Proper Documentation and SOPs to Ensure Laboratory Compliance
This presentation will review the regulations, citations, and typical procedures found in laboratory operations and then propose a way to build better documentation.What laboratory documentation is required for complianceWhat are typical citations as it relates to laboratory documentationWith forethought and design, good procedures are possible Good documentation and record integrity ensure good complianceAreas CoveredLaws, Regulations and guidance applicable to laboratory operationsIt’s not just about meet the regulations, it’s getting the processes to achieve business needsProcess mapping approach to designing a sample executable laboratory operations SOPSteps necessary to ensure existing laboratory and new laboratories have processes implemented that ensure complianceCourse Level - Beginner to AdvancedWho Should AttendLaboratory Operations ManagementQuality Assurance ManagementDesigners of Laboratories.Why Should You AttendThe goal of laboratory documentation should be to ensure compliance. However, failures in documentation and procedures represent more than half of the top citations by FDA. FDA is telling us we just don’t get it. As such we must look at what does proper documentation look like.
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This presentation will review the regulations, citations, and typical procedures found in laboratory operations and then propose a way to build better documentation.
- What laboratory documentation is required for compliance
- What are typical citations as it relates to laboratory documentation
- With forethought and design, good procedures are possible
- Good documentation and record integrity ensure good compliance
Areas Covered
- Laws, Regulations and guidance applicable to laboratory operations
- It’s not just about meet the regulations, it’s getting the processes to achieve business needs
- Process mapping approach to designing a sample executable laboratory operations SOP
- Steps necessary to ensure existing laboratory and new laboratories have processes implemented that ensure compliance
Course Level - Beginner to Advanced
Who Should Attend
- Laboratory Operations Management
- Quality Assurance Management
- Designers of Laboratories.
Why Should You Attend
The goal of laboratory documentation should be to ensure compliance. However, failures in documentation and procedures represent more than half of the top citations by FDA. FDA is telling us we just don’t get it. As such we must look at what does proper documentation look like.
