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Online workshop: Quality assurance of primary packaging for medicinal products ISO 15378:2017
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| Primary packaging is an important factor in ensuring the quality, efficacy, and safety of medicinal products. The upgrade of ISO 9001 to Good Manufacturing Practices is an important step towards improving the quality of packaging or the overall packaging manufacturing process. |
AimThe e-training will present the requirements for primary packaging for medicinal products, i.e., the specific requirements for the application of a quality management system according to the requirements of ISO 9001 in conjunction with Good Manufacturing Practices (GMP) according to the requirements of ISO 15378:2017. |
Content
- Good Manufacturing Practices according to ISO 15378 in conjunction with ISO 9001
- Introduction to concepts and definitions related to GMP
- Quality management system – general requirements, documentation
- Management responsibility
- Resource management, i.e., human resources, infrastructure, working environment
- Production processes (planning, customer-related processes, planning and development, purchasing, production, control)
- Measurement, analysis, and improvement
- DPP requirements for printed primary packaging
- Guidance on verification and validation of primary packaging
- Guidance on risk assessment for primary packaging
- Discussion of practical examples – group work
- Written exam
Work method
- The e-training will take place in a live virtual classroom.
- You will receive a link to the online training up to two days before the event.
- To participate in the online training, you will need a computer with a microphone and a camera and a reliable internet connection.
Target group
- Manufacturers of primary packaging for medicinal products.
- Manufacturers of secondary (printed) packaging for medicinal products.
- Users of primary packaging (pharmacies, pharmaceutical companies, hospitals, etc.).
- Quality management system auditors and consultants.
Additional information: Bojan Varga, phone: +386 1 477 81 08, e-mail: bojan.varga@siq.si
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