UKCA stands for United Kingdom Conformity Assessed, and is applied to products placed on the market in the UK. This replaces the CE mark, which – pending changes to legislation - is recognised in the UK until the 30th June 2023. So from this date onwards, medical device manufacturers need to comply with the new UKCA marking regulations.
manufacturers now need to plan for how they will obtain a UK Conformity…
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Added by Neha on October 18, 2022 at 2:40am —
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Production and Process Controls (P&PC) are one of the key capabilities necessary for medical device companies to consistently and effectively produce safe and effective products.
Because Production and Process Controls are so critical they are one of the major subsystems emphasized in inspections by the FDA.
Failure to adequately implement Production and Process Controls (P&PC) can lead to disaster for your company or even worse for your customer. And…
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Added by Adam Fleming on March 5, 2020 at 6:22am —
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The Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11) clarifies and expands the regulatory requirements and procedures for submitting registration and results information for certain clinical trials to ClinicalTrials.gov, in accordance with Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801).
The Final Rule has been in effect since January 18, 2017. The…
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Added by Adam Fleming on February 18, 2019 at 6:22am —
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Compliance4All, a leading provider of professional training for all areas of regulatory compliance, is organizing a 90-minute webinar on the topic, “Dietary Supplements CGMPS – 21 CFR 111 Compliance”, on February 5. John E. Lincoln, a medical device and Regulatory Affairs consultant, will be the expert at this webinar.
Please visit http://bit.ly/2DIk8lf to enroll for this webinar.
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How to find the…
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Added by Adam Fleming on January 30, 2019 at 7:07am —
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The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic product into a common format (called the CTD - Common Technical Document) has improved the speed and efficiency for companies working in global development programs and clarified expectations by regulatory bodies. Reformatting for multiple submissions is substantially limited. The CTD has improved the regulatory review processes and enabled implementation of good review…
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Added by John Robinson on January 18, 2019 at 5:16am —
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Technical writing and its role within the life sciences. Technical writers produce a variety of technical documents that are required to manage and direct regulated operations and to meet regulatory requirements. We will spend some time in this webinar discussing those document types, their importance, and the consequences of the messages are unclear or misunderstood.
After setting the stage for this content, we delve into the writing process beginning with the audience and how the…
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Added by John Robinson on January 9, 2019 at 6:44am —
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A medical device inspection. Ah! Is there a more dreaded exercise for a medical device manufacturer? If I were given a choice between taking up the world’s toughest rated examination and facing a medical device inspection, I would gladly opt for the former. A medical device inspection should rank right there ahead of the most difficult examination or task.
Alright. We knew this fact all along. So, why should I intimidate you by casting such aspersions on a medical device inspection?…
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Added by Adam Fleming on October 30, 2018 at 6:29am —
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Requirements set out by the Occupational Safety and Health Administration (OSHA) are aimed at ensuring safety at the workplace. Formulated in 1971 under President Richard Nixon, it was one of the landmark legislations in any part of the world. Today, almost all kinds of workplaces in the US are regulated by OSHA.
Through its concerted efforts, OSHA has largely been a success, if one takes into…
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Added by Adam Fleming on September 14, 2018 at 6:25am —
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Good Clinical Practice (GCP) is a set of international standards meant for entities that conduct clinical trials. This set of standards, formulated by the International Conference on Harmonization (ICH), when implemented into clinical trials involving human subjects, seeks to ensure the protection of the humans involved in the research, as well as to bring about transparency in the methods of clinical practice.…
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Added by Adam Fleming on September 5, 2018 at 7:15am —
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Regulatory compliance is something organizations in most industries have to deal with. Almost every industry has its own set of regulations that are framed by the respective regulatory bodies. In niche areas such as medical devices, pharmaceuticals, healthcare, finance, aerospace, information technology and such others, the FDA has a very detailed set of regulations.
The aim of these regulations…
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Added by Adam Fleming on August 28, 2018 at 7:22am —
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When you work in an industry that is regulated by the FDA, one thing that is as certain as day and night is the fact of FDA regulation. Of course, this is as obvious as saying that solar power is derived from the sun and is as silly as asking if the FDA regulates FDA-regulated industries! The point being made is that regulation is the essence of the FDA’s existence. The FDA has been created to regulate certain industries with the intention of…
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Added by Adam Fleming on August 20, 2018 at 6:37am —
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Healthcare compliance trainings are undertaken to get a clear idea about the regulatory compliance requirements in the industry. Healthcare is a highly regulated industry, which means that the regulatory bodies keep issuing regulatory guidelines, standards or requirements from time to time, as the regulations come in. One question that could arise in the minds of readers is: is it necessary to get trained…
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Added by Adam Fleming on August 1, 2018 at 6:05am —
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Digital technology has been driving change throughout the life science industry for years, however the sector is currently standing on the precipice of revolutionary development – some organizations have already taken the jump towards a more digital future.
Data collection and visualization for decision making to improve the overall performance of themanufacturing supply chain is a huge opportunity for the life science industry, however it’s not about being new – it’s about using…
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Added by Adam Fleming on July 17, 2018 at 5:28am —
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Do you think Google will use Schema extensions built by experts?
Bill: There are subject matter experts and there are experts on creating Schema, and ideally an extension will involve both types of experts. To read up on extensions to Schema, there is a page on Schema.org…
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Added by Adam Fleming on July 9, 2018 at 6:49am —
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You may be familiar with blockchain as the technology powering bitcoin cryptocurrency. But blockchain’s potential goes far beyond this, with healthcare being just one of the industries set to be revolutionized. In an editorial published today in the International Journal of Health Geographics, Maged N. Kamel Boulos and…
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Added by Adam Fleming on July 6, 2018 at 4:57am —
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A NEW controversial system may soon see welfare recipients required to have their face scanned and analysed before they can access their payments.
The system, which will also affect people trying access Medicare and childcare subsidies, age pension and pay tax online, is part of a new biometric security program that is set to begin in October.
Under the new strategy those trying to access these government services will be required to take…
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Added by Adam Fleming on July 3, 2018 at 5:32am —
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A myriad of customer service channels exist today, such as social media, email, chat services, call centers, and voice mail. There are so many ways that a customer can interact with a business and it is important to take them all into account.
Customers or prospects who interact via chat may represent just one segment of the audience, while the people that engage via the call center represent another segment of the…
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Added by Adam Fleming on June 28, 2018 at 6:59am —
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Audits -both internal and external -are a vital tool for ensuring that a medical device or biotechnology product and its manufacturing operations meet prescribed regulatory requirements. Medical device and biotechnology auditors have guidelines on how to establish that the manufacturer has met standards such as ISO 13485, ISO 14971, or regulations such as 21 CFR Part 820.
Apart from going by these guidelines; the auditor…
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Added by Adam Fleming on June 14, 2018 at 7:18am —
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That pharmaceutical companies need to hire professionals with the requisite qualifications is beyond question. This is not only required for the smooth conduct of activities in their course of their day-to-day work, but also because the FDA has set out its requirements for the proper educational and skill set qualification of employees in this profession in 21 CFR 211.25(a).
This FDA section underlines the need for educational qualifications, training and experience to carry out their…
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Added by John Robinson on April 24, 2018 at 7:29am —
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FDA consulting services are those services that are offered by independent, mostly private companies in helping to meet FDA requirements. FDA consulting services are offered to organizations that have to meet FDA regulatory requirements. Many companies across the US and many other parts of the world specialize in offering FDA consulting services and these are often the main business for these…
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Added by John Robinson on April 12, 2018 at 6:46am —
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