- Datum:
-
- Webinar
GMP Pre-sterilized Packaging Material - Live Online Training
- Veranstaltungsort:
- online
- Veranstalter:
- CONCEPT HEIDELBERG GmbH
GMP Aspects / Implications of the New Annex 1
- Regulatory expectations
- What´s new in Annex 1? (relevant aspects for packaging materials)
- Requirements for supplier qualification of pre-sterilized packaging material manufacturers
- Issues in inspections
Selection of a Sterilization Method
- Type of Packaging Materials
- Different Sterilization Methods
- EtO-Alternatives
- Pros and Cons
Packaging Design and Management of Pre-sterilized Packaging Material
- Design Aspects – What need to be considered?
- How to handle packaging materials for aseptic processing
Q&A Session 1
Validation of a Sterilization Procedure
- Critical Process Parameters (CPPs)
- Validation Strategy
- Validation of loading patterns
- Revalidation
A Suppliers‘ Perspective on EU GMP Annex I Requirements
- A Suppliers‘ Perspective on EU GMP Annex I Requirements
- Appropriate primary packaging components and adequate primary packaging material selection
- How can this support pharmaceutical companies in complying with the respective requirements laid out in EU GMP Annex I?
Decontamination of Pre-Sterilized Containers (including Case Study)
- What is the ideal process for transferring ready-to-use (RTU) vials into the fill & finish area of an isolator?
- Effects of Vaporized Hydrogen Peroxide (VHP) on pre-sterilized glass and plastic vials
- VHP as a technology for proper outer decontamination of RTU packaging material
Q&A Session 2
CONCEPT HEIDELBERG GmbH
Rischerstraße 8
69123 Heidelberg
Deutschland
Telefon: +49 6221 844415
Telefax: +49 6221 844464
eMail: info@concept-heidelberg.de
Internet: http://www.gmp-navigator.com/
