Labcompliance On-line Audio Seminar
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available on CD and for instant download. All reference material as
listed below and more is available on a special seminar website. The
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On-line Audio Seminar 301
Using Electronic and Digital Signatures in Regulated Environments
Comply with FDA Part 11 and with
international regulations and guidelines
Recorded, available with all reference material
at any time

FDA Part 11 and other regulations such EU GMP Annex 11 allow to sign electronic
records with electronic and digital signatures. Benefits for regulated user
firms are increased overall efficiency and reduced costs for handling and
storing paper records. While nearly all Part 11 related papers and seminars deal
with requirements of electronic records there is hardly any information
about electronic and digital signatures. Therefore most companies are unsure
about electronic signatures such that they print out copies of electronic
records and sign the paper.
Key questions about electronic and digital signatures
are:
- What are electronic signatures
- What is the difference to digital signatures
- What are the Part 11 requirements
for e-signatures?
- What are differences to other
regulations, EU Annex 11
- Which documents need to be signed
- Are there any specific issues during FDA and other
inspections
- How to link signatures with
records?
- Are PDF signatures Part 11 compliant?
- Can we use digital pens to create electronic signatures
- How to 'certify' electronic signatures for FDA
- How to avoid unapproved editing of e-signed documents?
- How to use electronic signatures in Excel?
How does the on-line 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. After
the seminar, an extensive list of reference material like SOPs, gap
analysis, implementation plan templates and examples will help
immediate and cost effective implementation.
During the interactive presentation you
learn:
- Definitions of electronic vs. digital signatures
- Benefits of electronic signatures
- Examples of using e-signatures day-by-day
- Part 11 requirements for electronic signatures?
- European and international requirements
- Applications and requirements of digital signatures
- Inspection and enforcement practices
- Specific software requirements for electronic signatures
- How to document the meaning of the signature
- Using digital pens for electronic signatures
- Validation of electronic signature software
- Certification of electronic signatures for the FDA
- FDA compliant training of accountability for e-signatures
- Using electronic signatures in Excel
Get 10+ Documents To Do it Right The First
Time:
download from special seminar website
- Part 11 Compliance Master Plan
- with section on electronic signatures
- SOPs:
- Using Electronic Signatures in FDA Regulated Environments
- Access control to computer systems and data
- Gap analysis/checklist:
- 21 CFR Part 11
- Using Electronic Signatures in Regulated Environments
- Templates/examples
- Requirement Specifications for Electronic Signatures
- Example: Letter to the FDA about using Electronic Signature
Certification
- Example: Statement on Accountability for Electronic
Signatures
- Tutorial: Getting and using Digital Signatures for E-mails
- Warning letters and Inspectional
observations related to Part 11 and signatures
- FDA Regulation 21 CFR Part 11: Electronic Records and
Signatures
- EU GMP Annex 11: Using Computerized Systems
- FDA Guidelines Related to 21 CFR Part 11
- Unites States: Electronic Signatures in Global and National
Commerce Act
(E-sign act)
- NIST Guidance on Implementing the electronic signatures in
global
and national commerce act (e-sign)
- National Archive and Records Administration: Records
Management Guidance for PKI Digital Signature Authentication and
Secure Transaction Records
- Directive 1999/93/EC of the European Parliament on a
Community framework for electronic signatures (EU Digital
signature directive)
- PowerPoint Presentation
- Script
- All questions and answers from before,
during and after the seminar
Who should attend?
- Everybody using computers in FDA
regulated environment?
- Part 11 groups in Bio(pharmaceutical) and
device industry
- System owners
- Software developers
- IT managers and system administrators
- QA managers and personnel
- Analysts and lab managers
- Validation professionals
- Training departments
- Documentation department
- Consultants
Date, time and duration
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.-

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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.
. Ludwig Huber in Panel Discussions with FDA Officials
 |
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 explained FDA's next 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, |