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April 12, 2018 at 9am to April 13, 2018 at 6pm – DoubleTree by Hilton Philadelphia Airport Overview: This seminar will explain the implementation of ISO 62366 and the regulatory expectations discussed in the 2016 FDA Guidance for a compliant human factors/ usability program. Location: Phi… Organized by John Robinson | Type: seminar
April 12, 2018 at 9am to April 13, 2018 at 6pm – DoubleTree by Hilton Philadelphia Airport Overview: This combined DMF (Drug Master Files) and Quality Agreement training will discuss the advantages for suppliers and drug product manufacturers in developing these arrangements together. Over… Organized by John Robinson | Type: seminar
April 12, 2018 at 9am to April 13, 2018 at 6pm – DoubleTree by Hilton Philadelphia Airport Why should you attend: Good clinical data management (CDM) is paramount for a successful research. After all, Garbage In, Garbage Out (GIGO). CDM is involved in all aspects of collecting, processing,… Organized by John Robinson | Type: seminar
April 12, 2018 at 9am to April 13, 2018 at 6pm – DoubleTree by Hilton Philadelphia Airport Overview: Supplier qualification and assessment is required in both the QSR regulations and ISO standards. Many companies spend a great deal of time and money in pursuit of compliance. Many companies… Organized by John Robinson | Type: seminar
May 17, 2018 at 9am to May 18, 2018 at 6pm – DoubleTree by Hilton Philadelphia Airport Overview: In Guidance for Industry Process Validation: General Principle and Practices, process validation is defined as, ""...the collection and evaluation of data, from the process design stage thr… Organized by John Robinson | Type: seminar
May 17, 2018 at 9am to May 18, 2018 at 4:30pm – DoubleTree by Hilton Philadelphia Airport Overview: If you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue. Advertising and promotion for devices is weak and lacks legal clarity. For dru… Organized by John Robinson | Type: seminar
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