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FDA Presentation:
Data Integrity and Fraud - An Other looming Crisis

Warning letters and Inspectional observations related to raw data and other electronic records

Labcompliance On-line Audio Seminar

This seminar has been recorded and is available on CD and for instant download. All reference material as listed below and more is available on a special seminar website. The website is regularly updated with most recent information. In case there are questions related to the topic, they can be submitted through a web form and will be answered by the speaker. For ordering info click here
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On-line Audio Seminar 328

Understanding FDA's New Guidance on Electronic Source Data in Clinical Investigations

With tool kit for cost effective implementation

Recorded, available with all reference material at any time

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The FDA just released the new final guidance on using electronic source data in clinical investigations. This document replaces the guidance of the same name from November 2012. The content of the new guidance is significantly different from the previous ones. It reflects FDA's ongoing concern on electronic records because FDA is well aware on how easy it is to change electronic records and the FDA has cited several manufacturers for falsifying source data. Therefore as a major focus of the guidance the FDA calls for "Adequate controls to ensure confidence in the reliability, quality, and integrity of the electronic source data.". Even though the FDA has addressed some of the industry concerns related to draft version the final guidance leaves still room for intepretations.

Key Questions are:

  • What are "adequate controls" to ensure confidence in the reliability, quality, and integrity of the electronic source data?
  • What are FDA requirements and inspection practices for electronic source data
  • What exactly are source data: original electronic data, first human readable data, computer print-outs?
  • Which data should be retained and archived?
  • Can I delete the electronic records after I have printed and signed the paper records?
  • Can I delete paper records after data have been entered into a computer system
  • For how long should source data be retained?
  • In which form should source data be retained?
  • How can I demonstrate integrity of electronic source data?
  • How important is risk assessment for my decision?
  • We move to a new computer systems that can not handle old data - What to do?
  • I transcribe data from paper into an data base. Can I scrap the paper?
  • I scan paper print-outs and store PDF files in a data base - can I delete the paper records?
  • Should I be able to reprocess the electronic source data and if so for how long?

How does the this audio seminar help:

Answers will be presented by Dr. Ludwig Huber in a new interactive audio seminar. Using FDA's new guidance as a model, the speaker will present strategies and give practical recommendations and examples. After the seminar, an extensive list of reference material like SOPs, worksheets, templates and examples will help immediate and cost effective implementation of the principles and strategies for other regulations.

During the interactive presentation you learn about:

  • FDA and EU requirements for electronic source data
  • FDA Inspection and enforcement practices: examples for warning letters
  • History, scope and intended use of the new guidance
  • Key points of the new FDA guidance
  • Major differences to earlier draft guidances
  • Definition of source data: original records , complete records
  • Requirements for electronic data
  • Going through the process from data capture to FDA submission
  • How to ensure and demonstrate integrity of source data
  • Capturing data through manual entry and transmisson from devices
  • Managing combined electronic and paper records (hybrid systems)
  • Changing eCRFs: Who and how to document
  • Electronic record maintenance during the archiving period
  • Responsibilities of sponsors and clinical sites
  • Developing a procedure for consistent source data management
  • Applications: Electronic case reports (eCRF), medical images, lab reports, diaries

And for easy and instant implementation:
download 10+ documents from special seminar website

  • SOP: Retention and Archiving of Electronic Records
  • SOP: Recording of GCP Source Data
  • SOP: Archiving and Retrieval of GCP Data and Other Documents
  • SOP: Responsibilities of Sponsors and Clinical Sites for Computerized Systems
  • SOP: Validation of Electronic Document Management Systems
  • SOP: Scanning of Paper Records for GxP Compliant Archiving
  • SOP: Electronic Audit Trail - Specification, Implementation, Validation
  • SOP: Review of Electronic Audit Trail
  • Checklist: Using Computers for Clinical Trials
  • Checklist: FDA Record Retention and Retrieval
  • FDA Presentations:
    - Data Integrity and Fraud – Another Looming Crisis?
    - Electronic Source Documentation in Clinical Investigations
  • Regulatory reference documents:
    - FDA GCP Regulations: Requirements for Clinical Trial Records
  •  Warning letters and Inspectional observations related to electronic
      source data and other electronic records
  • FDA guidance documents
    - Electronic Source Data in Clinical Investigations
    - Computerized Systems Used in Clinical Investigations

Attend the seminar to learn how to ensure and document integrity, security, confidentiality, availability and traceability of e-source data through the entire life of the record

Who should attend?

  • (Bio)pharmaceutical and medical device industry
  • Sponsors and (clinical) contract organizations
  • System owners
  • Validation specialists
  • IT specialists
  • QA managers and personnel
  • Archivists
  • Users of software and computer systems
  • Regulatory affairs
  • Training department
  • Documentation department
  • Consultants

Date, time and duration

Recorded seminar, available at any time with all reference material

How to order

Pick one of the options in the table that fits your needs.

Recorded seminar - Web Download

  • Multiple persons - single site
  • Learn at your desk, meet in a seminar or conference room or share the audio file and reference material at your site.
  • Order includes all reference material.

US$ 399.-
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Recorded seminar - CD

  • Get the CD in your mail
  • Order includes all reference material.

US$ 399.-
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Special offer for Labcompliance Usersclub Members
Recorded Seminar- CD or Web download.

  • Order includes all reference material.
  • for Usersclub information and registration, click here

US$ 299.-
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About audio seminars

Online audio seminars are presented over the phone. During the live presentation attendees can:

  1. Study the printed slide material
  2. Watch the slides on a computer
  3. Watch the slides on a video screen in a seminar room
  4. Ask questions through email and web form

About Dr. Ludwig Huber

Dr. Ludwig Huber is the editor and author of Labcompliance. He has been conducting over 300 web and audio or video based seminars since 15 years and and he has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This included seminars, workshops and presentations for the US FDA, SFDA, KFDA, HSA, ISPE, PDA, PIC/S and several national health agencies.

Dr. Ludwig Huber is a frequent presenter at IVT conferences and has been awarded as the 'Presenter of the Year' out of 170 speakers. This photo is from IVT's conference on Network Qualification with Ludwig Huber as plenary speaker.

Dr. Huber has published several books related to validation and compliance, for example: Validation of Computerized Analytical and Networked Systems. He was or still is a member of several committees, e.g., of the GAMP® Special interest group (SIG) on Laboratory Computers, PDA Part 11 task force, IVT task force on network infrastructure qualification and the European Compliance Academy. He frequently visited FDA in Rockville, VA, and participated in panel discussions with FDA professionals. For feedback from attendees of seminars and  for other information on Dr. Ludwig Huber, click here.

Ludwig Huber in Panel Discussions with FDA Officials

George Smith, FDA's national Part11 expert, at a panel discussion with Ludwig Huber during an IVT conference

Smith and Huber discussed and answered questions about computer system validation and e-records.
Ludwig Huber (right) and John Murray, FDA's Computer Validation Expert, (left), speaking at the IVT Computer System Validation Conference.
Mr. Murray explained FDA's next steps for Part 11