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 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.-

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,