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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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Pega Robotic Automation BPM Online Training at Online

October 20, 2017 all day
Pega Robotic Automation is equipped with an operating system that allows organizations to control all their robotics processes from a location. In combination with the Pega 7 BPM platform and case management applications, companies can seamlessly integrate human actions with robot automation for optimal workflow.Pegasystems introduces Pega Robotic Automation. It is now fully merged and available on the Pega 7 platform for case and business process management (bpm) and the portfolio of customer…See More
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Learn How to Prevent Quality and Compliance Problems by having a strong system for Purchasing Controls!

In this era of globalization; outsourcing has become a major component of business. Outsourcing brings many benefits for companies. Short and long-term cost benefits, the ability to concentrate on their core activities and grow their business, and the freedom of avoiding the actual tasks that go into manufacturing are some of the stated…See More
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Risk Management Solutions

Risk is defined as the potential hazard, harm or side effect of an activity. Almost all activities come with some or another form of risk, which needs to be mitigated or eliminated. Risk management…Continue

Tags: risk, Banking, management, healthcare, Process

Started by John Robinson on Tuesday.

Occupational Health and Safety 4 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 John Robinson on Monday.

Introduction to PEGA-PRPC

Pega/PRPC is a popular rules engine and BPM tool from Pega systems that is gaining good market share among large corporations. Architects and developers build the Pega/PRPC instance while…Continue

Tags: training, course, online, pega

Started by Soujanya Naganuri Oct 6.

Introduction to PEGA-PRPC

Pega/PRPC is a popular rules engine and BPM tool from Pega systems that is gaining good market share among large corporations. Architects and developers build the Pega/PRPC instance while…Continue

Tags: training, course, online, pega

Started by Soujanya Naganuri Oct 6.

Introduction to PEGA-PRPC

Pega/PRPC is a popular rules engine and BPM tool from Pega systems that is gaining good market share among large corporations. Architects and developers build the Pega/PRPC instance while…Continue

Tags: training, course, online, pega

Started by Soujanya Naganuri Oct 6.

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