Labcompliance On-line Audio Seminar
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available on CD and for instant download. All reference material as
listed below and more is available on a special seminar website. The
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On-line Audio Seminar 360
Managing Electronic Raw Data in Regulated
Environments
Definition, generation, evaluation and
archiving for FDA, PIC/S and EU compliance
Recorded, available with all reference material
at any time

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/PICS equivalent Annex 11 have well defined requirements but
still leave a lot of room for interpretations. Even worse FDA and EMA are
focusing on integrity of electronic records during inspections. So the
industry is more unsure than ever on what to do with the result of many recent
Warning Letters and inspectional observations related to inadequate handling of
electronic records..
Key Questions are:
- What are FDA requirements and current 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/PICS requirements for raw data and meta data
- Recent FDA Inspection and enforcement practices
- Recommendations from industry task forces
- Definition of raw data: original records , complete records
- How to ensure integrity of raw data during the entire
records life
- 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 Organizations
- 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.-

|
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.
|
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.
Dr. 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 explined FDA'snext steps for Part 11
|
 |
Ludwig Huber (right) in a panel discussion with FDA
inspectors and directors:
Dr. Robert C. Horan, B Erik Henrikson,Joseph Famulare, and
Nicholas Buhay, |