Referent:innen
Dr Ingolf Stückrath
Sanofi-Aventis Deutschland
Dr Line Lundsberg-Nielsen
NNE
Dr Franz Schönfeld
Regierung von Oberfranken
Sarah Zimmet
Boehringer Ingelheim
All times mentioned are CEST.
Zielsetzung
With the Guidance for Industry “Process Validation: General Principles and Practices”, the FDA requires a new direction. Validation is now a „Life Cycle Process” with 3 stages:
- Process Design
- Process Qualification
- Continued Process Verification
The stage 3 “Continued Process Verification” is a new step in validation. Also legacy process should be (re)validated regarding this life cycle. The start is stage 3 “Continued Process Verification”. The goal of the third validation stage is continual assurance that the process remains in a state of control (the validated state) during commercial manufacture. A system or systems for detecting unplanned departures from the process as designed is essential to accomplish this goal, says the Guidance. Now, also the EU requires Ongoing Process Verification as part of a Validation Life Cycle.
But how to implement Continued/Ongoing Process Verification in the routine production – beginning from the definition of the Control Strategy to the Product Quality Review / Annual Product Review?
- What is state of the art regarding systems for detecting unplanned departures from the process?
- How to handle the monitoring at Stage 3 (Continued/Ongoing Process Verification)?
- What are the differences between Continued Process Verification (FDA), Continuous Process Verification
- (ICH Q8) and Ongoing Process Verification (EU)?
- Are there parallels regarding Medical Devices?
- What statistic parameters could help?
- Is a statistician necessary?
- How is OPV/CPV linked to PQR/APR?
- What are the expectations of an EU Inspector?
These questions are discussed, and the possibilities for implementation are covered.
Hintergrund
Since 1987 the FDA Guideline on Process Validation has been the basis for qualification and validation. A new FDA Policy Guide of 2004 gives some hints as to the new validation approach. In January 2011 the new “Guidance for Industry Process Validation: General Principles and Practices” was published as final guidance. That is now FDA’s „current thinking“. EMA’s new Process Validation Guidance also mentions a Life Cycle Approach for Process Validation. And with the citation of ICH Q8, the possibility to do Continuous Process Verification is also mentioned. In the Annex 15 revision document, valid since 1 October 2015, also a Continued Process Verification, called Ongoing Process Verification, is now a requirement.
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.
Date & Technical Requirements
Date
Tuesday, 27 May 2025, 09.00 - 16.45 h
Wednesday, 28 May 2025, 08.30 - 16.30 h
Technical Requirements
We use Webex for our live online training courses and webinars. At www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
Programm
Gesamtes Programm als PDF herunterladen
Overview: The new process validation guides from FDA and EMA and the new industry guides from ISPE, PDA and ECA: content and principles
- How the concept of Process Validation is about to change
- Comparison of Annex 15 revision with FDA Process Validation Guidance
- Real-life examples
Ongoing Process Verification – View of an EU Inspector
- EU Process Validation Lifecycle approach (overview)
- EU GMP requirements on EU-OPV
- Authorities expectations reg. PQR and link to OPV
- Comparison of EU and US requirements reg. OPV/CPV
Case Study: From Control Strategy to Trending
- Introduction in Biopharmaceutical Processes
- Process development and definition of parameters
- Parameters and control
- Control Strategy
- Process Performance Validation Approach
- Statistical Process Control
Case Study: Large Molecules - Process Validation and Statistical Trending in Biopharmaceutical Manufacturing
- Basic Statistics
- Content of CPV protocol/report
- Trending program and related procedures
- Evaluation of Trends and CAPAs
- Link to APR/PQR
- Link to IT Systems
Medical Device and Pharmaceuticals: Similar Expectations and Approaches
- Leveraging experience
- Quality System similarities
- Standard Approaches – foundation for implementation
Recent trends in FDA inspections, observations and warning letters
- Examples of expectations and enforcement
- Regulatory enforcement trends related to observations and Warning Letters
SPC as tool for Continued Process Verification
- Continued Process Verification: Requirements
- Case Study Sanofi-Aventis
Case Study: How to implement CPV of a Legacy Process
- Challenges
- Experiences
- Lessons learnt
The future role of PAT, industrial IT and Automation in Continued Process Verification: Implementing a Control Strategy
- Control strategy and implications for automation solutions
- Bridging islands of information systems in manufacturing
- From data to information to knowledge: getting gold out of data
- Continued process verification: monitoring challenges
- Window to the Quality: The future role of automation and IT systems in manufacturing?
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This course is part of the GMP Certification Programme "ECA Certified Validation Manager"
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