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
To share this seminar info with your colleagues,
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Testimonials
We have received very positive feedback from
attendees of this and previous seminars related to Part 11. To
learn how the seminar helped to understand and implement Part 11
and to prepare companies for Part 11 inspections,
click here.
On-line Audio Seminar 270
How to Prepare Yourself
for FDA's on-going Part 11 Inspection
Program
Learn what the FDA is
looking for and how to respond
Recorded, available with the reference material
at any time

Within the next few weeks and months the FDA will
continue to conduct a series of Part 11 related inspections.
Planned routine inspections will be extended to evaluate the companies'
practices to ensure integrity, authenticity and availability of electronic
records, and the FDA plans additional 'for cause inspections'. Inspections are
on-going and are further planned for US but also in foreign
countries. The program is the long awaited next step for Part 11 and
nevertheless it came as a surprise to the industry. There are many questions
about the program and further steps::
Key Questions related to FDA's Part 11 Inspection Program
are:
- Are there any conclusions from recent FDA Part 11
inspections?
- Are 3rd party service providers part of
the program, e.g., CROs?
- Will there be a list of companies that
have been or will be inspected?
- Will the outcome of inspections be made
available to the public, e.g., through warning letters?
- For how long will the program
last?
- How many inspections will be part of the
program?
- Could preclinical (GLP) studies be part
of the program?
- Is there be a dedicated Part 11
inspection team?
- Is the material used to train inspectors
available to the the public, and if so how can we get it?
- Are inspectors trained on what to look at
specifically?
- It seems, that record integrity is a key
issue, Is there a standard how records are protected ?
- Do inspections take longer because of
Part 11?
- Will there be a process to review the
inspection reports to ensure consistency?
- Are there certain things inspectors
do always look at?
- Is there a standard inspection
questionnaire?
- What are the recommendations for clinical
record systems?
- How doe the
program impact inspections of Medical Device manufacturers?
- Validation is one important requirement,
is there a guidance from the FDA?
- How should we prepare our department for
inspections?
- How can we fix most critical Part 11
issues short term?
- Is enforcement discretion still applied
and if yes for which requirements?
- What are the most likely Part 11 steps
after this program?
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 give very detailed information on the FDA program and answer
all questions above and more. He also will provide information on
FDA's expectation how Part 11 requirements should be implemented..
After the seminar, an extensive list of reference material like case
studies, SOPs, checklists and templates will help immediate
and cost effective implementation of a Part 11 program that is in
line with current and future FDA's expectations. The seminar lasts
one hour and will be conducted over the phone and supported by the
Internet.
During the interactive presentation you learn
about:
- FDA inspections: Preparation, conducts,
follow up
- Scope of the on-going
Part 11 program: time frame, expected outcome
- Learning from previous inspections with
focus on Part 11 and computer validation: most frequently cited
deviations
- Conclusions from the ongoing program
- Criteria for selection of target
companies
- What inspectors are looking at
- How to prepare your company for the
upcoming inspections
- How to fill gaps short term
- Developing a program for long term
- Creating the right documentation to satisfy the inspectors
- Most likely next steps after the inspection program
And for easy and instant implementation:
download 10+ documents from special seminar website
- PowerPoint Presentation
- Script
- Part 11 Compliance Master Plan
- Part 11: Step-by-step Implementation
- Four example SOPs:
- 21 CFR Part 11: Scope and Controls
- FDA Inspections: Preparation, conduct, follow up
- Electronic Audit Trail: Specifications, Implementation,
Validation
- Retention and Archiving of Electronic Records
- Examples
- Requirement Specifications: Electronic Audit Trail
- Part 11 Requirement Specifications
- Checklists
- Part 11 Compliance
- Using Computers in FDA Regulated Environments
- Case Studies
- Implementing Part 11 (15 examples for pharma, devices and
clinical studies)
- How to avoid Part 11 related 483's and Warning Letters
- How to respond to Part 11 related 483's and Warning Letters
- Warning Letters and Inspectional
Observations with typical deviations related to computer
validation and Part 11 compliance
- Publications
-:Risk based validation of software and computer systems
- FDA Presentations:
- George Smith: Update on Part 11 Inspection Assignments
(June 2011)
- George Smith: CDER Part 11 Inspection Assignments (July 2010)
- Edwin Rivera: Data Integrity and Fraud - Another Looming
Crisis?
- Steve Wilson: FDA Regulatory Perspective on Data Integrity
Who should attend?
- Everybody using computers in FDA
regulated environments
- IT manager and staff
- QA managers and personnel
- Regulatory affairs
- Training departments
- Consultants
- Validation specialists
Date, time and duration
July 14, 2011
North America: ET 11 a.m. CT 10 a.m. PT 8 a.m., Europe: CET
5 p.m (Paris/Berlin)
Check: www.timeanddate.com/worldclock/ for you local time.
The seminar will last one hour
Date and time
Recorded seminar, available at any time with all reference
material
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.-

|
Please forward to your colleagues, just
click here
 |
George Smith,
FDA's national Part11 expert, at a panel discussion with
Ludwig Huber during an IVT conference
Smith and Huber discussed and answered questions about
computer system validation and e-records. |
 |
Ludwig Huber
(right) and John Murray, FDA's Computer Validation Expert,
(left), speaking at the IVT Computer System Validation
Conference.
Mr. Murray explined FDA'snext steps for Part 11
|
 |
Ludwig Huber
(right) in a panel discussion with FDA inspectors and
directors:
Dr. Robert C. Horan, B Erik Henrikson,Joseph Famulare, and
Nicholas Buhay, |
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.
|
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.
Testimonials/References
The Feedbacks on the seminar has been
received by e-mails. Labcompliance has permission to use the
testimonials as references. Original e-mails are stored in the
Labcompliance archive.
- Seminar: Understanding and Preparing for
FDA's New Part 11 Inspection Program
Feedback:
The seminar did exceed my expectations. The
seminar is very useful as it contains a lot of information.
Mr. Lucian Hirtie, QS Manager, Labstat International ULC, Canada
(Ref T-1082).
- Seminar: Understanding and Preparing for
FDA's New Part 11 Inspection Program
Feedback:
The seminar did exceed my expectations. Very
informative presentation, and clearly presented . Dr Huber does an
excellent presentation, well developed, and very informative, as usual.
Mr. John Egoville, Senior Compliance Auditor, Computer Validation
Group, TEVA Pharmaceuticals, USA (Ref T-1081)
- Seminar:
Recent Warning Letters and 483's Related to Computer Validation and Part
11
Feedback:
The seminar did exceed my expectations. The
presentation contains much more pertinent information than I had
expected.
Mr. Joachim Fehr, Stryker, CSV Specialist QA, Germany (Ref
T-1076).
- Seminar:
FDA's New Enforcement of 21 CFR Part 11
Feedback:
The seminar did meet my expectations. I always
expect a wonderful seminar from Dr. Huber, and my expectations were once
again met. A great time saver for me as I do not have time to look up
recent 483s relating to Part 11 -- worth the time and cost.
Ms. Diana Mayes, Manager of ABC Laboratories, USA (Ref T-1077).
- Seminar:
FDA's New Enforcement of 21 CFR Part 11
Feedback:
The seminar exceed my expectations. Webinar was
very informative to our current practice and will help us focus and
stream line our process. I would recommend this seminar to everyone
having the same responsibilities.
Ms. Mike Robertson, QA Engineer at Energizer, USA (Ref T-1078).