

The role of packaging in food safety and security

The role of packaging in food safety and security is paramount. Perhaps no other factor plays the role of packaging when it comes to ensuring food safety…

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Added by John Robinson on February 1, 2018 at 5:00am — No Comments

Environmental, Health and Safety (EHS) Management and Audit

An environmental, health and safety (EHS) management and audit program is now a prerequisite for organizations in various kinds of business. Allied to the…

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Added by John Robinson on January 31, 2018 at 4:47am — No Comments

Developing an effective HR compliance program

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Added by John Robinson on January 30, 2018 at 5:09am — No Comments

How to choose a supply chain management solution

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Any business that opts for a supply chain management solution has to have clarity on how to choose a supply chain management solution. This is because the…

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Added by John Robinson on January 29, 2018 at 5:20am — No Comments

What is the purpose of lyophilization & Where it will be applied?

Lyophilization is the clinical term for freeze-drying. In the simplest terms, it can be described as a technical process in which the moisture level of many materials is reduced, most times frozen, for the purpose of creating a new product or an ingredient.

When an injectable drug is freeze-dried -this is the process of lyophilization -its compounds are stabilized. This reconstitution process is…

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Added by Adam Fleming on January 25, 2018 at 5:13am — No Comments

The Challenges before the Supply Chain Management and Logistics Industry

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A look at the challenges before the supply chain management and logistics industry is instructive. Huge figures sit rather incongruously with the reality of the industry, which is that while from a universal point of view, the industry has been growing at a steady rate and is set…

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Added by John Robinson on January 25, 2018 at 5:03am — No Comments