Validation/Qualification for Beginners - Live Online Training
Tuesday, 28 May 2024 9 .00 - 16.15 h
Course No. 21104
Speakers
Dr. Wolfgang Schumacher
ehem. F. Hoffmann-La Roche
All times mentioned are CEST.
Objectives
In order to give you a concentrated one-day overview of the cGMP requirements regarding Process Validation and Equipment Qualification, the ECA has designed the practice-oriented 1-day GMP Education Course “Validation/Qualification for Beginners” for you. There will be also short overviews about Cleaning Validation and the Validation of Computerised Systems.
Among other things, these questions will be discussed:
Differences between URS and FDS?
Are FAT and SAT mandatory? If not, how to use?
Do we have to follow an 8-step qualification process in in
Europe?
Is a PQ mandatory?
Is an integration of ASTM 2500 in Annex 15 requirements
possible?
How to handle Equipment Qualification with equipment in use?
Requalification – when, what, how often?
What are the differences between PQ in FDA requirements and PQ regarding Annex 15?
Are PPQ and Process Validation the same?
What are differences between Continued Process Verification (US) and Ongoing Process Verification (EU)?
Continuous Process Verification – a new concept?
Are statistics mandatory in Process Validation?
PDE – a “new” concept in Cleaning Validation
What has changed with GAMP 5 revision 2?
Analytical Method Validation on the move – ICH Q14
Background
Process Validation and equipment qualification are essential requirements in GMP. With the revisions in FDA Process Validation Guidance and the EU GMP Guide Annex 15 an Process Validation life cycle has been introduced. Risk analysis is the new “buzz word” in validation and qualification.
In the majority of GMP inspections Process Validation and Equipment Qualification aspects are covered. Although there are guidelines from the EU (Annex 15) and the FDA (Process Validation Guidance) details are still open or not well explained. Also other regulatory guidelines (WHO, ASTM…) don´t give hints in details. So, there is a lack of Interpretation.
Target Group
The addressees of the event are beginners involved in Process Validation and Equipment Qualification activities such as Subject Matter Experts for validation, heads of quality assurance, engineering department heads, etc. It also addresses members of validation teams (e.g. engineers, chemists, pharmacists, microbiologists) as well as representatives of the plant engineering department and consultants, who wants to get an insight of the Topics.
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.
Testimonials
Seminar Programme as PDF