Purpose
This course has been designed to give attendees a good understanding of the regulations and principles of GLP (Good Laboratory Practices) and GDP (Good Documentation Practices), in order to apply them to different industrial climates, particularly chemical and petroleum companies.
Who Should Attend
Recommended attendees would include Directors and Managers of R & D, Quality Control, Quality Assurance, Instrumentation, Maintenance and Documentation. Representatives of company management would also benefit from an exposure to the matrix of requirements that are part of successful research projects in a regulated environment.
Course Description
- Introductions, Purposes of Course
- Purposes of Working under GLP Controls
- Role of Management
- Role of Study Directors
- Discussion/Questions
- Role of Quality Assurance
- Auditing
- Documentation Practices--Introduction
- Selection and Control of Vendors, role of Sponsors
- Protocols
- Study Reports
- Discussion/Questions
- Standard Operating Practices--Processing and Development
- Risk Management-Assessment of Processing Changes
- Workshop (Topic to be selected)
- Discussion/Questions
- Instrumentation Calibration
- Test Articles--Control of Processing and Components
- Reagents, Storage and Stability Testing
- Test Methods and Verification/Validation
- Deviations and Investigations, CAPA Discussion and Questions
- Documentation Practices--Paper Records
- Documentation--Electronic Records
- Data Storage and Retrieval
- Regulatory inspections
- Discussion/Questions
- Workshops (Documentation and other)
- Questions and Discussions
