Labcompliance Video Seminar 102
Video clips are recorded and imbedded in PowerPoint presentation
slides. This allows highest flexibility. For example slides and
clips can be skipped or replayed several times. The PowerPoint
presentation with video clips come on a CD or as web download.
Reference material such as 10+ best practice documents can be
downloaded from a password protected website. The site and its
updates can be accessed for two years.
Video Seminar 102
How to Prepare Your Organization for the
'New' Part 11
Learn What's Coming and How to Implement
With Dr. Ludwig Huber
In 1997 the United States Food and Drug Administration (FDA) issued a regulation
that provides criteria for acceptance by the FDA of electronic records,
electronic signatures and handwritten signatures. This was done in response to
requests from the industry. With this regulation, entitled Rule 21 CFR Part 11,
electronic records can be equivalent to paper records and handwritten
signatures. However, this first release was almost impossible to implement.
Therefore the FDA changed the approach as documented in a Guidance from 2003.
However, the industry is unsure what to do, Nevertheless since 2006 FDA did go
out and enforced Part 11 related issues and more inspections are coming in 2010.
- What are the key requirements of Part 11?
- Which ones are really enforced?
- We already have a Part 11 program: what should we change
- How can we be sure that we do it right this time?
- What is FDA's new scope and current thinking?
- Which systems should comply with Part 11
- When is electronic audit trail a 'must'?
- How to deal with legacy systems?
- How to develop and implement a gap analysis and remediation
- What is FDA's current thinking and enforcement strategy?
- How to document risk assessment for Part 11
- Where to get reference material (gap analysis, examples,
worksheets, SOPs) for easy implementation?
How does the video seminar help:
Based on presentations, publications and private communications
with FDA professionals it is quite easy to predict what the changes
will be. Answers to the question will be presented by the Part 11
world expert Dr. Ludwig Huber in a new interactive video seminar.
During the seminar, the speaker will present strategies and give
practical recommendations. After the seminar, an extensive list of
reference material like SOPs, gap analysis, implementation plan
templates and examples will help immediate and cost effective
During the interactive presentation you learn:
- Overview on the spirit of Part 11 and requirements
- FDA's current inspection and enforcement practices: a risk
- Recommendations from industry task forces, e.g., GAMP®
- FDA's new interpretation: learning from FDA guidance, and
recent FDA conference presentations and discussions
- Learning from recent warning letters
- Recommended changes to existing Part 11 programs to reduce
- Cost effective Part 11 strategies according to current FDA
- A six step plan for implementation
- Justification and documentation for the FDA and your
- Case studies from laboratories, offices and manufacturing
Get 10+ Documents To Do it Right The First Time:
download from special seminar website
Part 11 Compliance Master Plan
- Ideal to develop or update your company's Part 11 program
- Define and Document Scope and Controls for Part 11
- Risk Assessment for Systems Used in GxP Environments
- Training for GxP and Part 11
- Retention and Archiving of Electronic Records
- 21 CFR Part 11
- 15 Part 11 Case Studies
- Requirement Specifications for Part 11
Most frequently asked questions and answers
FDA Presentation about Part11
George Smith, FDA: Part 11 - Where we were, Where we are, Where
Warning letters and Inspectional observations
related to 21 CFR Part11FDA/EU Guidance documents related to
electronic records/signatures and computer validation
Who should attend?
- Part 11 groups
- System owners
- Software developers
- IT managers and system administrators
- QA managers and personnel
- Analysts and lab managers
- Validation professionals
- Training departments
- Documentation department
Cost and Ordering
Video seminar - Web download
- Download the video presentation from a password protected website
(approx. 150 Mbytes)
- Order includes all reference material.
- Share the video and all reference material at your site
Video seminar - CD
- Get the CD in your mail
- Order includes all reference material.
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
||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,