Ongoing/Continued Process Verification (Part 1) - Monitoring and Trending of Process Data with control charts – basic control charts
Tuesday, 12 January 2021 14.00 - 15.30 h
Course No. 18317
Speakers
Dr. Raphael Bar
BR Consulting
Important: Deadline is 12 noon on 11 January 2021
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.
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
This training/webinar cannot be booked. Send us your inquiry by using the following contact form.
To find alternative dates for this training/webinar or similar events please see the complete list of all events.
For many training courses and webinars, there are also recordings you can order and watch any time. Just take a look at the complete list of all recordings.
Testimonials
Seminar Programme as PDF