Labcompliance On-line Audio Seminar
Learn from the convenience of your desk or
with your colleagues in a seminar room
(to learn more about audio seminars,
click here)..
On-line Audio Seminar 238
Documentation for FDA
and EMEA Compliance
Strategies and tools for
development, approval, distribution and updates
March 25, 2010
Documentation is most important in the regulated world. "If
it is not documented, it is a rumor" is a famous saying when dealing with FDA
and other agencies. "Documentation not available", or "Documentation not
adequate" are most frequently cited deviations in FDA Warning Letters. With a
good understanding of the regulations, good common sense, good science or good
engineering it is easily possible to be in compliance with technical
requirements, however to comply with documentation is not so easy. It is not
enough, to have everything documented, it is equally important to have the right
documents with the right format. This is where the industry struggles with..
Key Questions related to FDA/EMEA compliant documentation
- Where can I find which documents we need
for FDA?
- Which documents are required for EU
inspections?
- Does the FDA or EU require specific
contents or formats?
- Who is responsible for documentation?
- What is the right format for each
document?
- Who should review, approve and sign
documents?
- Do we always need SOPs or can we use our
installation and test scripts?
- For how long should we keep the
documents?
- What is the best media for document
archiving: electronic, paper or microfiche?
- I want to archive all my documents
electronically, can I scan my paper and destroy the paper
- How useful are document management
systems and should they comply with 21 CFR Part 11?
- How to sign documents electronically?
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. After
the seminar, an extensive list of reference material like SOPs,
templates and examples will help immediate and cost effective
implementation.
During the interactive presentation you learn
about:
- Documents required by the US-FDA
- Documents required by international
agencies
- Developing an SOP for generation and
maintenance of documentation
- Handling electronic documents
- Managing documents: Electronic vs. paper
- Archiving paper documents electronically
- Preparing documentation for national and
international inspections
- Compliance of electronic document
management systems
- Practical tips for writing documents
- Going through examples
- master plans
- SOPs
- test protocols
- validation documents
- batch records
- training records
- Sharing best practices
- Frequently made mistakes
- Frequently asked questions and answers
And for easy and instant implementation:
download 10+ documents from special seminar website
- PowerPoint Presentation
- Script
- All questions and answers from before,
during and after the seminar
- SOPs:
- Document Management and Control for GxP Compliance
- Development and Maintenance of SOPs
- Scanning of Paper Records for GxP Compliant Archiving
- Retention and Archiving of Electronic Records
- Handling Deviations from SOPs
- Examples
- Test traceability matrix
- Test scripts
- Requirement specifications: good and bad exampes
- Validation documents
- Training records
- Regulatory reference documents:
- FDA Drug cGMP: Requirements for Laboratory Records
- FDA Drug cGMP: Requirements for Manufacturing Records
- FDA CGP: Requirements for Clinical Trials Records
- Five Warning letters and/or Inspectional
observations related to documentation
- FDA guidance documents and predicate
rules
- And more
Who should attend?
- Food, environmental, chemical and
pharmaceutical testing laboratories
- Laboratory managers and staff
- Documentation department manager and
staff
- QA managers and personnel
- Analysts and lab managers
- Validation specialists
- Regulatory affairs
- Human resources (HR) managers and staff
- Training departments
- Documentation department
- Consultants
Date, time and duration
March 25, 2010
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
How to order
Pick one of the options in the table that fits your needs.
|
Standard offer
- Single person
- From the convenience of your desk
|
US$ 249.-
|
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'Site' offer
- Multiple persons - single site and phone line
- Meet in a seminar or conference room
|
US$ 399.-
|
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Recorded seminar -
CD
- Get the CD in your mail
- Useful if you can/could not attend the on-line
seminar. Order includes all reference material.
|
US$ 399.-
|
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Recorded seminar -
Download Version
- Download from the Internet
- Listen and learn whenever you want, wherever you
want. Order includes all reference material.
|
US$ 399.-
|
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Special offer for
Labcompliance Usersclub Members
- Order includes all reference material.
- for Usersclub information and registration,
click here
|
from US$ 149.-
|
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 author of the Labcompliance
Newsletter. He has been conducting over 100 web and audio or video based
seminars since ten years. He is worldwide director for FDA compliance at Agilent
Technologies.
|
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 visits FDA in Rockville, VA, and
participates in panel discussions with FDA professionals. For more
information,
click here.