Have a brief look at the training here (link to YouTube). All times mentioned are CEST.
With the publication of the Guidance for Industry “Process Validation: General Principles and Practices” 2011, the FDA requires a „Life Cycle Process” with 3 stages:
Continued Process Verification
The focus is on process knowledge and process understanding. Both should be a result of development and verified in routine production. The “magic” 3 batches are not mentioned any more. What is very important nowadays is the term „scientific sound“, and explicit statistics are mentioned. Six Sigma elements (e.g. Design of Experiments, DoE) are also mentioned directly or indirectly. There is also a stage in routine production called „Continued Process Verification“.
The EU Process Validation Guidelines incl Annex 15 of the EU GMP requires in a similar way a 3-stage life cycle approach to Process Validation: Pharmaceutical development, Process Validation and Ongoing Process Verification. In Europe 3 validation approaches are possible – traditional, continuous and hybrid.
How can the requirements be achieved?
How fit the FDA requirements into European guidelines and vice versa?
How can process knowledge and process understanding be demonstrated on the basis of development studies?
When is a process valid now?
Which parameters can be used for knowledge and understanding studies?
How can „Continued/Ongoing Process Verification” be realised?
These questions are at the centre of this online-Course.
Since 1987 the FDA Guideline on Process Validation has been the basis for qualification and validation. Within the FDA programme “Pharmaceutical cGMPs for the 21st Century” there was an announcement for a revision of the guideline. A FDA Policy Guide of 2004 gave some hints to the new validation approach. In November 2008 the “Guidance for Industry Process Validation: General Principles and Practices” was published as a draft and came into operation in January 2011. That is now FDA’s „current thinking“. The chapter 1 of the EU GMP Guide gives hints for more emphasises on process capabilities and varieties within process validation also in Europe. EMA´s Process Validation Guidance and also the revised Annex 15 from 2015 takes a life cycle approach to Process Validation nowadays.
The addressees of the event are qualified staff charged with or responsible for validation activities, such as commissioners for validation, heads of quality assurance, department heads, etc. It also addresses members of validation teams (e.g. engineers, chemists, pharmacists, microbiologists) as well as representatives of the plant engineering industry and Consultants.
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.
Teilnehmerstimmen - das sagen andere über unsere Seminare:
„Guter, breit gefächerter Überblick mit interessanten Verknüpfungen zur Praxis, welche die Theorie super veranschaulicht.” Marina Kicoranovic, Labor Hartmann GmbH GMP/Basis-Einstiegsschulung (B 14), September 2023
„Die Referenten waren sehr gut! Sie haben sehr klar gesprochen, nur sehr wenige englische Begriffe verwendet (super) und waren sehr praxisbezogen.” Astrid Gießler, Regierungspräsidium Karlsruhe Live Online Seminar - Basiskurs Computervalidierung & Datenintegrität im GxP Umfeld (B 3), Juni 2023
„Sehr guter Bezug zur Schulung für einen GMP-Anfänger. Habe mich sehr gut abgeholt gefühlt.” Dr. Harald Werner, Infraserv GmbH & Co. Höchst KG GMP-Basisschulung (B 1), Juni 2023