The Validation Manager in the Pharmaceutical Industry - Live Online Training
26/27 March 2025
Course No. 21723
Speakers
Dr. Wolfgang Schumacher
ehem. F. Hoffmann-La Roche
Dr. Norbert Skuballa
Biologische Heilmittel Heel
Lynn Bryan
Ballygan Consulting
Dr Line Lundsberg-Nielsen
NNE
All times mentioned are CET.
Objectives
For years, the topic validation/qualification has been among the top deviations in FDA‘s warning letter statistics. This is true both of pharmaceutical manufacturers and of the API industry. Other frequent citations refer to the related topics cleaning validation and change control. What is also checked during inspections – and mentioned in warning letters – is computer validation. In order to give you a broad overview of the cGMP requirements on the whole range of validation/qualification, we have designed this practice-oriented 2-day Validation Manager GMP Education Course. In many pharmaceutical and API enterprises, the Validation Manager has become an established function.
One focus will be on the FDA Guidance on Process Validation of 2011. What are differences, what are similarities to European validation Guidelines?
Target Group
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.
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