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
Recorded

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.-

|
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:
- Study the printed slide material
- Watch the slides on a computer
- Watch the slides on a video screen in a seminar room
- 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.
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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.