Outlines

• 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 Days