Understanding of Laboratory control system as mentioned in System Based Inspection Guidances and how to use Laboratory control system to evaluate your laboratory.
Why Should You Attend:Recent FDA 483 Inspection Reports and Warning Letters include many observations that demonstrate that there is a focus on compliance in the laboratory. FDA Investigators evaluate compliance to the CGMPs based on inspectional guidance outlined in two Compliance Policy Guides that provide the basis for system based inspections. One of the six systems defined in these inspectional guidances is the Laboratory Control System. The Laboratory Control System, as defined in these guidances establish the current FDA interpretation of programs that should be in place.
Who Will Benefit:
The following individuals or disciplines will benefit from attending this Webinar:
- Quality Control Managers
- Quality Control Supervisors
- Quality Control Analysts
- Quality Control Record Reviewers
- Quality Assurance Managers
- Quality Assurance Supervisors
- Quality Assurance Record Reviewers
