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Labcompliance On-line Audio Seminar

On-line Audio Seminar 117

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)

Strategies to Implement FDA's New Quality System Guide


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On September 29, 2004, the FDA released it's first quality system guide for pharmaceutical drug cGMPs. This long awaited guidance is very important because the quality system is the only one that is always investigated during FDA inspections. And currently deviations from quality systems are frequently cited in FDA medical device inspections, and we would expect similar practices for drug GMP's. Most companies have elements of quality systems implemented but procedures may not be documented or not followed. In addition companies may not be aware on what FDA's expectations are exactly.

Key Questions related to quality systems are:

  • What are the key elements of a quality system as defined in the guidance?
  • What is the FDA looking at when they inspect quality systems?
  • How can I assess FDA's QS vs. the one we have implemented?
  • What is the difference between the GMP guidance and modern quality systems?
  • How to build an FDA compliant quality system from scratch?
  • How to leverage the new guidance for fewer and shorter FDA inspections?
  • How to leverage the new FDA guidance for fewer FDA notifications of production changes?
  • How to document a quality system?
  • How to audit or review a quality system in preparation for FDA inspections ?

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 on how to develop, implement and document an FDA compliant quality system according to the FDA guidance. 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 requirements and expectations for quality systems
  • Most frequently cited deviations related to quality systems
  • Learning from FDA's Quality System Regulation (QSR)
  • Building up a quality system from ground
  • Developing SOPs for a quality system
  • The role of management, QA, IT, and operations
  • Most important elements of a quality system
  • The importance of risk management within a quality system
  • Cost effective implementation
  • Leveraging the quality system for fewer and shorter FDA inspections
  • Leveraging the quality system for fewer FDA notifications after production changes
  • Maintaining a quality system or how to 'live' a quality system
  • How to document a quality system for the FDA
  • How to audit a quality system in preparation for FDA inspections

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

  • SOP's:
    - Developing and maintenance of SOPs
    - Training for GxP, 21 CFR Part 11 and Computer Validation
    - Change Control of Software and Computer Systems
    (as an example for change control procedures)
    - Risk Assessment for Systems Used in GxP Environments
    (as an example for risk assessment)
  • Gap Anlalysis/Checklist:
    - CGMP Quality Systems
  • How to be sure what we have and what we need?
    - FDA Compliant SOPs
  • Warning letters and Inspectional observations related to quality systems.
  • FDA regulations and guidelines related to quality systems
  • Other publications

Who should attend?

  • Management
  • QA managers and personnel
  • IT managers
  • Analysts and lab managers
  • 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.

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.-
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Recorded seminar - CD

  • Get the CD in your mail
  • Order includes all reference material.

US$ 399.-
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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.-
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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 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.