All Events in DoubleTree by Hilton Philadelphia Airport (16)

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

The Use of Drug Master Files & Quality Agreements: Understanding and Meeting your Regulatory and Processing Responsibilities

May 31, 2018 at 9am to June 1, 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

Seminar on Software Risk Management in Philadelphia

September 24, 2018 at 9am to September 25, 2018 at 6pm – DoubleTree by Hilton Philadelphia Airport Description: The seminar will address the specific challenges software poses for the risk management process. Basic risk management concepts will be introduced and then applied to software specific a… Organized by NetZealous LLC DBA GlobalCompliancePanel | Type: seminar

Validation and 21 CFR Part 11 Compliance of Computer Systems

October 4, 2018 at 9am to October 12, 2018 at 6pm – DoubleTree by Hilton Philadelphia Airport Course "Validation and 21 CFR Part 11 Compliance of Computer Systems" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.… Organized by NetZealous DBA as GlobalCompliancePanel | Type: seminar

Uncovering and Managing Successful Post Market Compliance for Medical Devices

October 25, 2018 at 9am to October 26, 2018 at 6pm – DoubleTree by Hilton Philadelphia Airport Course "Uncovering and Managing Successful Post Market Compliance for Medical Devices" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon… Organized by NetZealous DBA as GlobalCompliancePanel | Type: seminar

Introduction to Adaptive Design for Clinical Trials

November 15, 2018 at 9am to November 16, 2018 at 6pm – DoubleTree by Hilton Philadelphia Airport Description: This 2-day seminar includes an overview of Adaptive Design, and an emphasis in group sequential design, sample size re-estimation, and Phase II/III Adaptive Seamless Designs. The role of… Organized by John Robinson | Type: seminar

Applied Statistics for FDA Process Validation 2019

January 15, 2019 at 9am to January 16, 2019 at 6pm – DoubleTree by Hilton Philadelphia Airport 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 through comme… Organized by John Robinson | Type: seminar