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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 129

Risk Management for FDA/EU Regulated Industries

Introduction and Strategies for Compliance and Trouble-free Operations


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The FDA has been mandating risk management for medical devices since 1996 through the Quality System Regulation (QSR) 21 CFR Part 820. Risk assessment is also a key element of FDA's 21st century drug cGMP initiative and of the new approach for 21 CFR Part 11. The FDA started risk based system inspections and also issued warning letters related to risk management. There is a lot of guidance from organizations such as ISO, ICH, NIST, GAMP and GHTF but the industry is unsure how to best initiate and implement a risk management program that not only complies with FDA/EU expectations but also help to reduce costs and ensures a trouble free operation.

Key Questions related to risk management are:

  • What are FDA requirements and inspection practices related to risk management?
  • Which sites will the FDA most likely inspect?
  • What are inspection practices for high/medium/low risk facilities?
  • What are principles and practice of system based inspections?
  • I have heard about different models: FMEA, FTA, ISO 14971, what are these and which one should we use?
  • How to perform a risk analysis?
  • How to to define and start a risk management program?
  • How to define risk categories, e.g., high, medium and low?
  • Does the FDA have a list of high/medium/low risk processes or systems?
  • How to 'justify and document' risk assessment for FDA's 21 CFR Part 11
  • How to save costs through risk based compliance and validation?
  • How does Process Analytical Technology (PAT) help to manage risks?

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 and examples. After the seminar, an extensive list of reference material like SOPs, worksheets, templates and examples will help immediate and cost effective implementation.

During the interactive presentation you learn about:

  • FDA and EU Requirements and Enforcement Practices: GMP, Part 11
  • Risk based system inspections: selection of sites and processes or systems for inspections
  • Guidance from regulatory and industry task forces: ISO, ICH, GHTF, NIST, GAMP/ISPE
  • Models for risk assessment: FMEA, FTA, ISO 14971
  • Developing a strategy and procedures for risk management
  • Starting a risk management program
  • A systematic approach to define high/medium/low risk categories
  • Practical tools for risk assessment
  • Validation steps for high/medium/low risk systems
  • Examples from laboratories, offices and manufacturing
  • Future directions: where is the FDA going?

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

  • PowerPoint Presentation
  • Script
  • Risk Management Master Plan: 40 pages
  • Risk Management in the (Bio)Pharmaceutical and Device Industry
    (Primer, 70 Pagers, May 2011)
  • SOP: Risk assessment Used for GxP Environments
  • SOP: Risk-based Validation of Computer Systems
  • SOP: Risk-based Qualification of Network Infrastructure
  • SOP: Risk-based Validation of Laboratory Systems
  • SOP: Risk Assessment for Laboratory Systems
  • SOP: 21 CFR Part11 - Scope and Controls
  • Reference paper: Risk-based Validation of Off-the-shelf Computer Systems
  • ICH Risk Management guide
  • NIST Guide: Risk Management for IT Systems
  • Risk Management Guide of the Global Harmonization Task Force (GHFT)
  • Warning letters and Inspectional observations related to risk assessment.
  • FDA guidance documents and predicate rules

Who should attend?

  • Regulatory affairs
  • QA managers and personnel
  • Analysts and lab managers
  • Validation specialists
  • Documentation professionals
  • Human resources (HR) managers and staff
  • Training departments
  • Consultants

How to order

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

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 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.