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John Warne

US FDA Releases Final Food Safety Rules To Prevent Food-Borne Illnesses - 0 views

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    Out of the seven major rules, the US Food and Drug Administration (FDA) finalized the first two rules in the landmark FDA Food Safety Modernization Act (FSMA), applying greater control to how certain types of food is prepared to prevent food-borne illness.
Online Compliance

Export of FDA Regulated Products- Export Documents - 0 views

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    This webinar will provide guidelines on how to get export certificates from FDA, and common issues faced by exporters of FDA-regulated products.
bheru_kumar

Antibody Cocktail Market 2022: Revenue Growth, Key Factors, Major Companies, Forecast T... - 0 views

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    A recent report was published by Reports and Insights which provides extremely crucial and in-depth knowledge about the title "Antibody Cocktail Market: Opportunity Analysis and Future Assessment 2022-2030" this report enlightens the readers about the current market dynamics of the market, its opportunities and challenges along with its future in the coming years. A synopsis of the market size and in-depth comprehension of the facts directed most meticulously and thoroughly for the development of the relevant market. Moreover, to make it more valuable for the readers, there is an extensive conceptual framework along with accurate information and some interesting graphical representation. The report further also aims to fulfil the essence of quantitative and qualitative synopsis which reflects upon the conceptual framework and pragmatic methodology of the market.  The study report includes a top line data with respect to number of trials and their standard enrollment in top countries conducted globally. The study provides coverage of malady clinical trials by region, country, different phases, segments and trial status along with end points status and sponsor type. Furthermore, report also provides leading drugs for currently active trials with qualitative data. Reports and Insights clinical trial study reports are prepared using Reports and Insights existing and research proprietary database, pharma database, and pre-clinical trials database. Clinical trials are gathered and grouped from various available registries in clinical trials, journals, news, and other authentic sources available worldwide. Clinical trials database includes synchronized updates through internal dynamic processes. Request a Sample Copy of this Report @: https://reportsandinsights.com/sample-request/1373 Antibody Cocktail Introduction The world has been through immensely challenging times in the past year due to the sudden strike of Coronavirus disease 2019 (COVID-19), caused by a n
The Dollar Business

Lupin got FDA approval for Armodafinil Tablets - 0 views

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    Lupin Limited (Lupin), a transnational pharma company, announced on Wednesday that its US-based subsidiary Lupin Pharmaceuticals, Inc (LPI) has got the final approval from FDA for its Armodafinil Tablets, used in treatment of obstructive sleep apnea
Online Compliance

FDA Inspection-FDA Inspection Preparation - 0 views

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    A guide to prepare oneself for an FDA examination particularly for senior, QA, regulatory management and quality system auditors.
Online Compliance

A Guide on Federal Rules and Regulations - 0 views

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    How to avoid getting warning letters from FDA regulations? How to react when the letter is received? Learn more about FDA regulations in this upcoming webinar.
Online Compliance

FDA CSV Requirement | Best Practices CSV - 0 views

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    Learn to develop a standard approach to predicting and identifying trends through research, networking and understanding FDA-regulated marketplace.
jacob logan

FDA approves Xvivo Perfusion System in lung transplant - 0 views

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    Steen Solution Perfusate to heSwedish medical technology firm Xvivo Perfusion has received the US Food and Drug Administration (FDA) approval for the use of its Xvivo Perfusion System with lp in lung transplant procedure.
jacob logan

Magnetic hearing devices may interfere with shunt systems, says FDA - 1 views

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    The US Food and Drug Administration (FDA) has issued a statement warning healthcare providers about potential complications in patients fitted with both programmable cerebrospinal fluid (CSF) shunt systems and certain magnetic hearing devices.
jacob logan

FDA labels Ethicon surgical staplers recall as Class I - 1 views

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    The US Food and Drug Administration (FDA) has labelled a recall of circular staplers by Johnson & Johnson (J&J) unit Ethicon as Class I, or high risk.
Online Compliance

Webinar-FDA Requirement for Quality Agreements - 0 views

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    This webinar will review FDA’s regulations related to suppliers in manufacture and testing of drugs, biologics and medical devices.
Online Compliance

New Rules for FDA Regulation of Lab Developed Diagnostic Tests (LDT) - 0 views

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    Attend this upcoming webinar to learn new updated FDA rules and regulations of Lab Development Diagnostic Tests (LDT) and labeling, marketing practices.
Online Compliance

FDA Regulation of Molecular Diagnostics- DNA Testing - 0 views

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    Physicians, hospitals, clinical trial users, reimbursement experts, regulators must attend this webinar to learn how FDA regulates molecular diagnostic tests.
Online Compliance

FDA Regulations for Cosmetics-GMP Compliance - 0 views

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    Golden chance to learn in-depth about FDA’s regulations and how they are applied to the cosmetics industry. Register for this webinar today.
Online Compliance

Effective Root Cause Analysis: The key to an effective corrective actions system - 0 views

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    In this presentation you will learn the importance of root cause analysis and how it fits into an effective corrective and preventive action system. We will cover where else in your quality management system it can be used, and describe some of the techniques for effective root cause analysis. Examples will be cited to illustrate how each technique works. Corrective Actions are one of the top areas of FDA 483 citations from audits they perform at medical device manufacturers. The FDA once shut down almost all the diagnostic manufacturing of a company that consistently failed to implement an effective corrective action system. To have an effective corrective action system, you must do a good job of understanding the root cause of the problem you are dealing with. This seminar will give you tips on some of the best and most effective ways to do root-cause analysis.
Online Compliance

Best Practices-Notified Bodies Audits-FDA Inspections - 0 views

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    Every medical device professional must attend this session to learn about the requirements to prepare for FDA inspections, EU Notified Body audits.
Online Compliance

Supplier Quality Agreements-EU-FDA Guidelines - 0 views

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    Webinar on CMO Supplier Quality Agreements and methods to Comply with new FDA and EU Guidelines for Contract Drug Manufacture.
jacob logan

FDA rejects Helius Medical Technologies' PoNS device - 0 views

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    The US Food and Drug Administration (FDA) has rejected Helius Medical Technologies' premarket submission for the Portable Neuromodulation Stimulator (PoNS) device due to a lack of data.
jacob logan

Avanos Medical to reduce opioid use with pain management pump - 0 views

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    Avanos Medical has secured US Food and Drug Administration (FDA) 501(k) clearance for its postoperative pain management device ON-Q Bolus.
jacob logan

FDA approves Innoblative's radiofrequency ablation device - 0 views

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    The US Food and Drug Administration (FDA) has granted clearance to Innoblative Designs' electrosurgical device SIRA RFA.
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