Friday, April 6, 2018

Why Analytical Method Validation is Required - Course 2018

April 5, 2018 at 9am to April 6, 2018 at 6pm – The DoubleTree Baltimore-BWI Airport Overview: Following the initial development, the steps further continues thru optimization and subsequently to Validation, leading to the understanding of Validation Parameters and their generic defi… Organized by John Robinson | Type: seminar
What is the Purpose of a Quality Management System Seminar 2018

April 5, 2018 at 9am to April 6, 2018 at 6pm – The DoubleTree Baltimore-BWI Airport Overview: Using lecture, discussion, and exercises, this 2 day seminar will focus on taking your QMS from surviving to thriving. We'll move from understanding the regulatory requirements, how to crea… Organized by John Robinson | Type: seminar
eCTD Submissions 2018 - Common Technical Document Guidelines

April 5, 2018 at 9am to April 6, 2018 at 6pm – The DoubleTree Baltimore-BWI Airport Overview: The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic product into a common format (called the CTD - Common Technical Document) has imp… Organized by John Robinson | Type: seminar
Understanding in Vitro-in Vivo Correlations Seminar 2018

April 5, 2018 at 9am to April 6, 2018 at 6pm – The DoubleTree Baltimore-BWI Airport Overview: Let us start with a simple question, why would anyone need an IVIVC and prediction of plasma drug levels. The simple answer is that it is the only scientific tool available to the formulato… Organized by John Robinson | Type: seminar
What is TIN Matching Course 2018

April 5, 2018 at 9am to April 6, 2018 at 6pm – Courtyard Arlington Crystal City/Reagan National Airport Overview: For years the IRS has struggled with the independent contractor, the non-resident alien worker, US citizens with foreign financial accounts and tax collection. They have placed the burden o… Organized by John Robinson | Type: seminar
Medical Device Single Audit Program Preparation

April 6, 2018 from 10am to 11am – Online Overview:The International Medical Device Regulators Forum (IMDRF) recognizes that a global approach to auditing and monitoring the manufacturing of medical devices could improve their safety and ove… Organized by Adam Fleming | Type: online
Quality Audit According to Gxp-GMP Requirements 2018

April 6, 2018 from 10am to 11:30am – Online Overview:GMP regulations describe required quality management system for production and testing of products in these regulated industries. The purpose of the GMP regulations is to ensure that a produ… Organized by Adam Fleming | Type: online
Compliance for Electronic Records and Signatures 2018

April 6, 2018 from 10am to 11:30am – Online Overview:This webinar demystifies Part 11, and get you on the right track for using electronic records and signatures to greatly increase productivity. Areas Covered in the Session:Which data and sys… Organized by Adam Fleming | Type: online