Upon completion of this webinar you will be able to:
- Understand the basics of GLP and basic good documentation practice
- Be able to adopt GLP requirements into your daily work tasks and non-clinical projects
- Know the roles and functions of key personnel within a GLP study
- Be able to develop GLP compliant documentation
- Understand the Quality Assurance Unit and its role in GLP management responsibilities in a GLP context
Training agenda:
- Introduction
- History and Overview of the GLPs
- Scope and Definitions
- Organization & Personnel
- Test System Care & Facilities: buildings and equipment
- Rules for the conduct of studies: (General Aspects, The Study Plan or Protocol, Standard Operating Procedures (SOPs)
- Test/Control/Reference Substances
- Study Conduct and Raw Data
- Record Retention, E-data Considerations, Archives
- Disqualification, Effects of Non-Compliance
- QA Department
- Regulatory Affairs inspections
- Q&A Session
Who Should Attend:
- Scientists (managerial and laboratory)
- Quality Assurance and Quality Control Managers
- Regulatory Affairs and Compliance Personnel
- Principal Investigators
- Study Coordinators
- Clinical Research Monitors
- Study Directors
- All professionals active in pre-clinical studies, suitable for both new and experienced staff from the pharmaceutical, cosmetics and other industries
Fee:
59 EUR
Register for another webinar and get 10% discount
Date of Session:
To be confirmed
Technical Information:
Session will be conducted on-line via a web meeting. Each participant will receive a unique user ID and login to access the session.