Isolation technology: challenge and compliance to the new Annex 1. FREE WEBINAR
- 3 October 2023
- Online
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English
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Training overview
The Road to Pharma Microbiology Congress 2023 presents:
Isolation technology: challenge and compliance to the new Annex 1
Sponsored by IMA
The approval in August 2022 of the new EU GMP Annex 1 has formalized several innovative concepts and requirements for sterility assurance and defined a new standard for the design of RABS, isolators and related machines used in aseptic fill-finish processes. The presentation analyses the requirements inside the new Annex that impact on the isolation technology area. The goal is to explain how isolators and RABSs can maximize compliance and, at the same time, guarantee process flexibility and plant productivity. The most critical design and process aspects will be analysed, such as requests relating to “first air” protection, management of direct and indirect contact part and RTU material introduction. The discussion covers case studies with traditional liquid or freeze-dried productions or toxic/biohazard scenarios where sterility assurance must necessarily be cross-referenced with the problems relating to high containment.
The ROAD TO PHARMA MICROBIOLOGY CONGRESS 2023 is a series of FREE WEBINARS that will accompany us till the Pharma Microbiology Congress 2023 in November. Discover all the free webinars by clicking here!
Only subscribers with business company email address will be admitted to the webinar!
Key points of the training
- The ROAD TO PHARMA MICROBIOLOGY CONGRESS 2023 is a series of FREE WEBINARS that will accompany us till the Pharma Microbiology Congress 2023 in November.
SCHEDULED TIME: 11.30 am– 12.30 pm (CET)
The webinar is aimed specifically at Pharma, Biotech and Medical Device Companies, Regulatory bodies and Technology Suppliers involved in the manufacturing and control of Sterile medicines.
The course will be carried out through live lectures. Practical examples will be showcased, providing delegates with real life examples to be applied in their daily job life.
For online trainings the access link will be sent 2-3 days before the start of the training.
5% discount for registrations within 1 month before the start of the training, 10% discount for registrations within 2 months before the start of the training. VAT not included. Please inquire for discounts for multiple registrations. Discounts are not cumulative.
Cancellation terms
In order to cancel enrolment to an event, please email info@pharmaeducationcenter.it within 2 weeks before the starting date of the event. Once this term will be expired, the entire fee will be charged.
Participant replacement
It is possible to replace a participant attendance without additional cost, simply by contacting info@pharmaeducationcenter.it. It is asked to notify the participant replacement request within 5 days before the starting date of the course/event, specifying the full name and surname of the enrolled participant as well as the full name and surname of the substitute.
Training cancellation
If the minimum number of participants is not reached, Pharma Education Center reserves the right to cancel or schedule the event for another date. Formal communication will be given within 5 days before the event date. In this case Pharma Education Center will refund the registration fee in full and without additional charges. Alternatively, the participant can request a spendable coupon for participating in another PEC event scheduled in the current year.
Speakers
Giacomo Guidi
IMA
R&D Isolation Technologies
Register now
Training materials available for attendees
Certificate of attendance
Senior trainers with hands-on experience
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