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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 322

Managing Electronic Raw Data in Regulated Environments

Definition, generation, evaluation and archiving for FDA, ICH, PIC/S and EU compliance

Recorded, available with all reference material at any time

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All regulations have strict requirements for electronic raw data and other e-records. The objective is to ensure accuracy, integrity, authenticity, security and availability of records during the entire life from generation to deletion. While the intent is the same for all regulations only FDA's 21 CFR Part 11 and the EU equivalent Annex 11 have well defined requirements but still leave a lot of room for interpretations. So the industry is more unsure than ever on what to do with the result of many FDA Warning Letters and other inspectional observations related to inadequate handling of electronic records..

Key Questions are:

  • What are FDA requirements and inspection practices for raw data in GLP/GCP/GMP?
  • What exactly are raw 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 electronic records?
  • For how long should raw data be retained?
  • In which form should raw data be retained?
  • How can I demonstrate integrity of electronic raw 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 raw 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 Part 11 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 raw data and meta data
  • FDA Inspection and enforcement practices
  • Recommendations from industry task forces
  • Definition of raw data: original records , complete records
  • Definition of 'critical' raw data and other records
  • How to ensure and demonstrate integrity of raw data
  • Managing combined electronic and paper records (hybrid systems)
  • Managing transfer of raw data from displays, e.g., balances, to computers
  • The importance of risk assessment for the management of raw data
  • Electronic record maintenance during archiving period
  • Software to manage and archive raw data and other electronic records
  • Data migration to new systems and system retirement
  • Developing a procedure for consistent raw data management
  • Examples from laboratories, offices and manufacturing

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

  • SOP: Retention and Archiving of Electronic Records
  • SOP: Recording of GLP Raw Data
  • SOP: Recording of GMP Raw Data
  • SOP: Archiving and Retrieval of GMP Data and Other Documents
  • SOP: Recording of GCP Source Data
  • SOP: Archiving and Retrieval of GCP Data and Other Documents
  • SOP: Validation of Electronic Document Management Systems
  • SOP: Validation of Commercial Off-the-Shelf System
  • SOP: Change Control of Software and Computer Systems
  • SOP: 21 CFR Part11 - Scope and Controls
  • 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 in FDA regulated environments
  • Checklist: FDA Record Retention and Retrieval
  • FDA Presentation: Data Integrity and Fraud – Another Looming Crisis?
  • Regulatory reference documents:
    - FDA Drug cGMP: Requirements for Laboratory Records
    - FDA Drug cGMP: Requirements for Manufacturing Records
    - FDA GCP Regulations: Requirements for Clinical Trial Records
  • Literature Reference papers.
    - Implementing 21 CFR Part 11 - Data Migration and Long Term Archiving for Ready Retrieval
    - Risk-based Validation of Commercial Off-the-Shelf Computer Systems
  • Warning letters and Inspectional observations related to raw data.
  • FDA guidance documents and predicate rules

Attend the seminar to learn how to ensure and document integrity, accuracy, confidentiality, availability and traceability of raw data through the entire life of the record

Who should attend?

  • All companies generating electronic records in regulated environments
  • Pharmaceutical and Device Manufacturers
  • Contract Laboratory and Manufacturing Organisations
  • Record managers
  • Documentation professionals
  • QA/QC managers and personnel
  • Analysts and lab managers
  • IT administrators
  • Validation specialists
  • Regulatory affairs
  • Human resources (HR) managers and staff
  • Training departments
  • 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