The new Annex 1: Have you already implemented it? 4 part-series
At the end of August, the requirements of the complete revised Annex 1 must be implemented under EU GMP. Our webinars provide a comprehensive overview of the most important requirements. Furthermore, there are practical tips explained and suggestions for the implementation of the "contamination control strategy", probably the most significant change in the new version. In the last part of the webinar, many examples for the preparation of the CCS will also be presented. Fritz Röder has been involved in the development of Annex 1 for years and has expertise in sterile manufacturing and the evaluation of GMP aspects.
What does Fritz Röder offer in his webinar?
- Incorporating inspector responses to Annex 1 and implementation concepts.
- Practical implementation of the inspection strategy and GAP analysis, with information on all individual chapters
- Experiences from the implementation of Annex 1 - what works, what does not work?
- Significantly more information and explanations of many details, assistance in interpreting complicated passages
- Revision of the topics "Barrier Systems" and "Handling of Gloves
Content of the four-part webinar:
Part 1
Duration: ca. 90 Minutes
- Introduction
- QRM / control strategy
- Buildings ("Premises")
- Ventilation
- Production layouts
Part 2
Duration: ca. 90 Minutes
- Barrier systems
- Equipment
- Cleaning validation / biodecontamination
- Water and steam
- Compressed air and product-wetted gases
Part 3
Duration: ca. 90 Minutes
- Production
- Optional control
- Sterilisation, disinfection
- Aseptic handling
- Filtration & PUPSIT, Single-Use Systems
Part 4
Duration: ca. 90 Minutes
- Monitoring and QC / Exit Monitoring
- Aseptic Process Simulation
- Practical implementation of the control strategy (examples)
- Practical tips
- Proposal for structuring of the CCS
Duration in total approx. 6 hours
Presentation Language: English | Slides: English
...more about your speaker Fritz Röder...
Webinars allow you to conveniently attend training sessions and technical presentations from anywhere at any time. They are the perfect way to keep up to date with the latest knowledge without much effort. You are also welcome to ask the speaker questions after the webinar.
Note on quota call-off: When booking this webinar-series described here, four units will be deducted per participant.
For whole teams we offer attractive special prices with special advantages or develop your own in-house training for you - please contact us.
# Online intensive training
- Fritz Röder
Merck KgaA
E-Learning | Streaming im MP4 Format
Prizes & Conditions of Participation
per person plus VAT. - Payment upon receipt of invoice.
The fee includes for a single booking:
- the one-time viewing of the booked webinar/ or webinar series by the person(s) named to us in advance.
- the receipt of the slides shown as a printable PDF file.
The training is personal and, if booked individually, is for personal training purposes only - not for an entire team. We thank you for your fairness.
Cancellation or change of person is not possible after sending the handout (live: usually 1-2 days before the event | recording: immediately).
Full terms and conditions and participant information can be found here.
Consent to photographs and film recordings as well as their publication: We would like to point out that photographs and film recordings are taken during our events by persons or service providers commissioned and authorised by us for the documentation of our events (legal basis Art. 6 para. 1 lit. f DSGVO). The recordings serve our public relations work as well as the use, publication and distribution in print, digital and online media, such as newsletters, websites, brochures, flyers and social networks. In this context, it is pointed out in particular that photos and videos on the internet can be accessed by any person. It cannot be ruled out that such persons will continue to use the photos/videos or pass them on to other persons. By registering for and participating in the event, you agree that the organiser is permitted to publish photos, audio and/or film contributions taken at the event without restriction, including for advertising purposes, across all media without permission or remuneration. You have the right to revoke this consent at any time. The revocation of consent does not affect the lawfulness of the processing carried out on the basis of the consent until the revocation. This means that consent can be revoked with effect for the future. We will then immediately remove your photo/video from our website. In this case, please send your revocation to info(at)alphatopivs.de, stating the event.
Special prices for team bookings:
If the training is of interest to a group of colleagues, please contact us. Here we offer special group prices for you as a company. The group size is limited to a maximum of 30 participants per webinar. You can participate live or stream the webinar at an individual later time in our video library.
You are interested in a live event but don't have time on the scheduled day of the live webinar?
Then simply ignore the reminder emails about the live event. Our webinar platform will register that you were not present. As soon as the webinar has taken place, you will automatically receive an email from us a few hours later with your personal link to stream the webinar. You can then watch the webinar - individually - whenever your schedule allows. If you have any questions about the content, you are welcome to send them later to fragen@alphatopics(dot)de.
Note on contingent retrieval:
When booking via your company contingent, please note the separate note in the description of the webinar as to how many parts will be deducted from your contingent for the selected webinar, or webinar series.
Save money by booking a quota of 10 and combine any 10 individual webinars (90 min. each) from the topics offered.
Price: 2,500.- € per contingent plus VAT.