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
On-line Audio Seminar 158
Raw Data in FDA/EU Regulated Environments
Compliant recording, maintenance and
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 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
- 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 the raw data and if so for how
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,
- FDA Inspection and enforcement practices
- 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
- 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
- Electronic record maintenance during archiving period
- Software to manage and archive raw data and other electronic
- 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
- 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
- Checklist: Using computers in FDA regulated environments
- Regulatory reference documents:
- FDA Drug cGMP: Requirements for Laboratory 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
- NARA: Records Management Guidance for Agencies Implementing
- Warning letters and Inspectional observations related to raw
- 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
How to order
Replaced by the more recent seminar
Raw Data in FDA Regulated
FDA/EU compliant recording,
maintenance and archiving
About audio seminars
Online audio seminars are presented over the
phone. During the live presentation attendees can:
- Study the printed slide material
- Watch the slides on a computer
- Watch the slides on a video screen in a seminar room
- 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
||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,