COURSE NAME:Good Laboratory Practice


UPCOMING EVENTS


START DATE END DATE CITY/COUNTRY PRICE Request
This course can be scheduled at your convenience, to request this course please click here
INTRODUCTION:

 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) . 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. This GLP overview is particularly adapted for training all levels of an organization on the requirements of this standard

OBJECTIVES:

 

  • 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
OUTLINE:

 

  • Scope.
  • Definitions.
  • Inspection of a testing facility.
  • Personnel.
  • Testing facility management.
  • General.
  • Definitions of terms
  • GOOD LABORATORY PRACTICE PRINCIPLES
  • Test facility management's responsibilities
  • Study director's responsibilities
  • Principal investigator's responsibilities
  • Study personnel's responsibilities
  • Quality assurance programme
  • Facilities
  • Apparatus, material and reagents
  • Test systems
  • Standard operating procedures
  • Performance of the study
  • Reporting of study results
  • Storage and retention of records and materials
WHO SHOULD ATTEND:

 Good Laboratory Practices (GLP) generally refers to a quality system of management controls for laboratories and research organizations that regulates how non-clinical safety studies are planned, performed, monitored, recorded, reported and archived. Many Bioanalytical laboratories have also chosen to follow GLP as the quality system for the control of testing for pharmacokinetic and other clinical studies.

This GLP training course is designed for all Scientists (managerial and laboratory), Regulatory Affairs and Compliance personnel who are active in regulated laboratory studies. It will be of most benefit to professionals whose job function necessitates the generation, evaluation, assurance and submission of laboratory data to regulatory agencies. Principal Investigators, Study Directors, Study Monitors and professionals aspiring to these positions will derive benefit from this course.

This course is also useful for quality assurance and quality control managers, coordinators of multi-site projects, regulatory affairs professionals, auditors, and senior management interested in effective QA techniques. New and experienced staff from the food, pharmaceutical, medical device, nutraceutical, agrochemical and cosmetics industries will learn the fundamental principles and applications of GLP, particularly in the complex multi-site environments of today’s industry. The course will also benefit professionals from CROs that operate under the GLPs.

 

DURATION:
    • 5 Day(s)
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    Sabic

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    Sabic

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    Mobily

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    General Authority of Civil Aviation (GACA)

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    Sabic

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    Sabic

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    Coldstorec Group Of Saudi Arabia

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    Saudi Aramco

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    Al-Suwadi Services

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    Al Khodari Company

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    Al Khodari Company

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    Al Khodari Company

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    Al Khodari Company