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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 116

Audits of Computer Systems in Laboratories and Manufacturing


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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 ineffective.

Key Questions related to audits are:

  • What do FDA and other regulations say about auditing computer systems?
  • What exactly are the expectations of inspectors?
  • What to do if the inspector asks for the internal audit report?
  • 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, summary?
  • 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

  • SOPs:
    - Auditing Computer Systems
    - Validation of Commercial off-the-Shelf Computer Systems

  • Worksheet: Laboratory Audits

  • Expert presentation:
    "Ready for a Computerized System Validation Audit", presentation from David

  • Bergeson, former FDA expert for computer validation

  • 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
  • Consultant.

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 and Laboratories

For Validation and Part 11 Compliance in Pharmaceutical and Device Industries

Click here

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 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.