Building a Compliant Laboratory – From Foundation to Business Excellence
Compliance in laboratory settings has been a topic for the FDA and other regulators for decades. With the increased focus on data integrity and continued focus on laboratory investigations, it is critical more than ever to ensure you have designed your laboratory operations system to meet the compliance needs of your business. In this presentation, I will define compliance, provide a translation of regulations and guidance into user requirements and then using those user requirements to show how one can design a laboratory system. Finally, I will provide a roadmap for implementation whether an existing laboratory or a new laboratory.Compare what Compliance means in the Pharmaceutical, Biotechnology, and Medical Device Laboratory and how that differs from Business ExcellenceUnderstanding how to translate the thou shalt of regulatory guidance and stakeholder needs into user requirements and then into system execution steps Understanding stakeholders needs and translating requirements into the design to achieve business excellenceProcess mapping approach to designing the laboratory operations systema. Organize the processes into meaningful systemsb. Evaluate for efficiencyc. Develop Performance Metricsd. Create a process map for each systeme. Identify key linkages to other systems – augment mapsf. Develop the map into standard operating proceduresPresentation of a Process map for one laboratory operations system Receive a sample SOP for laboratory operation that can be translated to your operationAreas 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 management. Quality Assurance Management. Designers of laboratories.Why Should You AttendEveryone struggles with getting their laboratory into compliance. Learn how to build a compliant laboratory from starting with a good foundation to implementing for Business Excellence. Dr. Husman’s presentation will walk you through the process and steps needed to ensure a compliant laboratory is built or rebuilt for business excellence.
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Compliance in laboratory settings has been a topic for the FDA and other regulators for decades. With the increased focus on data integrity and continued focus on laboratory investigations, it is critical more than ever to ensure you have designed your laboratory operations system to meet the compliance needs of your business. In this presentation, I will define compliance, provide a translation of regulations and guidance into user requirements and then using those user requirements to show how one can design a laboratory system. Finally, I will provide a
roadmap for implementation whether an existing laboratory or a new laboratory.
- Compare what Compliance means in the Pharmaceutical, Biotechnology, and Medical Device Laboratory and how that differs from Business Excellence
- Understanding how to translate the thou shalt of regulatory guidance and stakeholder needs into user requirements and then into system execution steps
- Understanding stakeholders needs and translating requirements into the design to achieve business excellence
- Process mapping approach to designing the laboratory operations system
a. Organize the processes into meaningful systems
b. Evaluate for efficiency
c. Develop Performance Metrics
d. Create a process map for each system
e. Identify key linkages to other systems – augment maps
f. Develop the map into standard operating procedures - Presentation of a Process map for one laboratory operations system
- Receive a sample SOP for laboratory operation that can be translated to your operation
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
Everyone struggles with getting their laboratory into compliance. Learn how to build a compliant laboratory from starting with a good foundation to implementing for Business Excellence. Dr. Husman’s presentation will walk you through the process and steps needed to ensure a compliant laboratory is built or rebuilt for business excellence.
