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

Recorded

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

About Dr. Ludwig Huber

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

He 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.

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.

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 over the phone
Ask questions through web forms

Attendees can discuss and ask questions over the phone, fax or e-mail.

The transcript and questions and answers have been be posted at the seminar website. This includes questions that came through e-mail and life during the seminar.

How to order

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

Recorded seminar - Standard (Instant download)
Single person, includes all reference material From the convenience of your desk	US$ 249.-

Recorded seminar - Site offer (instant download)
Multiple persons - single site Meet in a seminar or conference room or share the audio file and reference material at your site	US$ 349.-

CD - Recorded audio seminar
Get the CD in your mail Useful if you can/could not attend the on-line seminar. Order includes all reference material.	US$ 349.-

Recorded Seminar plus reference material - Special offer for Labcompliance User Club Members)
(for user club information and registration, click here)	US$ 149.-

Best Practices

all included in the seminar handout - and more!!!

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