Live Online Training - Risk Assessment in Contamination Control
Course No 18207
Costs
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Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org
Speakers
Arjan Langen, Director Sterility Assurance, GE Healthcare, The Netherlands
Objectives
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 the new online course 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 the new online course 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
Target Group
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 Requirements
For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.
At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
Programme
09.00 – 09.15 h
Introduction and Organisationals
09.15 – 10.00 h
General Introduction on Risk Assessments
Introduction and Organisationals
09.15 – 10.00 h
General Introduction on Risk Assessments
- Principles of ICH Q9
- Patient safety and product quality
- Dos and don’ts
- Tools and methods
10.00 – 10.45 h
ICH Q8, Q9 and Q10 Principles
ICH Q8, Q9 and Q10 Principles
- Quality by Design (QbD)
- Criticality of quality attributes and process parameters
- Control strategy life cycle
- Knowledge management
10.45 – 11.00 h Break
11.00 – 12.00 h
How to Apply Risk Assessments in Contamination Control
11.00 – 12.00 h
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
12.00 – 13.00 h Break
13.00 – 13.30 h
Example of a Contamination Control Strategy
13.00 – 13.30 h
Example of a Contamination Control Strategy
- Contamination control master file
- Reference document
- Annual report
13.30 – 14.30 h
Short Interactive Session (participants do an FMEA on a certain topic)
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?
14.30 – 14.45 h Break
14.45 – 15.30 h
Evaluation and Conclusion / Q&A Session
14.45 – 15.30 h
Evaluation and Conclusion / Q&A Session
GMP Conferences by Topics
- Quality Assurance
- GMP in Biotechnology
- Microbiology
- Regulatory Affairs
- GMP in Pharmaceutical Development
- Quality Control
- GDP
- Sterile / Aseptic Manufacturing
- Computer Validation
- Validation
- Technical Operations
- GMP for APIs and Excipients
- Medical Devices
- GMP Basic Training Courses
- Packaging
- Data Integrity