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.

On-line Audio Seminar 151

Validation and Use of MS Access™ Databases in GxP and Part11 Environments

Presenter: Tyson M. Mew, President of Ofni Systems, Inc

Recorded

Access databases are a simple way to meet many of the data collection and record keeping requirements required by the FDA but they also need to meet the technical requirements of 21 CFR Part 11, Electronic Records, Electronic Signatures. Out-of-the box Access has not been designed for regulated environments. This event will show you how to make Access databases Part 11 compliant.

Key Questions for MS Access compliance are:

• What is it we should validate?
• I have been using Access databases since years, I know that they work, why should I start to validate?
• How to overcome Access limitations for part 11?
• How does FDA's new approach for part 11 compliance impact Access databases?
• What approach should we take to validate MS Access?
• Should we test standard Access functions?
• How does electronic audit trail work with Access
• How can I sign Access records electronically?
• What and how much should we document?
• When can we delete e-records and when should we keep them?
• How to ensure database integrity for part 11 compliance?

How does the audio seminar help:

In this live audio seminar, we will review how to add the necessary controls and functionality of Part 11 to MS Access databases. The tools and techniques that will be displayed can be applied to existing databases that need compliance added right now, or can be implemented into any new databases that may be needed in your organization.

During the interactive presentation you learn about:

• GxP and Part 11 requirements related to Access databases
• Missing Access Functionality for Part 11 compliance
• How to add functionality to Access databases to make them compliant
• Different methods for implementing audit trails, security, user and password controls, and electronic signatures
• Non-technical requirements that must be implemented outside of the program
• Structure methodology and best practices for validation of Access databases
• Approach for testing databases: what and how
• Testing database output. vs. input
• Methodology for securing Access programs and data bases
• Case study: Walk through a database example and demonstrate GxP and Part 11 compliance

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

• SOPs:
  - Validation of Commercial Off-the-Shelf Computer Systems
  - Development and Maintenance of Test Scripts for Equipment Hardware, Software and Systems
  - Risk Based Validation of Software and Computer Systems
  - Part 11 Scope and Controls
  - Change Control of Software and Computer systems
  - Validation Of Spreadsheet Applications-
  - Configuration management and version control of software
• Templates/Examples
  - Identification of computer systems
  - Identification of network infrastructure and systems
• Reference paper:
  Risk based validation of Commercial Off-the-shelf Computer Systems
• FDA 483 inspectional observations and warning letters with deviations related to software and computers
• FDA regulations and guidelines related to computer validation
• And more....

Who should attend?

• All developers and users of MS Access databases
• Validation specialists
• QA managers and personnel
• Production and lab managers
• Regulatory affairs
• Training department
• Documentation department
• Consultants

How to order

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

Recorded seminar - Web download 'Site' offer 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$ 349.-
Recorded seminar - CD Get the CD in your mail Order includes all reference material.	US$ 349.-
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$ 249.-

About audio seminars

 

Online audio seminars are presented over the phone. During the live presentation attendees can:

1. Study the printed slide material
2. Watch the slides on a computer
3. Watch the slides on a video screen in a seminar room
4. Ask questions through email and web form

 

About Dr. Ludwig Huber

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

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