Dr Ana Kuschel
West Pharmaceutical Services
Referent:innen
Aaron Mertens
STERIS
Markus Heinz
Syntegon
Dr Rainer Kahlich
GMP/GDP Inspector
Sergio Cuevas Luján
Boehringer Ingelheim
Bernd Zeiss
Gerresheimer
Zielsetzung
In this online course, you will learn which requirements apply for pre-sterilized packaging material (e.g., ready-to-use, readyto- sterilize). You get to know all aspects of the GMP manufacture of pre-sterilized products (e.g., vials, stoppers) that influence the the quality of the final product. In addition, practice-oriented presentations and case studies will guide you through the relevant requirements on qualification / validation, and controls for pre-sterilized materials, including impact of the new EU GMP Annex 1.
Hintergrund
Currently there is a growing demand in the development of presterilized packaging materials (e.g. ready-to-sterilize, ready-touse) for several enhanced Biotech applications. However, new GMP requirements for the sterile packaging material (e.g. regarding validation of the sterilization procedure) apply with the revised EU GMP Annex 1 entitled “Manufacture of Sterile Medicinal Products”, which provides guidance on the approaches to sterilization of products, equipment and packaging components. All sterilization processes should be validated.
Annex 1, Scope: The manufacture of sterile products covers a wide range of sterile product types (active substance, excipient, primary packaging material and finished dosage form).
This online training course will therefore deal with the current discussions and trends in the manufacture of GMP pre-sterilized packaging materials: GMP requirements for sterilization of packaging materials
- GMP requirements for sterilization of packaging materials / devices
- Selection of a suitable sterilization method
- Critical process parameters (CPPs) that should be considered in qualification and / or routine processing
- Validation strategy
- Requirements for suppliers
Validated loading patterns should be established for all sterilization processes and load patterns should be subject to periodic revalidation. Maximum and minimum loads should also be considered as part of the overall load validation strategy. The validity of the sterilizing process should be reviewed and verified at scheduled intervals based on risk.
The presentations will be provided in a practice-oriented way from the different viewpoints of authorities, suppliers of packaging materials / devices / services (including sterilization activities), and the pharmaceutical industry.
Zielgruppe
This online event is designed for employees working in the pharmaceutical industry (including drug device combination products), for suppliers of packaging materials & devices and to all who have to deal with the manufacture, control and release of packaging materials for aseptic processing. They key areas are
- Sterile Production
- Packaging material / Device development
- Manufacturing / Processing / Assembling
- Quality Control
- Quality Assurance
Technical Details
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate:
The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.
Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate:
The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.
Programm
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
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
Recording from 14 November 2024
Duration of the recording: approx. 5h 9min
Duration of the recording: approx. 5h 9min
| ECA-Member*: | € 1090,- |
| Regular Fee*: | € 1190,- |
| EU/GMP Inspectorates*: | € 595,- |
| APIC Member Discount*: | € 1140,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
Weitere Termine online
Weitere Termine online nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Packaging Manager"
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E-Mail: info@concept-heidelberg.de
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