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
On-line Audio Seminar 116
Audits of Computer Systems in Laboratories
Auditing of computer systems is important to verify compliance of the systems
with regulations and internal standards. When done right, audits can help to
improve quality of computer system operation and uptime. In addition audits are
also an excellent tool to prepare your organization and staff for external
audits, e.g., FDA inspection. For example, the Pharmaceutical Inspection
Convention Scheme (PIC/S) has developed a 10 page computer system audit for
inspectors which is ideally suited to understand what inspectors are looked for.
However, without an auditing strategy audits can become quite complex and
Key Questions related to audits are:
- What do FDA and other regulations say about auditing
- What exactly are the expectations of inspectors?
- What to do if the inspector asks for the internal audit
- How to develop an efficient and compliant auditing program?
- What approach should we take for auditing?
- How to conduct an audit?
- What are the most critical audit items?
- What are most frequently found deviations?
- How should I document auditing results - level of detail,
- What is the frequency of audits?
- What should we show the FDA inspectors?
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. After the
seminar, an extensive list of reference material like SOPs,
templates, gap analyses and examples will help immediate and cost
effective development and implementation of an audit program.
During the interactive presentation you learn about:
- Regulatory requirements: FDA, EU
- Audit rcommendations from the new FDA Quality System
guidance for cGMPs
- Developing an SOP for audits of computer systems.
- Assigning responsibilities
- Conducting the audit: : review procedures, walk through the
computer system area
- Most critical questions to ask
- Documenting detailed audit findings
- The audit summary report
- Effective follow up
- Presenting evidence of the audit to the FDA
And for easy and instant implementation:
download 10+ documents from special seminar website
- Auditing Computer Systems
- Validation of Commercial off-the-Shelf Computer Systems
Worksheet: Laboratory Audits
"Ready for a Computerized System Validation Audit", presentation
Bergeson, former FDA expert for computer
FDA Compliance Policy Guide: FDA Access to
Results of Quality Assurance Program Audits and Inspections
FDA and other guidelines related to computer
system validation and audits
Warning letters and Inspectional observations
related to computers.
Who should attend?
- Internal auditors
- QA managers and personnel
- Lab and manufacturing managers
- Validation specialists
- Regulatory affairs
- Human resources (HR) managers and staff
- Training departments
- Documentation department
How to order
Pick one of the options in the table that fits your needs.
Replaced by the more recent seminar
Auditing Computer Systems in Manufacturing
For Validation and Part
11 Compliance in Pharmaceutical and Device Industries
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
||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,