News

PMCF studies as a tool for generating clinical data. --- Save the Date!

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Goal-oriented, efficient and good teamwork ensures a high level of trust. Gap analysis, list of measures and concept SOP, creation of QM documents, GDP trainings, qualification IT infrastructure, GDP consultancy

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New technical article from gempex:

The outlook for the medical use of THC-containing products poses new challenges for cannabis manufacturers, as the production of a medicinal product and the associated active pharmaceutical ingredient is subject to strict...

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The IMDRF (International Medical Device Regulators Forum) has defined terms related to incidents and converted them into a nomenclature. As of 2nd March 2021, the revised IMDRF codes are available.

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May 26, 2021 - THE deadline for the medical devices industry. Also for distributors and importers new requirements apply due to EU MDR and MPDG. All changes are listed clearly and understandably in the new free white paper.

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The GMP experts invites university graduates to meet and get to know each other in order to provide information about starting a career in pharmaceutical quality assurance and the working world of GMP.

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Distributors and importers of medical devices have a lot to be prepared for with the EU MDR. What reporting requirements have been defined? What does this mean in concrete terms? How can this be implemented?

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What ist new for Combination Products? -- Changed approval process, additional control in life cycle -- Regulatory Affairs -- New technical article from gempex

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The periodical inspection of compliance is a central requirement of the GxP regulations. At PharmaTechnica, Dr. Ralf Aubeck reports on the importance of inspection readiness for pharmaceutical manufacturers and how to face US FDA audits calmly.

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A Stable QM System With Clear, Efficient Processes was Realized. QM System Upgrade, Inspection Readiness, Training and long-term GDP Compliance Consulting

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