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Health & care: Analytical Method Validation Under Good Laboratory Practices - GLPs

Good Laboratory Practices,Health & care, Pharmacy,Medicine,Medical teaching

NetZealous LLC

Summary

Price
£140 inc VAT
Or £46.67/mo. for 3 months...
Study method
Online
Duration
1 hour · Self-paced
Access to content
6 months
Qualification
No formal qualification
Certificates
  • Certificate of completion - Free
Additional info
  • Tutor is available to students

Overview

If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP.

All methods must be validated, the proof that they do what is claimed. Common criteria are accuracy, precision, linearity, range, and several more.

This webinar will discuss the best practices of analytical method validation, including components of a validation, how to include critical reagents comparison, selectivity experiments, assessment of stability, importance of communication between the development and the validation labs and accuracy of transfer documents (SOPs).

Participants will understand - Is validation a regulated activity? When to pull the trigger for validation? Importance of suitability testing.

Description

Why you should Attend:

Any laboratory that supports products for sale or use in the United States must follow Good Laboratory Practices (GLP), a comprehensive system that guarantees validity of results. If you work in pharmaceuticals, chemicals and petrochemicals, and environmental analyses then you are mandated to be following GLP. One of the major tasks in GLP is validation of an analytical method. The new pharmaceuticals are very often completely new compounds, structures never studied before by chemists. Their properties - such as solubilities and acid-base nature, are unknown. Synthetic reactions may make many similar types of molecules, including structural and optical isomers. The methodologies that mean US Food and Drug Administration compliance with GLP require a separation to be able to separate and identify all major, minor, and trace components. It is no longer just determining a purity of the main component. Each minor contaminant or degradation product is also important in GLP.

This analytical method validation webinar will provide practical tips on how to validate an analytical method under the GLP requirements. It is recommended for laboratories that are under, or want to be under, Good Laboratory Practices (GLP).

Areas Covered in the Session:

  • Method Validation
  • The Criteria for a Method
  • Statistical Requirements
  • Maintaining Compliance

Who is this course for?

  • Analysts
  • Lab Supervisors and Managers
  • QA Managers and Personnel
  • Consultants
  • Validation Specialists
  • Chemists

Questions and answers

No questions or answers found containing ''.

T Hussien asked:

What are the areas of work in the pharmaceutical industries after this course?

Answer:

Hello Hussien, Unfortunately, we will not be able to suggest on this. Please review the course overview for better understanding. Regards, NetZealous

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Adeniyi asked:

I am an Analytical Chemist & I'm interested in some of your courses. I will like to get more details. I will be glad if I can speak with someone.

Answer:

Hello Adeniyi, Kindly connect with our customer care for further details. Three Zero two - 358 2618 Regards, NetZealous LLC

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Certificates

Certificate of completion

Digital certificate - Included

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Legal information

This course is advertised on reed.co.uk by the Course Provider, whose terms and conditions apply. Purchases are made directly from the Course Provider, and as such, content and materials are supplied by the Course Provider directly. Reed is acting as agent and not reseller in relation to this course. Reed's only responsibility is to facilitate your payment for the course. It is your responsibility to review and agree to the Course Provider's terms and conditions and satisfy yourself as to the suitability of the course you intend to purchase. Reed will not have any responsibility for the content of the course and/or associated materials.

FAQs

Study method describes the format in which the course will be delivered. At Reed Courses, courses are delivered in a number of ways, including online courses, where the course content can be accessed online remotely, and classroom courses, where courses are delivered in person at a classroom venue.

CPD stands for Continuing Professional Development. If you work in certain professions or for certain companies, your employer may require you to complete a number of CPD hours or points, per year. You can find a range of CPD courses on Reed Courses, many of which can be completed online.

A regulated qualification is delivered by a learning institution which is regulated by a government body. In England, the government body which regulates courses is Ofqual. Ofqual regulated qualifications sit on the Regulated Qualifications Framework (RQF), which can help students understand how different qualifications in different fields compare to each other. The framework also helps students to understand what qualifications they need to progress towards a higher learning goal, such as a university degree or equivalent higher education award.

An endorsed course is a skills based course which has been checked over and approved by an independent awarding body. Endorsed courses are not regulated so do not result in a qualification - however, the student can usually purchase a certificate showing the awarding body's logo if they wish. Certain awarding bodies - such as Quality Licence Scheme and TQUK - have developed endorsement schemes as a way to help students select the best skills based courses for them.
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