Thursday, May 17, 2018

Process Validation General Principle and Practices - Philadelphia 2018

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
Promotion & Advertising Practices 2018 under FDA Observation

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
New EU Medical Device Regulation | Updated Regulation 2018

May 17, 2018 at 9am to May 18, 2018 at 6pm – Hilton Zurich Airport Overview: Regulation proposals of the European Commission Background In 2012, the Commission adopted a package of measures on innovation in health. The package consisted of a Communication and two re… Organized by John Robinson | Type: seminar
Root Cause Analysis: Foundation of Investigations and CAPA

May 17, 2018 at 9am to May 18, 2018 at 5pm – DoubleTree by Hilton Philadelphia Airport Overview: Why you should attend: What do the regulations say? Four Phases of RCA Promote the ability to provide problem-solving support in situations where one is not an expert in the process or tec… Organized by John Robinson | Type: seminar
Clinical Data Management - Benefits of Standardization in Establishing CDM Processes

May 17, 2018 at 9pm to May 18, 2018 at 6am – DoubleTree by Hilton Philadelphia Airport Overview: When new drugs or devices are tested in humans, the data generated by, and related to, these trials is known as clinical data. This data represents a huge investment by the biopharmaceutica… Organized by John Robinson | Type: seminar