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?