Pharma IQ Members

Dr. Nicola
Spiggelkötter

Dr. Nicola Spiggelkötter

Dr. Spiggelkötter started her career at a pharmaceutical contract manufacturer, she was responsible for the sourcing of active pharmaceutical ingredients in China and India. In this period she audited suppliers in Asia and she became experienced in international supplier qualification. Then she worked for an international Consulting company focusing on audits, inspections, trainings and quality control. Since 2009 Dr. Spiggelkötter is self-employed: Pharma consulting (special focus supply chain, transport & storage), risk management, lectures, staff training and auditing services. Frequent invited speaker at conferences, as a visiting professor she is giving lectures on pharmalogistics at an university, publications on GDP, risk management, transportation, qualification. Member of the Advisory Board of middle sized companies helping them to get through the GMP-regulated world.

Company:      Knowledge & Support
Author:         Dr. Nicola Spiggelkötter
Address:        Amselweg 6, D-38667 Bad Harzburg
Mail:             dr.spiggelkoetter@knowledge-support.info
Phone:          +49(0)5322 928561
Fax:             +49(0)5322 928522

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In this webinar, we will run through several cases where the implementation of robust, highly adaptable, and fully compliant environmental monitoring solutions drastically reduced risks of product loss and enabled compliance with strict industry regulations and guidelines.
The live webinar, hosted by industry experts Thierry Protas (Videojet) and Luc Vallancourt (Optel Vision), is the second and final webinar about data management requirements deriving from serialization regulations in Europe and the United States.
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This is the second and final webinar about data management requirements deriving from Serialization regulations in Europe and the United States. The webinars are structured around the theme "data in - data on - data out". This webinar will focus in the second part of the chain i.e. “data on” (how data is transmitted to the printer and printed as a... Read more
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Monocrotaline (MCT), a pyrrolizidine alkaloid causes liver injury in animals similar to that of hepatic venoocclusive disorder in humans. MCT induced liver injury occurs through a complex set of cellular insults involving multiple cell types which can ultimately lead to fibrotic changes.
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The high rate of attrition among clinical-stage therapies underscores the need for in vitro models that recapitulate in vivo human biology. In this webinar, we will describe the basic characterization of 3D bioprinted human liver and kidney tissues and present case studies showing their utility in modeling human toxicity and organ-specific disease... Read more
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Attendees will learn about an entirely new, fully-integrated, end-to-end temperature monitoring solution for Good Distribution Practices in the pharmaceutical supply chain.
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The development of renewable human liver models, from genetically defined origins, is likely to be a game-changing addition to the field of Predictive Toxicology. However, for these models to have significant impact they must be stable in character and capable of manufacture at scale.
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This webinar is one of two webinars about data management requirements deriving from Serialization with focus on Europe and the United States. The webinars are structured around the theme "data in - data on - data out".
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