Important: Deadline is 12 noon on 12 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.
The implementation of Stage 3 is translated into establishing an ongoing CPV/OPV program which allows Identification of CPV Signals and defining types of responses to these signals. However, applying traditional SPC (Statistical Process Control) rules my lead to false signal alarms. Thus, collecting, charting and evaluating product and process data under relaxed and adjusted SPC rules allow a practical and streamlined implementation of the CPV/OPV program.
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
In part 2 of the webinar series, you will learn:
- Tools for detecting a trend and shift in process average and/or process variability
- The problem of too many statistical false signals
- Are all statistical assumptions valid in real-world process data?
- Which statistical rules can be relaxed?
- Control charts with practical limits
- Examples of process behaviour charts
- Building a CPV/OPV Plan
- Identification of CPV Signals
- Types of responses to signals
Remark: Part 1 of this webinar on the day before deals with Monitoring and Trending of Process Data with control charts – basic control charts
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