Labcompliance On-line Audio Seminar
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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

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.
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US$ 399.-

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Recorded seminar -
CD
- Get the CD in your mail
- Order includes all reference material.
|
US$ 399.-

|
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:
- 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
agencies.
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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.