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)Learn from the convenience of your desk or with your colleagues in a seminar room
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On-line Audio Seminar 211

Auditing Computer Systems for FDA and EU Compliance

For Validation and Part 11 Compliance in Pharmaceutical and Device Industries

Recorded

Current FDA inspection focus is on computer systems. Just in the last two years more than 20 warning letters mentioned deviations for computer systems, some of them with disastrous consequences for the companies. Most companies have a computer validation and Part11 compliance program, but either it is wrongly designed, not implemented or not followed. When done right internal audits of computer systems can not only avoid FDA 483's and warning letters but also make make computer validation much more efficient. However, there are many questions related to auditing computers systems.

Key Questions related to auditing computer systems are:

 

• What is FDA's inspections approach for computer systems?
• What are inspectors looking at?
• What are the most frequently found deviations?
• How far into the history can audits go?
• How to develop an efficient and compliant auditing program?
• How to prepare staff for internal and external audits of computer systems?
• Which type of records should be available: computer print-outs, electronic records
• How should I document auditing results - level of detail, summary?
• What is the frequency of audits?
• How to proof data integrity?
• Can FDA inspectors asks for the internal audit reports?

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 and examples will help immediate and cost effective implementation.

During the interactive presentation you learn about:

• FDA regulations and guidelines
• 10 most frequently found deviations and how to avoid them
• Developing an SOP for audits of computer systems.
• Effective development and use of audit checklists
• Assigning audit responsibilities
• Conducting the audit: : review procedures, walk through the computer system area
• Most critical questions to ask
• Auditing for data integrity
• Documenting detailed audit findings
• The audit summary report
• Auditing for Part 11 and Annex 11 compliance
• Effective follow up
• Presenting evidence of the audit to the FDA
• Case study: going through a life audit

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
  - Gap Analysis for Computer Systems
• Examples
  - List with Required Procedures for Computer Validation
  - List with Required Records for Computer Validation
• Checklist:
  - Using computers in FDA regulated environments
• Form: Documenting audit findings
• 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
• 15 Warning letters and Inspectional observations related to computers.
  All from the last three years.
• Five Pages PIC/S Regulatory Checklist for Inspectors: Using Computers
• FDA Presentations
  -  Edwin Rivera: Data Integrity and Fraud - Another Looming Crisis?
  - George Smith: Update on Part 11
  - George Smith: Risk based computer system validation
  - Steve Wilson: FDA Regulatory Perspective on Data Integrity
• Expert presentation:
  "Ready for a Computerized System Validation Audit", presentation from David Bergeson, former FDA expert for computer validation

Who should attend?

• IT managers and staff
• QA managers and personnel
• Operations managers
• Users of computer systems in regulated areas
• Analysts and lab managers
• Validation specialists
• Training departments
• Documentation department
• Consultants

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.-

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.