Ongoing/Continued Process Verification (Part 1) - Monitoring and Trending of Process Data with control charts – basic control charts

Ongoing/Continued Process Verification (Part 1) - Monitoring and Trending of Process Data with  control charts – basic control charts

Course No 18317

Important: Deadline is 12 noon on 11 January 2021

Costs

ECA-Member: EUR 249,--
Non ECA Member: EUR 299,--

(All prices excl. VAT)

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Dr Raphael Bar, BR Consulting, Israel

Background

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.

Target Group

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.

Programme

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

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