Validation in Analytical Laboratories for FDA Compliance
Equipment Qualification and System Validation in Laboratories
September 24/25, 2008
Workshop at Analytica China 2008 with Dr. Ludwig Huber
The workshop organized by Munic International Trade Fairs was
held during Analytica China, on 24 and 25 September 2008, at the
Shanghai New International Expo Centre (SNIEC), Shanghai/Pudong.
Analytica China is the Chinese marketÂ´s spin off event of Analytica,
the worldÂ´s largest trade show and networking platform for analysis,
laboratory technology and biotechnology where business is initiated
The workshop was attended by 45 professionals who mainly mainly came from
all parts of China but also from other countries. They came from API
manufacturers, from pharmaceutical and food industry but also from public
Workshop objectives and format
The program was dedicated to quality management and regulatory
science and provided an excellent opportunity to middle and senior
management of pharmaceutical and food companies and government
regulatory agencies to learn about compliance requirements in
laboratories. Practical examples, case studies and interactive
exercises have been dispersed into and between the presentations.
About 50% of the total have been dedicated to practical sessions
with life examples. A large portion of the program has been
dedicated to interactive discussions that also went on long after
the official agenda had been finished.
Agenda Day 1
Validation and Compliance Overview
- FDA and other regulations and inspection practices
- ISO !7025 requirements
- Planning for laboratory compliance
- Sampling: sampling plan, representative sampling,
- Sample handling: preventing deterioration and loss or damage
- Validation of analytical methods: in-house methods,
compendial methods, method transfer
- Developing and validation of stability indicating methods
- Managing failure investigations and OOS results
- Reporting, review and approval of tests results
- Handling chemicals and reference material
- Documentation for ISO and FDA compliance
Agenda Day 2:
Validation of Analytical Instruments and
- Analytical instrument qualification
- Understanding and implementing the new USP standard <1058>
- The equipment qualification life-cycle: 4Q model
- Qualification steps: design, installation, operational and
- System suitability testing: type, frequency and acceptance
- Validation of software and computer systems
- Validation of commercial chromatography systems
- Risk based validation and testing
- Validation of Excel spreadsheets
- Change control procedures: planned and unplanned changes
- Revalidation and review of computer systems
- Definition and handling of raw data and other records
- Acquisition, evaluation and archiving of electronic records
according to CFR Part 11
10+ Reference documents for easy Implementation
Attendees did get free access to a Labcompliance website with lot's of
reference material. The material will help to easily implement what they
have leaned during the workshop.
With master plans checklists, examples, SOPs, and FDA
presentations for easy implementation
The seminar has been attended by 45 professionals
Middle and upper management including:
- QA managers
- Lab managers
- Lab personnel
- Computer system validation managers
- Regulatory affairs
Attendees came from
- International and local pharmaceutical industry
- API manufacturers
- Food industry
- Private and public institutes
- Instrument suppliers
- Service providers
About the speaker: Dr. Ludwig Huber
- Chairman, presenter and panel discussion member at US-FDA
Industry Training sessions and conferences
- Chairman and main speaker of a laboratory compliance
workshop at the Peking University. The workshop was part of a
pharma quality program supported by the US FDA, the Chinese
SFDA, and world leading Pharmaceutical companies.
- Team and/or review member of PDA's task forces "21 CFR Part
11", of US-FDA internal documents, and of the GAMP special
interest group on Laboratory Equipment
- Presenter of the Year of the Institute for Validation and
Director and chief editor of www.labcompliance.com, the global
on-line resource for validation and compliance issues.
- Author of the books â€œValidation and Qualification in
Analytical Laboratories, and "Validation of Computerized
Analytical and Networked Systems", Interpharm Press
- For more information on Ludwig Huber,
The Speaker Dr. Ludwig Huber in Front of the Welcome Board
Selected photos with annotations
||The seminar was
announced outside the seminar room
||Long before the
workshop started attendees arrived and paid the fee
receiving the hand out material.
started with a session on sampling
examples, case studies and interactive exercises have been
dispersed into and between the presentations.
went on and on during the interactive discussion sessions
on case studies
worked to complete the workshop tasks.
introducing the first day's prizes for the lucky draw: Two
video seminars ($449 each) and a one year Labcompliance
||Dr. Ludwig with
the first day's prize winners.
Shelley Wang (left, winner of the video seminar: Laboratory
auditing), Zhang Xiaohang (right, winner of the usersclub
||Also the second
day had lots of practical exercises. They help to better
understand what students have heard in presentations and
||Many attendees did
take the opportunity to take photos with Ludwig. Here the
winner of a Video seminar.
||Ludwig Huber with
Hou Wenyan of
together to complete the exercise tasks.
worked individually on the exercises and then discussed
their results in groups. .
explaining the secrets of most cost effective computer
||Working on the
exercises obviously was a lot of fun.
||Luo Xiao Ping was
the interpreter for both days. He did an excellent job to
ensure smooth communication between the Chinese speaking
audience and English speaking workshop leader.
discussions went on during the exercises
listening to the students reports of the workshop results.
his workshop results and waiting for feedback.
signing the certificates for the luck prize on the second
(middle) with the prize winners of the second day.
Hoover Meng (Usersclub membership),
Shangwei (Laboratory Compliance Package), Xueyun Zhang
(Video seminar: OOS)
Dalian Elite, Jiang Zhao
Labthink (Video seminar: Lab Auditing)
been quite happ with the workshop.
We got many Thank You messages. An example is shown left.
||I would like to
Professor Dr. Kettrup for inviting me to present this
Ms. Eva Linner for all preparation and organization and
Ms. Juliet Crisin
for taking photos.
And all attendees for great discussions.