FDA/EU Compliance Workshop
Validation of Analytical Methods for FDA and EU Compliance
April 8, 2011
Workshop at Analytica Vietnam 2011 with Dr. Ludwig Huber
The workshop organized by Munich International Trade Fairs was
held during Analytica Vietnam, on April 8, 2011, at the Hoh Chi Minh
City New Saigon Exhibition & Convention Centre (SECC), Hoh Chi Minh
City. Analytica Vietnam is the Vietnamese 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 and advanced.
The workshop was attended by 35 professionals who came from all parts of
Vietnam. They came from API manufacturers and pharmaceutical companies, from
contract laboratories and food industry but also from public institutes and
universities. They represented QA, QC and also Laboratory management.
Workshop objectives and format
The program was dedicated to quality assurance laboratories and
regulatory science and provided an excellent opportunity to middle
and senior management of pharmaceutical, API and food companies and
government regulatory agencies to learn about requirements for
analytical methods validation 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 interactive discussions and practical sessions with
life examples. Discussions went on discussions that also went
on long after the official agenda had been finished.
- FDA/EU, ICH, USP and ISO 17025 requirements, regulatory
expectations and inspection practices
- Understand the inspectors' questions
- Developing a validation plan and protocol in line with
regulatory and quality standard requirements
- Form a validation and team and understand key expectations
of each member.
- Define the scope of methods, validation parameters and
- Prerequisites for method validation: SOPâ€˜s, qualified
instruments, qualified materials, trained analysts
- Design experiments for 9 validation parameters
- Define acceptable number of variables experiments when
determining intermediate precision and reproducibility
- Define the minimum number of experiments to satisfy ICH, FDA
- Statistical evaluation of validation results for:
repeatability, intermediate precision, reproducibility,
linearity, range, limit of detection, limit of quantitation,
robustness and specificity
- Going through the difference between verification and
- Transfer of analytical methods according to USP <1224>
- Verification of standard and compendial methods according to
- Recommendations what, when and how to revalidate after
changes according to USP and EP
- Criteria for method adjustments vs. changes and the impact
on revalidation and documentation
- Going through seven real world method modifications with and
without the need for revalidation
- Development and validation of stability indicating methods
using stress testing
- Preparing validation reports in line with regulations and
- Going through a validation report - from beginning to end
- Going through the complete validation package for FDA
submissions and inspections.
- Seven most common method validation pitfalls and how to
Hands-on Workshop Exercises and Interactive Discussions
The make workshop exercices very effive attendees did get fill-in
- Define validation parameters and tests for a specific method
- Define acceptance criteria and limits for a specific method
- Define contents of a method validation plan that works in practice
- Define contents of a validation report acceptable by FDA and EU
- Define preparation steps for method validation to ensure smooth
- Define verifications tests for a compendial method
- Decide to revalidate or not after changes based on USP chapter <621>
- Define comparative tests for transfer of two specific methods
- Analyze FDA warning letter, make suggestions for how the warning
letter could have been avoided, and for corrective and preventive
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 35 professionals
Middle and upper management including:
- QA managers
- QC 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
- Contract laboratories
About the speaker: Dr. Ludwig Huber
- Chairman, presenter and panel discussion member at US-FDA
Industry Training sessions and conferences
- 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
- Member of the Scientific Advisory board of IVTâ€™s GxP and
- Dr Huber has given multiple presentations mainly on GLP/GMP,
21 CFR Part 11 and Validation around the world. This included
seminars and presentations for the US FDA, PIC/S, PDA, GAMP,
ISPE, USP and several national health agencies in Singapore,
Korea, US-FDA, Thailand and China.
- For more information on Ludwig Huber,
The Speaker Dr. Ludwig Huber in Front of the Welcome Board
Selected photos with annotations
||Attendees had to
leave their home early to get through the heavy Hoh Chi Minh
City morning traffic. Many came with motorcycles
||Long before the
workshop started attendees arrived at the New Saigon
Exhibition & Convention Centre
the fee workshop fee.
receiving the handouts
||All seats were
occupied when the workshop started at exactly 9.00 a.m.
||Dr Ludwig Huber
explained the agenda, the interactive format and the
examples, case studies and interactive exercises have been
dispersed into and between the presentations.
worked to complete the workshop tasks.
first worked individually and then discussed the outcome
discussing workshop results. Group delegates presented the
outcome to all attendees for discussions.
and Ludwig Huber listening to the attendees workshop
Dr. Ho Chi Anh, not only did a great job to translate the
talks into Vietnamese. He also had translated all slides
into Vietnamese as a special service.
Ho Chi Anh, PhD.
Senior Environmental Consultant
Tel: (84) 937742668
||The slides have
been translated into Vietnamese and can be downloaded from
the reference website,
They can be used by attendees to train their colleagues in
Ludwig Huber looking for the example validation report on
||Examples like this
validation report will help attendees to quickly implement
what they have learned in the workshop.
||Many attendees did
take the opportunity to take photos with Ludwig Huber.
Compliance Packages. The prize was drawn amongst
attendees based on participation of discussions.
||I would like to
Professor Dr. Kettrup for inviting me to present this
Ms. Eva Linner of IMAG for all preparation and organization
all attendees for great discussions.