Online Safety Community

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
  • Process and Quality Control
  • Process and quality controls
  • ICH Q8 and Q9.

The ICH tripartite-harmonized ICH Guideline on Text, which was previously coded as Q2A guideline, is the guideline the ICH has set out for analytical methods validation. It was finalized in October 1994 under Step 4. Identification of the various validation parameters that are required for a number of analytical methods is the aim of this guideline. It also lays down the characteristics and parameters that have to be taken into consideration when validating the analytical procedures that are included in the registration applications.

ICH tripartite-harmonized ICH Guideline on Methodology, which used to be previously coded as Q2B is the ICH guideline for procedures and acceptance criteria in calibration limits. Finalized in November 1996 under Step 4; this guideline extends the ICH guideline on Text, or what is called Q2A (mentioned above). It comprises the actual experimental data required, along with the statistical interpretation, for the validation of a variety of analytical procedures.

Current Step 4 for process and Quality Control

Laboratory, Medical and Device4

The Current Step 4 version of the ICH-harmonized Tripartite Guideline is the current guideline for process and Quality Control. The regulatory bodies of the three biggest pharmaceutical markets in the world, namely the US, the EU and Japan have recommended the final draft of this guideline for adoption.

Professionals who want to achieve harmonization in Quality Meeting are required to meet critical milestones. These milestones include conducting stability studies, understanding the way the studies define relevant limits for the testing of impurities, and following a more flexible approach to pharmaceutical quality that is based on the principles of Good Manufacturing Practice (GMP) risk management. The ICH’s Quality guidelines on harmonization relating to Quality cover the following areas:

Complete learning on the areas of Validation in accordance with ICH guidelines

Which laboratory records should be retained and for how long

Considering the complexity and the breadth of the issues associated with these techniques, which cover both the pharmaceutical and clinical applications, and considering that these techniques apply to a number of area such as stability testing, outlier analysis and risk management; it is important and necessary for professionals in this area to get proper guidance on validation.

GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance, will offer this learning at a seminar that it is organizing. The Director of this seminar is Dr. Alfred Bartolucci, who serves as Emeritus Professor of Biostatistics at the University of Alabama. To register for this seminar, please visit Implementing ICH guidelines-compliant validation. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

A thorough understanding of statistical concepts

Laboratory, Medical and Device3

The statistical concepts used for investigating quantitative ICH Guidelines, such as analytical methods validation, procedures and acceptance criteria in calibration limits, and process and Quality Control, as well as with ICH Q8 and Q9, will all be covered in depth at this seminar.

Although not a formal course in statistics, this seminar will offer an applied approach to the statistical techniques used and will show how to reasonably interpret them. This learning will help participants to address the various challenges facing pharmaceutical and biotechnology companies when they are required to quantify results in a meaningful interpretable manner through tabulations and graphical presentations.

The expectations of different regulatory agencies regarding the quantification and development of a sound statistical monitoring of a properly utilized, effective, and efficient process control will also be taken up for discussion at this seminar. Dr. Bartolucci will familiarize the participants with the critical aspects of the statistical methods. He will explain the practical application of these guidelines.

This seminar will offer the following learning objectives:

Views: 14

Comment

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

John Robinson posted a blog post

The FDA's requirements for non-IND Foreign Clinical Studies

The FDA grants marketing approval for certain types of medical products whose application is the result of foreign clinical studies, provided the products and the clinical studies meet certain conditions. The types of medical productshttps://globalcompliancepaneltraining.files.wordpress.com/2017/12/the-fdas-requirements-for-non-ind-foreign-clinical-studies-2.jpg?w=800&h=504…See More
13 hours ago
Training Doyens posted events
14 hours ago
John Robinson posted blog posts
Friday
Russel Stuart posted events
Friday

Forum

PEGA Axis error: Parser already accessed

We have a PEGA frontend, from in which we're keying in double byte characters like japanese and being send to allotted java webservice through axis. this is working best when we ship singlebyte…Continue

Tags: pega_training, pega_online, pega

Started by Soujanya Naganuri on Thursday.

VMware player error on install vmware tools.

 I've installed the last version of VMware player (4.0.2) and created a virtual machine with ubuntu 10.04. However, some operations with …Continue

Tags: training, online, vmware

Started by emmablisa Dec 1.

All About QlikView

QlikViewQlik relies on sophisticated analytics that enables data discovery using an in-memory engine to analyze data for patterns not visible via SQL data structures or queries. The company’s two…Continue

Tags: Safety, Qlikview

Started by nicolewells Nov 25.

Occupational Health and Safety 5 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 Tara safe Nov 16.

QlikView for its Safety Strategic Business Intelligence Solution Worldwide

QlikTech (NASDAQ:QLIK), a leading…Continue

Tags: Qlikview, safety

Started by nicolewells Nov 15.

Badge

Loading…

© 2017   Created by Safety Community.   Powered by

Badges  |  Report an Issue  |  Terms of Service