Live Online Training: Ongoing/Continued Process Verification
Im Auftrag der ECA

Live Online Training: Ongoing/Continued Process Verification Im Auftrag der ECA

Seminar Nr. 18330

 

Kosten

ECA-Member: EUR 690,--
Non ECA Member: EUR 990,--
EU/GMP Inspectorates: EUR 495,--
APIC Member Discount: EUR 890,--

Alle Preise zzgl. MwSt.

Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Sprecher

Gert Moelgaard, Moelgaard Consulting
Dr Thomas Schneppe, Bayer Bitterfeld GmbH

Zielsetzung

Ongoing/Continued Process Verification is a new regulatory expectation in both Europe and USA. It replaces the traditional validation approach and regular revalidation  because it is a life-long activity which is done as long as a pharmaceutical product is manufactured and sold commercially.
 
This course introduces the Ongoing/Continued Process Verification regulations, the background and some examples of practical implementation of Ongoing/ ContinuedProcess Verification programs. It  covers the US FDA requirements vs. the European requirements and the link to the Product Quality Review (PQR).
 
Last but not least the course covers Continuous Process Verification and links to automation system requirements for the future.

Hintergrund

With the new paradigm for process validation that came with the updated EU GMP Annex 15 from 2015 and FDA’s Process Validation Guide from 2011 pharmaceutical companies are expected to have a program of Ongoing/Continued Process Verification for all their GMP regulated products, including the legacy products that has been produced for many years. There should be a link between the OPV/ CPV program and the Product Quality Review and they should both include a continuous improvement approach in order to understand and control the quality of the pharmaceutical product better as the manufacturing experience is build.
 
This has become a general regulatory expectation and most companies have implemented OPV/CPV programs including the ongoing evaluation of the process performance, the sources of variations and the appropriate statistical tools for the process performance evaluation in order to better understand and control the process and thus the product quality.

Since the new regulations in Europe and US there has been a significant increase in the number of regulatory observations and warning letters related to insufficient process validation and lack of understanding of the modern principles of process validation that the new regulatory expectations have established.

Zielgruppe

The addressees of the event are qualified staff charged with or responsible for validation activities, especially regarding stage 3 (Continued/Ongoing Process Verification) of the process validation life cycle.  We mean commissioners for validation, heads of quality assurance, department heads, etc. It also addresses members of validation teams (e.g. chemists, pharmacists, microbiologists) as well as staff who is involved in process monitoring activities and consultants.

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

Setting the scene/FDA´s current thinking
  • Qualification and Validation Paradigm Shift
  • The process validation regulations from EMA and FDA
  • Process Design, Control Strategy and Validation
  • Process Validation Life Cycle Approach
  • Ongoing vs. Continued Process Verification
  • Ongoing Process Verification and Product Quality Review
Case Study: How to implement Continued Process Verification of a legacy process      
  • Role of SOP in the company QM System
  • How to deal with the established 3 batch approach?
  • Key aspects (Preconditions, Stages 1-3, Review)
  • Further deliverables from the data and link to other on sites regulations/procedures
  • Challenges
  • Experiences
  • Lessons learnt
Ongoing Process Verification Examples
  • Process Validation Life Cycle Introduction
  • Ongoing Process Verification (OPV) basics
  • OPV example for a QbD product
  • OPV example for an existing (legacy) product
  • OPV monitoring and control
  • Product Quality Review with OPV
Ongoing Process Verification and the future role of PAT, industrial IT and Automation
  • OPV and cGMP for the 21th Century
  • Continued/ongoing and continuous process verification
  • Continuous manufacturing examples
  • Continuous process verification examples
  • Preparing for the future…

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