Good Laboratory Practice

Pious Laboratories Pvt. Ltd. has always been offering brilliant technical courses that cover every aspect of planning and design, research, and manufacturing to maintenance and management, and beyond. The Good Laboratory Practice Course is one of those best technical courses.

 

Good Laboratory Practice

 

The Good Laboratory Practice Course comprises of the following modules:

  • Background
  • Historical perspective (GLP)
  • Historical perspective (GLP)
  • Fraud and misinterpreted data
  • FDA’s reaction
  • EPA’s reaction
  • National and international GLP regulations
  • Memoranda of Understanding (MOU) and bilateral agreements
  • Who has to comply with GLP/cGMP regulations?
  • Non-clinical laboratory studies
  • Analysis under GMP and cGMP
  • Availability of regulations and guidance documents
  • GLP/GMP key provisions
  • GLP organization and conditions
  • Study director
  • Quality assurance unit (QAU)
  • Standard operating procedures (SOPs)
  • Deviations and changes
  • Reagents and solutions
  • Expiration date
  • Storage conditions
  • Test and control articles
  • Characterization
  • Stability
  • Storage container
  • Standards
  • Raw data
  • The laboratory notebook Transcriptions to computers
  • Direct data capture by a computer
  • Modification of raw data Integrity Storage and archiving
  • Facilities
  • Time period
  • How should electronic records be stored?
  • Subcontractors
  • Personnel Documentation of qualification
  • Part-time or full-time personnel
  • Health precautions and safety
  • Equipment
  • Introduction to GLP/cGMP How to conduct a GLP study
  • Meet data recording requirements and Changes
  • Automated data collection systems
  • Enforcement of GLP
  • Frequency of inspections
  • Guide to inspection of pharmaceutical quality control
  • Guide to investigating out of specifications (OOS) test results
  • Surviving an audit and inspection, Preparation, Conduct and Close