All Adam Fleming online Events (47)

How software requirements are used in validation

January 30, 2018 from 10am to 11am – Fremont Overview:This course is NOT a programming course. We will discuss what must be done but will not discuss methods to execute necessary testing. Why should you Attend: Testing software to prove that it… Organized by Event Manager | Type: online

Products Used in Early Phase IND Studies

January 19, 2018 from 10am to 11:15am – Fremont Overview:How it may be integrated with the recommendations of the guidance documents on CMC requirements. Areas Covered in the Session:Discussion of the elements found in the guidance document for Ph… Organized by Event Manager | Type: online
Excel - Benefits and Hazards in Office 365

January 19, 2018 from 10am to 11am – Fremont Overview: In this valuable presentation, Excel expert David Ringstrom, CPA, explains how the Office 365 version of Excel 2016 differs from previous versions and perpetual licensed versions of Excel 2… Organized by Event Manager | Type: online

To Facilitate a Closed-Loop Problem Resolution System

January 17, 2018 from 10am to 11am – Fremont Overview:Defined Failure Investigation and Root Cause Analysis is a major tool in product complaint, non-conformance, and OOS failure investigations. Why should you Attend: Expectations for meaningfu… Organized by Event Manager | Type: online

Which data and systems are subject to Part 11

January 16, 2018 from 10am to 11:30am – Fremont Overview: This webinar details the regulation and how it applies to computerized systems. Learn exactly what is needed to be compliant for all three primary areas: SOPs for the IT infrastructure, ind… Organized by Event Manager | Type: online

Clinical Data Systems Regulated by FDA

January 12, 2018 from 10am to 11:30am – Fremont Overview: Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements.Certain documents, content and images related to a clinical trial must b… Organized by Event Manager | Type: online
The Value of a Human Factors Program

January 12, 2018 from 10am to 11am – Fremont Overview: This webinar will explain the implementation of ISO 62366 and the regulatory expectations discussed in the 2016 FDA Guidance for a compliant human factors/ usability program. Why should you… Organized by Event Manager | Type: online

Ensuring Data Integrity and Safety in Clinical Research

January 9, 2018 from 10am to 11am – Fremont Overview: Electronic medical records and electronic handling of study data is increasingly common. To involve computer systems in clinical research implies knowledge of 21 CFR Part 11. Why should you… Organized by Event Manager | Type: online

Act for Transportation and Logistics Professionals

January 8, 2018 from 10am to 11am – Fremont Overview:The FSMA is paradigm shift that moves the focus from food inspections to preventative measures and process compliance. Why should you Attend:Specific provisions of the FSMA that impacts tran… Organized by Event Manager | Type: online

Optimizing Process Behavior Using Design of Experiments

January 5, 2018 from 10am to 11:15am – Fremont Overview:This webinar will review the key concepts behind Design of Experiments. A strategy for utilizing sequential experiments to most efficiently understand and model a process is presented. Many… Organized by Event Manager | Type: online