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FDA-GLP Good Laboratory Practices (GLP) Training 21CFR5

Overview

GLP refers to a Quality Systems of management controls for laboratories and research organizations to ensure the consistency and reliability and reproducibility of results. The original regulatory enforcement was first published by FDA and then a few years later by EPA. It is also outlined in the Organization for Economic Co-operation and Development (OECD) Principles of GLP in 1992 and has since been added to many national regulations

Course Objective

This training course has been designed for individuals involved in manufacturing of Finished Pharmaceuticals products. It offers in-depth training on the FDA's GLP requirements.

The Online course will help to quickly and efficiently obtain training on the FDA's Good Laboratory practice (GLP) for Nonclinical Laboratory Studiesand to implement the Good Laboratory practice for Pharmaceuticals, Medical Device, Human Food, Neutraceuticals, OR a non-regulated industry test or research laboratory

Course length

This 8-hour GLP (0.8 CEU) overview is particularly adapted for training all levels of an organization on the requirements of this standard.

Who should attend

This 7Step/CALISO online training course is for you if you:

  • Want to quickly and efficiently get a comprehensive training of GOOD LABORATORY PRACTICES (GLP)
  • Want to improve your CV and career opportunities with qualifications in quality assurance
  • Do NOT have time to allocate two full days to take an live class
  • Want to train more of your staff on auditing economically and without having to immobilize them in a class for a full day

Course Benefits

Your company, and all who partake in the daily activities of running a laboratory or a research and testing center, will benefit from this course.

By participating in this 7 Step/CALISO online course, you will be able to:

  • Understand the high specific requirements and intent of this GLP regulation
  • Understand the GLP requirements and 21CFR58
  • Understand requirement for Good Laboratory Practices
  • Understand how the requirements should be implemented within your organization

Major topics include:

  • Scope.
  • Definitions.
  • Applicability to studies performed under grants and contracts.
  • Inspection of a testing facility.
  • Personnel.
  • Testing facility management.
  • Study director.
  • Quality assurance unit.
  • Animal care facilities.
  • Animal supply facilities.
  • Facilities for handling test and control articles.
  • Laboratory operation areas.
  • Specimen and data storage facilities.
  • Equipment design.
  • Maintenance and calibration of equipment.
  • Standard operating procedures.
  • Reagents and solutions.
  • Animal care.
  • Test and control article characterization.
  • Test and control article handling.
  • Mixtures of articles with carriers.
  • Protocol.
  • Conduct of a nonclinical laboratory study.
  • Reporting of nonclinical laboratory study results.
  • Storage and retrieval of records and data.
  • Retention of records.
  • Purpose.
  • Grounds for disqualification.
  • Notice of and opportunity for hearing on proposed disqualification.
  • Final order on disqualification.
  • Actions upon disqualification.
  • Public disclosure of information regarding disqualification
  • Alternative or additional actions to disqualification.
  • Suspension or termination of a testing facility by a sponsor.
  • Reinstatement of a disqualified testing facility Alternative or additional actions to disqualification.
  • Suspension or termination of a testing facility by a sponsor.
  • Reinstatement of a disqualified testing facility

Authors: CALISO Corporation

 

Required Prerequisites

This is an internet-delivered course featuring graphical presentation screens with text-based instruction, videos, and on-going quizzes to reinforce learning and retention and gauge your understanding of a topic before you move forward. Convenient and portable, this course provides instruction without the expense of travel and time away from the workplace.

  • Internet Access
  • Browser cookies enabled
  • Recent browser such as Internet Explorer, Firefox, Chrome or Safari recommended

Award of Certificate

An online training certificate will be issued upon successful completion of the course and obtaining 70% or above on the final average of the ongoing quizzes. A final Exam is provided for trainees who have less that 70%.

With your registration, you will receive online access to the course until you complete it. The limit on course completion and access to your certificate is three years.

Quantity Discounts

Quantity discounts of 15% for 10 or more students registered. The discount is automatically calculated during registration by credit card.

Course Registration

Product Code

Status

List Price

 

GLP

In Stock

$175.95



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FAQs and Course Technical Assistance

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