Important: Deadline is 12 noon on 11 January 2021
Sprecher
Dr Raphael Bar, BR Consulting, Israel
Hintergrund
The EU GMP and FDA regulatory documents require manufacturers to monitor product quality to ensure that a state of control is maintained throughout the lifecycle of new products and legacy products during the third process validation stage called Continued Process Verification (CPV) or Ongoing Process Verification (OPV). Indeed, regulatory agencies expect manufacturers to implement a CPV plan as reflected in FDA warning letters.
Statistical Process Control (SPC), whereby process data are plotted in process behavior charts and evaluated against statistically derived control, allows the detection of unusual variation, trends or shifts, that indicate, in turn, a deviation from a state of control.
Zielgruppe
Employees from companies, who are involved in pharmaceutical process validation activities (developers, QM, manufacturing, heads of validation departments, etc.) especially regarding stage 3 ongoing/continued process verification, are addressed.
Technical Requirements
For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
Programm
The following issues will be discussed:
- What is Ongoing/Continued Process Verification
- Run Chart versus Control Chart
- Process Variation
- What is “state of statistical control”
- Control charts of grouped and individual data
- Computation of three-sigma Control limits
- Three-Way Charts
- Examples of control charts
- Capability indices (Cp, Cpk, Pp and Pk)
- Stability and capability of a process
Remark: Part 2 of this webinar on the following day deals with Monitoring and Trending of Process Data – SPC rules in the real world for a CPV/OPV plan
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