Online Safety Community

Ensuring the accuracy, reliability and consistency of analytical data in laboratories

Ensuring the accuracy, reliability and consistency of analytical data in laboratories

The basic reason for which analytical methods and procedures need to be validated is to ensure that analytical data have consistency, accuracy and reliability. This becomes possible when laboratories employ proper scientific methods and procedures and validate analytical methods and procedures. This is the only means to ensure that the analytical data are reliable, consistent and accurate.

The aim of doing so is to substantiate the suitability of intended use of a particular test. It also confirms that the quality, purity, identity and strength parameters required for a product produced in the laboratory are fulfilled in the required and set measure.

The acute need for validation of analytical data

A number of reasons can be ascribed for why analytical data has to be validated for the criteria described above:

  • The quality of the data is best indicated and assessed by validation;
  • This is a means to ensure the trustworthiness of the analytical data;
  • All these steps – validation, verification and transfer of analytical methods -are set out by regulatory the different regulatory bodies such as the FDA and the EMA, and standards such as the USP and ICH requirements, and are thus part of regulatory requirements.

Method validation and compendial methods

Ensuring the accuracy, reliability and consistency of analytical data in laboratories3

Lately, regulatory agencies and industry task forces have been taking a more than cursory interest in method validation. The FDA, as well as the EMA, have recently come up with guidelines on method validation and transfer. Also, USP has proposed new chapters for approaches to the following important areas:

  • Integrated validation
  • Verification and transfer of analytical procedures
  • Equivalency testing and for statistical evaluation.

Compendial methods

That compendial methods are verified needs to be demonstrated in two aspects:

  • The suitability of laboratories to successfully run the method, and
  • To demonstrate through testing that transfer of methods, when carried on between laboratories, is successful. When a laboratory intends to use an alternative method in place of a compendial method, verification of compendial measures should establish the equivalency of the alternative method.

Complete learning on validation, verification and transfer of analytical methods

Ensuring the accuracy, reliability and consistency of analytical data in laboratories1

All the issues relating to validation, verification and transfer of analytical methods will be taught during a two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance. Ludwig Huber, the director and editor of Labcompliance, the global online resource for validation and compliance and highly respected author of several books on compliance, will be Director at this seminar.

Interested in gaining complete knowledge of all areas relating to validation, verification and transfer of analytical methods? Then, please register for this seminar by visiting Ensuring the accuracy, reliability and consistency of analytical da....

This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Meaningful learning over two days

Ensuring the accuracy, reliability and consistency of analytical data in laboratories4

Dr. Huber will familiarize participants of this event with the background needed for getting a proper understanding of the requirements that need to go into validation, verification and transfer of analytical methods. The strategies needed for this, which he will explain, will constitute an even more significant learning.

The Director of this seminar will provide tools to implement most critical requirements, along with templates and examples for developing inspection-ready documentation. At this highly interactive seminar, Dr. Huber will augment the workshop with exercises into and between the presentations. Around half of the total time will be dedicated to practical sessions with real life examples.

Participants will also be offered a variety of tools that the Director of this seminar will offer them, such as SOPs, validation examples and checklists. All of these will be made readily available on a dedicated website, and can be used to easily implement the learning gained in the course.

Views: 116


You need to be a member of Online Safety Community to add comments!

Join Online Safety Community

Take our poll!

Take our poll!

Latest Activity

HrishikeshRam posted a photo

Nebosh course in Chrennai | Safety training institute

Learners seeing for NEBOSH Training Course in Chennai and other safety officer course in Chennai should direct their requests to the below mentioned address details.In Green World Group we provide NEBOSH, IOSH, HAZOP and various Customized and…
8 hours ago
G L Deepa posted photos
8 hours ago
Nakul Pratap posted photos
8 hours ago
Arifa Khan posted photos
8 hours ago


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 9 hours ago.

How to Repair MySQL InnoDB Table That Has Issues?

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

Tags: course, sailpointonline, sailpoint

Started by Soujanya Naganuri yesterday.

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 on Sunday.

About sailpoint software

An identity management system refers to an information system, or to a set of technologies that can be used for enterprise or cross-network identity management. Additional terms are used synonymously…Continue

Tags: sailpoint

Started by sujathayarlagadda on Friday.

What can be essentials safety measures taken to secure campus?

Students safety inside and outside the school premises is a huge concern in today's risk environment. what measures should be taken to ensure campus security?Continue

Tags: security, campus

Started by Jen McDade Feb 6.



© 2018   Created by Safety Community.   Powered by

Badges  |  Report an Issue  |  Terms of Service