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July 17, 2014 at 9am to July 18, 2014 at 6pm – DoubleTree by Hilton Hotel Philadelphia Center City Overview: This course provides a comprehensive understanding of the FDA Combination Product system. Participants receive a foundation of knowledge about the FDA Office of Combination Products, the FD… Organized by GlobalCompliancePanel | Type: seminar, pharma, medical, clinical, health, compliance, regulatory, fda
July 15, 2014 from 10am to 11am – Online Event Overview: Development, implementation, and maintenance of an ISO 13485-compliant quality management system requires many resources and personnel to meet with success.ISO 13485 is a wordy standard, dr… Organized by GlobalCompliancePanel | Type: seminar, pharma, medical, clinical, health, compliance, regulatory, fda
July 10, 2014 from 10am to 11:15am – Online Event Overview: The webinar explains what is needed to prepare for an audit or regulatory inspection. It addresses SOPs for the GxP and IT infrastructure, hardware and software qualification, computer syst… Organized by GlobalCompliancePanel | Type: seminar, pharma, medical, clinical, health, compliance, regulatory, fda
July 10, 2014 from 9am to 6pm – Courtyard Boston Logan Airport Overview: FDA inspections are typically the starting point for the sequence of enforcement actions, since serious violations discovered at inspections will often result in Warning Letters, which in t… Organized by GlobalCompliancePanel | Type: seminar, pharma, medical, clinical, health, compliance, regulatory, fda
July 8, 2014 from 10am to 11:30am – Online Event Overview: An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket… Organized by GlobalCompliancePanel | Type: seminar, pharma, medical, clinical, health, compliance, regulatory, fda
July 8, 2014 from 10am to 11:30am – Online Event Overview: Water system microbial excursions are the bane of laboratories, utility operations, and production, often causing huge expenditures of labor for system sanitization and additional testing a… Organized by GlobalCompliancePanel | Type: seminar, pharma, medical, clinical, health, compliance, regulatory, fda
July 8, 2014 from 10am to 11am – Online Event Overview: HACCP elements of the Codex Alimentarius required by GFSI auditing schemes. The process by which the HACCP program is tested.HACCP validation and verification is an often neglected area of… Organized by GlobalCompliancePanel | Type: seminar, pharma, medical, clinical, health, compliance, regulatory, fda
July 3, 2014 from 10am to 11:15am – Online Event Overview: FDA continues to enforce Part 11 through its ongoing Part 11 inspection and enforcement program. Just in the last 12 months FDA issued more than 10 warning letters with citations Part 11 vi… Organized by GlobalCompliancePanel | Type: seminar, pharma, medical, clinical, health, compliance, regulatory, fda
July 3, 2014 at 9am to July 4, 2014 at 6pm – Mandarin Orchard Singapore Overview: This session will discuss key considerations for Good Documentation Practices that would impact product quality, safety, and efficacy and/or data integrity. Key components of documentation… Organized by GlobalCompliancePanel | Type: seminar, pharma, medical, clinical, health, compliance, regulatory, fda
July 2, 2014 from 10am to 11:30am – Online Event Overview: There is a pervasive public perception that the FDA has been ineffective in protecting the public. Recent news events seem to support this perception. The FDA is working hard to change that… Organized by GlobalCompliancePanel | Type: seminar, pharma, medical, clinical, health, compliance, regulatory, fda
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