The Fundamentals of an Effective and Compliant Thermal Validation
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Thermal validation is a critical part of ensuring that temperature-controlled units are consistently reliable and accurate. Incorrect validation can lead to harsh regulatory consequences and harm the end consumer.
Unfortunately, many pharma professionals find thermal validation overwhelming as very little practical guidance is available in the regulations. The actual pragmatic implementation of the guidelines can be heavily based on experience with the regulatory bodies.
Jakob, the speaker at this webinar, has designed it specifically to take the mystery out of regulatory requirements and deliver concise information on meeting the regulators’ expectations.
Jakob Konradsen has extensive experience in thermal validation projects- from temperature-controlled units to large-scale warehouses and transport vehicles. He works with companies to ensure thermal compliance to their internal and regulatory requirements, constantly adapting a risk-based approach.
This webinar will give you a great understanding of the fundamentals of thermal validation. We will also provide examples of practical implementation of the different elements, ensuring you comply with the regulatory requirements.
By the end of the webinar, you will better understand the requirements set forth by the regulatory bodies and have better confidence in choosing a thermal validation strategy.
Who Should Attend:
Quality professionals and anyone who is working with temperature-controlled units. Be it smaller temperature chambers, fridges, and freezers, to more giant warehouses that wish to learn how to prepare, perform and document thermal validation activities, or better understand the different elements.
- Skill Level: Novice, Intermediate
1.1 Regulatory requirements and guidelines
- FDA requirements
2.1 The structure of a mapping/documents
- User requirements
- Mapping protocol
- Mapping execution
- Mapping report
3.1 Making the mapping protocol
- Defining the requirements
- Planning the mapping
- Risk-based approach
4.1 Real-life examples of implementing a risk-based approach to mapping strategy
- Process risks
- Compliance risks
- Technical risks
Jakob KonradsenCo-founder and Head of Quality at Eupry
Jakob Konradsen has a background in electrical engineering and has worked with quality and validation for his entire work life. Jakob has broad experience within the thermal validation and calibration field, emphasizing temperature validation of everything from temperature-controlled units to large-scale warehouses and transport vehicles. Jakob is passionate about finding solutions that balance regulatory requirements with a cost-effective and pragmatic approach and a risk-based approach.
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