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All Blog Posts Tagged 'laboratory' (8)

A clear process for compliant laboratory OOS investigations

The core of successful operation by a drug maker is laboratory testing. current Good Manufacturing Practices (cGMP) regulations require a drug manufacturer to use laboratory testing as a tool to validate that everything that goes into a laboratory product, such as in-process materials, finished materials, and containers adhere to set specifications. When all these are done, a major challenge for laboratories is in how to deal with a test that shows an…

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Added by Adam Fleaming on September 12, 2017 at 5:58am — No Comments

Learn any professional courses for $10 only

GCP Offer 4

Want to enhance your regulatory compliance career by learning a new course? All that it costs is $10. Yes, GlobalCompliancePanel, a provider of professional trainings, is offering hundreds of high value regulatory compliance courses for a mere $10…

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Added by John Robinson on August 18, 2017 at 7:08am — No Comments

Implementing ICH guidelines-compliant validation

Laboratory, Medical and Device2.jpg

Professionals in the field of statistical analysis need to possess clarity on understanding and interpreting statistical concepts used to investigate quantitative ICH Guidelines, such as:

  • Analytical methods validation
  • Procedures and acceptance criteria in calibration limits…
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Added by John Robinson on July 24, 2017 at 6:06am — No Comments

Validation the complies with ICH guidelines



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Added by John Robinson on June 5, 2017 at 7:24am — No Comments

Validation in accordance with ICH guidelines

Chemical

Professionals in the field of statistical analysis need a clear and perceptive insight into how to understand and interpret statistical concepts used to investigate quantitative ICH Guidelines such as analytical methods validation, procedures and acceptance criteria in calibration limits. Along with these, process and quality controls, as well as ICH Q8 and Q9 also need to be properly and thoroughly understood.

The ICH tripartite-harmonized ICH…

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Added by John Robinson on May 3, 2017 at 6:18am — No Comments

Getting laboratory noncompliance practices out of the way

It is absolutely necessary for all laboratory personnel to be aware of the current compliance issues and the ways of preventing FDA 483 and Warning Letter observations. To do so, they must:

o  Be proactively alert

o  Identify problem areas, and

o  Implement corrective actions in order to prevent regulatory actions.

How do laboratories make this happen? Are there specific methods and procedures that they must keep in mind that will help them be…

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Added by Adam Fleaming on September 28, 2016 at 6:15am — No Comments

OSHA publishes new educational materials on protecting workers from hazards found in laboratories

Check out the Laboratory Safety Procedures and the new Lab Safety Document

 

WASHINGTON – The Occupational Safety and Health Administration (OSHA) today published new educational materials (http://www.osha.gov/SLTC/laboratories/index.html) for…

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Added by Henry Wilter on October 13, 2011 at 12:53pm — No Comments

NEW LAB CAPABILITIES ANNOUNCED BY FAUSKE & ASSOCIATES, LLC

Fauske & Associates, LLC, the World Leader in Nuclear and Chemical Process Safety, announces new laboratory capabilities with the expansion of state-of-the-art equipment and space. FAI has doubled its Accelerating Rate Calorimetry (ARC) testing capabilities, yielding quicker test turnaround times. ARC provides thermal hazard evaluation of products, reaction mixtures and intermediates. The experimental results are used for reactor and pilot plant safety analysis. It determines the… Continue

Added by Ashley Swanson on July 9, 2009 at 11:30am — No Comments

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nicolewells posted a discussion

Security Storage SAN Performance

Hello All,Have a question regarding SAN performance specifically EMC VNX SAN. I have a significant number of processes spread over number of blade servers running concurrently. The number of processes is typically around 200. Each process loads 2 small files from storage, one 3KB one 30KB. There are millions (20) of files to be processed. The processes are running on Windows Server on VMWare. The way this was originally…See More
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Rebecca Lewis posted a discussion

What safety signs should I acquire for my shop’s construction?

Hello everyone! The construction of my new flower shop will start next month, and it’s a big project for me. Since the shop’s location is near the main road, I want to make sure that everyone is safe during the work. I can’t afford any accident like people getting injured. So I’m thinking of purchasing construction health and safety signs from a supplier that my friend recommended.…See More
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Rebecca Lewis joined Safety Community's group
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Construction

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Adam Fleaming posted a blog post

FMEA in medical devices can work better when mated with ISO 14971

Failure Mode and Effects Analysis (FMEA) is a core aspect of risk management and risk analysis in medical devices. FMEA is essentially about analyzing the reasons for which a problem arises and the effects it has on the system. In the field of medical devices, it is absolutely critical to understand the failure mode and effects because the consequences of not doing this can be disastrous and many times, even…See More
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Security Storage SAN Performance

Hello All,Have a question regarding SAN performance specifically EMC VNX SAN. I have a significant number of processes…Continue

Tags: san, vmware, emc

Started by nicolewells yesterday.

What safety signs should I acquire for my shop’s construction?

Hello everyone! The construction of my new flower shop will start next month, and it’s a big project for me. Since the shop’s location is near the main road, I want to make sure that everyone is safe…Continue

Started by Rebecca Lewis yesterday.

Gig Economy

The career world has rapidly changed and these days, long-term careers and people working in just one job are slowly but steadily becoming a thing of the past. In fact, according to research, in the…Continue

Tags: field, engineer, IT, freelance, economy

Started by Mohd Azher on Wednesday.

How to Repair MySQL InnoDB Table That Has Issues?

When trying to run: delete IdentityRequest *I get an error of sailpoint.tools.GeneralException: null index column for collection: sailpoint.object.IdentityRequest.itemsDoing a select * from…Continue

Tags: course, sailpointonline, sailpoint

Started by Soujanya Naganuri on Tuesday.

Occupational Health and Safety 7 Replies

Health and safety are important aspects of an organisation’s smooth and effective functioning.  Did you know that workplace health & safety injuries cost Australian businesses over $60 billion…Continue

Tags: Safety, and, Health, Occupational

Started by WHS Solutions. Last reply by Tony Ferraro Feb 18.

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