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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 267

Raw Data in FDA Regulated Environments

FDA/EU compliant recording, maintenance and archiving

Recorded, available with the reference material at any time

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No or incomplete recording and archiving of raw data are amongst the most frequently cited deviations in recent warning letters. '"Electronic raw data not saved", "Audit trails failed to provide the reason for changing the raw data", "Firm needs to have a system for accountability for raw data", and "Insufficient recording of raw data", are just a few examples. And this despite of the fact and 'Raw Data" are well defined in FDA and international regulations and most companies have procedures.

Key Questions related to raw data are:

  • What are FDA requirements and inspection practices for raw data in GLP/GCP/GMP?
  • What is the new definition of EU GMP for raw data?
  • What exactly are computer generated raw data: original electronic data, first human readable data, computer print-outs?
  • Which data should be retained and archived?
  • What should we care about when we change data: on paper, in electronic form?
  • We transcribe original observations from paper to a computer data base. Can we delete the original paper records?
  • In which form should raw data be retained: paper, standard electronic files, proprietary electronic formats?
  • Can I delete the electronic records after I have printed and signed the electronic records?
  • For how long should raw data be retained?
  • How can I demonstrate integrity of raw data?
  • How important is risk assessment for my decisions?
  • We move to a new computer systems that can not handle old data - What to do?
  • 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 electronic raw data and if so for how long

How does the audio seminar help:

Answers will be presented by Dr. Ludwig Huber in a new interactive audio seminar. During the seminar, 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.

During the interactive presentation you learn about:

  • FDA Requirements for raw data and meta data: acquisition, maintenance, archiving
  • FDA Inspection and enforcement practices
  • EU GMP's new definition and requirements for raw data
  • Definition of raw data: original records vs. standard electronic formats, paper print-outs
  • Recording of raw data: manual, automated
  • Ensure and demonstrate integrity of raw data for Part 11 and Annex 11 compliance6
  • Changing raw data: on paper, in electronic form
  • Copying raw data: paper to paper, paper to electronic form, electronic to paper
  • 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
  • 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

  • PowerPoint Presentation
  • Script
  • SOP: Recording of GLP Raw Data
  • SOP: Archiving of GLP Data and Other Documents
  • SOP: Retention and Archiving of Electronic Records
  • SOP: Validation of Electronic Document Management Systems
  • SOP: 21 CFR Part11 - Scope and Controls
  • SOP: Recording of GMP Raw Data
  • SOP: Archiving and Retrieval of GMP Data and Other Documents
  • SOP: Scanning of Paper Documents for GxP Compliant Electronic Archiving
  • Checklist: Using computers in FDA regulated environments
  • Regulatory reference documents:
    - FDA Drug cGMP: Requirements for Laboratory Records
    - Requirements for Clinical Trial Records
    - FDA Drug cGMP: Requirements for Manufacturing 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
  • NARA: Records Management Guidance for Agencies Implementing Electronic Signatures
  • Warning letters and Inspectional observations related to raw data.
  • FDA and International guidance documents and predicate rules

Who should attend?

  • Record managers
  • Documentation professionals
  • QA managers and personnel
  • Analysts and lab managers
  • Validation specialists
  • Regulatory affairs
  • Human resources (HR) managers and staff
  • Training departments
  • Consultants

Date, time and duration

Order at any time, replay at any time, download the reference material at any time.

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.