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.
In this webinar we will discuss the Laboratory Control System, as identified in the System Based Inspection guidances. Discussion will be based on the five components of any system: Men, Materials, Machines, Methods, and Measurements, and how the inspectional guidance relates to each of these components.
Areas Covered in the Seminar:

• Regulations and Guidances that will be covered (FDA, EU, Canada, WHO, ICH, other).
• US- 21CFR211.160 , CPGM 7356.002 , CPGM 7345.848.
• Why the FDA uses a Systems approach to inspections.
• The six systems.
• The Laboratory Control System.
• Procedures, Records and Practices – The basics for all programs.
• Laboratory Control System Components.
• Using the Laboratory Control System to evaluate your laboratory.

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