The online training provides pharmaceutical industry executives and professionals with a concise yet comprehensive overview of the latest changes to GMP requirements.
Objectives
One might easily get the impression that the GMP world is continuously turning faster. Laws, regulations, and especially GMP requirements of the EU are constantly renewed, modernised and (allegedly) adapted against each other. The effects of the pandemic and the Brexit bring additional demands. To provide you with an overview is thus the goal of this online training course.
Programme
This Live Online Training aims at giving you a comprehensive but still compact overview about the many innovations in the GMP area – those already realised and those planned:
New Developments in the EU:
EudraLex Vol. 4
EMA Q&As
EMA Shortage Prevention Plans
Mutual Recognition Agreements
News from FDA:
Draft Guidance for Industry:
Considerations for Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products
Closure Systems for Human Drugs and Biological Products
Responding to FDA Form 483 Observations
One-Day Inspectional Assessments
Others
Outlook
Further Information
Technical Requirements We use WebEx for our live online training courses. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our trainings 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.
Fees (plus VAT) Single participation: EUR 349 for ECA Members Single participation: EUR 399 for non-ECA Members (This fee does not include the ECA Membership. You will find more about the ECA Membership at https://www.gmp-compliance.org/about-the-academy).
Group Participation Do you have colleagues who would also like to take part in the online training? Then register yourself and your colleagues together as a group. You can follow the training course either jointly (for example in a conference room) or individually at your own PCs.
Group Participation (fee per person): 3-10 Persons EUR 359,10 11-20 Persons EUR 319,20 more than 21 Persons EUR 279,30
Presentation/Certificate The presentation will be made available to you prior to the Webinar as PDF files. After the Webinar, we will automatically send you a certificate of participation.
Testimonials
