Labcompliance On-line Audio Seminar
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On-line Audio Seminar 379
Understanding the new Revision of USP
With SOPs, Templates and
Examples for easy Implementation
May 11, 2017
USP has released the second in-process revision of Chapter <1058>: Analytical
Instrument Qualification. Changes are based on inputs to the first revision, so
this 2nd rev is much more close to the final chapter than the first revision.
Compared to the current release there are some major changes, for example, the
new revision is proposing for AIQ an integrated approach that is based on risk.
The chapter explains where the risk assessment begins and how the risk
correlates to the complexity of the instruments, There are more new
requirements, e.g., periodic review. The industry has some difficulties to
implement the new requirements, so there are many questions.
Key Questions related to the new
USP <1058> revision
- What are the changes of the new revision to the existing
- When will the new revision be effective?
- Which section of our 1058 SOP do we need to change and how?
- The section on equipment categories disappeared, what to
- When is 1058 mandatory, even so the
chapter number is above 1000?
- How can we apply 1058 to laboratory computer systems?
- The new revision has more details on the four qualification
phases: what exactly should be in each phase:
DQ, IQ, OQ, PQ?
- How to qualify firmware?
- Does the revision answer the
question: What and how much should be tested?
- What to do for integrated systems comprising equipment and
- Does the revision also apply to software frequently used in
laboratories, for example, Excel spreadsheets?
- Who is accountable for the qualification and validation
- How to implement the new revision
- When is the final version coming and what will there be
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 an overview and give practical
recommendations. After the seminar, an extensive list of reference
material like SOPs, test scripts, templates and examples will help
immediate and cost effective implementation. The seminar lasts one
hour and will be conducted over the phone and supported by the
During the interactive presentation you learn
- Terminology, scope and principles of
the new revision .
- Changes to the existing chapter
- AIQ and its relation to method validation, system
suitability testing and quality control checks
- Approaches for risk based qualification: where does risk
- The 4Q Qualification lifecycle approach: DQ, IQ, OQ, PQ
- Purpose and contents of equipment qualification phases:
design qualification, installation qualification, operational
qualification, performance qualification
- Dealing with three
instrument categories A, B and C
- Recommendations for supplier assessment
- Requirements for outsourcing AIQ
- Roles and responsibilities: Quality unit, manufacturer,
- Integrating software validation and equipment qualification
- Integrating the USP 1058 revision with the GAMP Guide on
Laboratory Computerized Systems
- Dealing with changes of software, firmware and equipment
- Qualification of existing/legacy
- Recommendations for effective
implementation of the new revision
- Expectations for the final chapter?
And for easy and instant implementation:
download 10+ documents from special seminar website
- Six examples SOPs
- Analytical Instrument Qualification for <1058>
- Allocating Analytical Instruments to USP <1058> categories
- Procedures and deliverables for USP <1058> categories
- Change control for analytical equipment
- Maintenance of equipment
- Development and maintenance of test scripts for analytical
- Validation plan, URS, DQ
- Risk assessment
- Vendor assessment
- IQ, OQ, PQ
- Validation summary report
- Warning letters and Inspectional
observations related to laboratory equipment qualification.
-:Equipment Qualification in Practice
- Selecting parameters and limits for equipment operational
- FDA Presentation on Equipment
Qualification, includes acceptance criteria
- Slides of the presentation as PPT
files to train others
- Script of the presentation
- All questions and answers from before,
during and after the seminar
Who should attend?
- Laboratory managers and staff
- QA managers and personnel
- Regulatory affairs
- Training departments
- Documentation department
- Validation specialists
May 11, 2017
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.
- Single person
- From the convenience of your desk
- Multiple persons - single site and phone line
- Meet in a seminar or conference room
Recorded seminar -
- Get the CD in your mail
- Useful if you can/could not attend the on-line
seminar. Order includes all reference material.
Recorded seminar -
- Download from the Internet
- Listen and learn whenever you want, wherever you
want. Order includes all reference material.
Special offer for
Labcompliance Usersclub Members
- Order includes all reference material.
- for Usersclub information and registration,
from US$ 149.-
Please forward to your colleagues, just
About audio seminars
Online audio seminars are
presented over the phone. During the live presentation attendees
- Study the printed slide material
- Watch the slides on a computer
- Watch the slides on a video screen in a
- 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
||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,
. Ludwig Huber in Panel Discussions with FDA Officials
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.
(right) and John Murray, FDA's Computer Validation Expert,
(left), speaking at the IVT Computer System Validation
Mr. Murray explained FDA's next steps for Part 11
(right) in a panel discussion with FDA inspectors and
Dr. Robert C. Horan, B Erik Henrikson,Joseph Famulare, and