QC Laboratory Compliance and Meeting FDA Requirements

Course "QC Laboratory Compliance and Meeting FDA Requirements" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Why should you attend:
    Learn the basics of FDA law and regulations governing QC laboratories
    Laboratory organization, personnel qualification and training requirements
    Documentation and record-keeping requirements, including e-records and data integrity
    Sample integrity requirements
    Management and control of stability (shelf-life) studies
    Analytical methods verification and validation
    Management and control of laboratory instruments
    Management and control of laboratory supplies
    Proper conduct of laboratory investigations
    Consequences of laboratory non-compliance
    Discuss recent regulatory expectations
    Recent examples of FDA Warning Letter citations and other enforcement actions
    Review and discuss pain points, challenges and solutions
    Prepare for Regulatory Inspections, including FDA and Operate in a State of Readiness
    What is the difference between GMP and Non-GMP laboratories?
    What is the difference between GLP and GMP requirements for laboratories?
    What is FDA's focus during inspections?