Arjan Langen
GE Healthcare
Referent:innen
Zielsetzung
Risk-based approaches have considerably gained importance in all branches in recent years. Pharmaceutical production, quality assurance and quality control would be unthinkable without them.
Starting with the FDA initiative “cGMPs for the 21st Century” for the introduction of the risk-based approach, through the subsequent ICHQ9 guideline on risk management, which can now be found as Part III of the EU GMP guidelines, to the revised Annex 15 with a wealth of risk analyses, these principles are anchored everywhere. With the revision of Annex 1, risk management is also increasingly becoming part of the main guideline for the manufacture of sterile pharmaceutical products.
In this Live Online Training on the principles, regulations and application of risk assessment in the context of contamination control, you will gain insight into the relevant underlying guidelines and guides as well as valuable pointers for practical implementation using practical examples. The following areas are covered:
Starting with the FDA initiative “cGMPs for the 21st Century” for the introduction of the risk-based approach, through the subsequent ICHQ9 guideline on risk management, which can now be found as Part III of the EU GMP guidelines, to the revised Annex 15 with a wealth of risk analyses, these principles are anchored everywhere. With the revision of Annex 1, risk management is also increasingly becoming part of the main guideline for the manufacture of sterile pharmaceutical products.
In this Live Online Training on the principles, regulations and application of risk assessment in the context of contamination control, you will gain insight into the relevant underlying guidelines and guides as well as valuable pointers for practical implementation using practical examples. The following areas are covered:
- General introduction on risk assessments
- ICH Q8, Q9 and Q10 principles
- How to apply risk assessments in contamination control
- Example of a Contamination Control Strategy
- Interactive session: FMEA
Zielgruppe
The course is designed for personnel of pharmaceutical companies, their suppliers and representatives of authorities with responsibilities in:
- Contamination Control
- Aseptic Manufacturing
- Quality Assurance
- Quality Control
- Internal Quality Audits
- External Inspections
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.
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
Introduction and Organisationals
General Introduction on Risk Assessments
General Introduction on Risk Assessments
- Principles of ICH Q9
- Patient safety and product quality
- Dos and don’ts
- Tools and methods
ICH Q8, Q9 and Q10 Principles
- Quality by Design (QbD)
- Criticality of quality attributes and process parameters
- Control strategy life cycle
- Knowledge management
How to Apply Risk Assessments in Contamination Control
- Pro-active vs. reactive
- FMEA for equipment and processes
- Risk assessments for impact assessments
- HACCP for contamination control
Example of a Contamination Control Strategy
- Contamination control master file
- Reference document
- Annual report
Short Interactive Session (participants do an FMEA on a certain topic)
- Executing an FMEA (on a sterilizer or isolator)
- Evaluation – what went well and what were the challenges?
Recording from 29 September 2022
Duration of Recording: 3h 20min
| ECA-Member*: | € 890,- |
| Regular Fee*: | € 990,- |
| EU/GMP Inspectorates*: | € 445,- |
| APIC Member Discount*: | € 950,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
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