New Requirements for Sponsors and Laboratories for Analyzing Clinical Trial Samples to Meet GCP/GCLP Internationally 2015 is a webinar that covers topics such as:
- What parts of GCP apply to clinical laboratories?
- What does GCP and the new guidance require of clinical laboratories?
- How to assess a clinical laboratory? Sponsor companies should assess the laboratory before placement to ensure that all aspects of GCP are satisfactorily addressed and that the laboratory standards and methods meet GCP requirements
- What standards should the laboratory be working to?
- Procedures for sample collection, receipt and application of acceptance/rejection criteria and for the preparation of reagents
- Facilities to assess the orderliness, cleanliness and environmental suitability of premises where study specific activities are to be carried out and the arrangements for storage of materials and samples
- What is required to ensure quality and appropriateness of methodology in use in any laboratory?
- What documentation should be available – including SOPs, validation, technical agreements
- What is the role of the sponsor company and laboratory during the study for ensuring clinical trials sample management and analysis to meet GCP requirements?
- What should be included in the contract between the laboratory and the sponsor?
New Requirements for Sponsors and Laboratories for Analyzing Clinical Trial Samples to Meet GCP/GCLP Internationally 2015 is intended for:
- Clinical research associates
- Clinical development managers and personnel
- Quality assurance managers and auditors
- Clinical research archiving and document management personnel
- CROs using laboratories to analyze clinical trial samples
- Clinical development managers and personnel
- Sponsors who have their own laboratories for analyzing clinical trial samples
- Sponsors and non-commercial sponsors
- Laboratories analyzing samples from clinical trials
- Consultants
