Labcompliance On-line Audio Seminar

On-line Audio Seminar 134

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)

FDA Compliant Electronic Records Management

Requirements, Strategies and Tools for Implementation

Recorded

Electronic records are more and more replacing paper records to demonstrate compliance with regulations. Advantages are more convenient search capabilities, easier communication across different sites and last but not least smaller storage volumes. While FDA regulated companies are quite familiar with compliance of paper records, there are many questions related to electronic records, especially when using more recent communication technologies, such as e-mails..

Key Questions related to electronic records management are:

What are current and future US FDA requirements for electronic records?
Are there different requirements in Europe or Asia?
What are inspectors looking for?
How to archive electronic formats: standard files or proprietary formats?
How to define raw data and meta data?
What should be contents of a retention policy?
We scan paper documents for easier search, can we destroy the paper?
We transcribe paper records into a computer, do we need to keep the paper?
We plan to purchase an electronic records management system, what should we care about?
What should we care about when we migrate to a new computer system
We want to use e-mails to communicate regulated activities, what should we care about?
What should I care about when I sign electronic documents?

How does the audio seminar help:

Answers will be presented by Dr. Ludwig Huber in a new interactive audio seminar. During the one hour seminar, the speaker will present strategies and give concise practical recommendations. More than 10 SOPs, templates and examples will help immediate and cost effective implementation.

During the interactive presentation you learn about:

FDA requirements for electronic records
International requirements: Europe, Japan
Industry recommendations: GAMP, ISO 15489
Type of records to be maintained and archived
The lifecycle of electronic records
Options to sign electronic documents
Converting paper into electronic records:
Developing a strategy and procedures for electronic records
Using e-mails for regulated activities
Best practices for long term archival and retrieval
Ensure and demonstrate integrity of electronic records
Considerations for Electronic Document Management Systems
Migration of records to new systems
Record maintenance during archiving
Case studies

And for easy and instant implementation:
download 10+ documents from special seminar website

SOP: Retention and Archiving of Electronic Records
SOP: Validation of Electronic Document Management Systems
SOP: Scanning of Paper Records for GxP Compliant Archiving
SOP: Retirement of Computer Systems
SOP: Data back-up and Restore
SOP: Validation of Commercial Off-the-Shelf System
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 Systems
Warning letters and Inspectional observations related to electronic records.
FDA guidance documents and predicate rules

Who should attend?

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

About Dr. Ludwig Huber

Dr. Ludwig Huber is worldwide director for FDA compliance at Agilent Technologies and author of the Labcompliance Newsletter. He has been conducting over 100 web and audio or video based seminars since ten years.

He 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 visits FDA in Rockville, VA, and participates in panel discussions with FDA professionals. For more information, click here.

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.

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 over the phone
Ask questions through web forms

Attendees can discuss and ask questions over the phone, fax or e-mail.

The transcript and questions and answers have been be posted at the seminar website. This includes questions that came through e-mail and life during the seminar.

How to order

Pick one of the options in the table that fits your needs.

Recorded seminar - Standard (Instant download)
Single person, includes all reference material From the convenience of your desk	US$ 249.-

Recorded seminar - Site offer (instant download)
Multiple persons - single site Meet in a seminar or conference room or share the audio file and reference material at your site	US$ 349.-

CD - Recorded audio seminar
Get the CD in your mail Useful if you can/could not attend the on-line seminar. Order includes all reference material.	US$ 349.-

Recorded Seminar plus reference material - Special offer for Labcompliance User Club Members)
(for user club information and registration, click here)	US$ 149.-

Best Practices

all included in the seminar handout - and more!!!

Audio Seminars