MASTER
 

Upcoming Events

Compliance4all

How software requirements are used in validation

Fremont, CA
Overview:This course is NOT a programming course. We will discuss what must be done but will not discuss methods to execute necessary testing.

Aware of the Similarities and Differences in the files

Fremont, CA
Overview:  It will also consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes.
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Past Events

Excel - Benefits and Hazards in Office 365

Excel - Benefits and Hazards in Office 365

Fremont, CA
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 2016. Historically, each major version of Excel was identical for all users, but that's no longer ...
Friday, January 19 2018 10:00 AM 11:00 AM

Products Used in Early Phase IND Studies

Products Used in Early Phase IND Studies

Fremont, CA
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 Phase 1 materialWhat to do at really early stagesWhat about special IND studies?What about preclini...
Friday, January 19 2018 10:00 AM 11:15 AM

To Facilitate a Closed-Loop Problem Resolution System

To Facilitate a Closed-Loop Problem Resolution System

Fremont, CA
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 meaningful CAPA, supported by results-driven Failure Investigation and Root Cause Analysis, that addresses...
Wednesday, January 17 2018 10:00 AM 11:00 AM

Which data and systems are subject to Part 11

Which data and systems are subject to Part 11

Fremont, CA
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, industry standards for software product features, and the 10-step risk-based validation approach. A...
Tuesday, January 16 2018 10:00 AM 11:30 AM

Clinical Data Systems Regulated by FDA

Clinical Data Systems Regulated by FDA

Fremont, CA
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 be stored and maintained, and depending on the regulatory jurisdiction. Why should you Attend:You...
Friday, January 12 2018 10:00 AM 11:30 AM

The Value of a Human Factors Program

The Value of a Human Factors Program

Fremont, CA
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 Attend:This year FDA published their priority list for the completion of their Guidance documen...
Friday, January 12 2018 10:00 AM 11:00 AM

Ensuring Data Integrity and Safety in Clinical Research

Ensuring Data Integrity and Safety in Clinical Research

Fremont, CA
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 Attend: The increasing use of computers and increasing complexity, all persons who have any dat...
Tuesday, January 9 2018 10:00 AM 11:30 AM

Act for Transportation and Logistics Professionals

Act for Transportation and Logistics Professionals

Fremont, CA
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 transportation and 3rd party logistics providersSanitary transportation best practicesTo develop a fo...
Monday, January 8 2018 10:00 AM 11:00 AM

Optimizing Process Behavior Using Design of Experiments

Optimizing Process Behavior Using Design of Experiments

Fremont, CA
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 common types of experiments and their applications are presented. Why should you Attend:Learn a m...
Friday, January 5 2018 10:00 AM 11:15 AM

How to Validate and use Excel Requirements

How to Validate and use Excel Requirements

Fremont, CA
Overview:In this session you will learn procedures and practices on how to validate and use Excel® requirements , and how to design spreadsheets for compliance , also how to ensure and validate spreadsheet integrity. Areas Covered in the Session:How to design spreadsheets for complianceHow to en...
Thursday, December 14 2017 10:00 AM 11:15 AM
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