Full-Day Workshop at the Anacon/Analytica
Conference, India
Validation
of Analytical Methods for FDA and EU Compliance
Dr. Ludwig Huber,
October 13, 2011,
Mumbai, India
The workshop is dedicated to senior analysts and
laboratory and QA Management of pharmaceutical development and routine
laboratories and for API manufacturers. The workshop will give attendees the
background to understand the requirements and even more importantly it will
focus on strategies and provide tools to implement most critical method
validation requirements. Practical examples and interactive exercises will be
dispersed into and between the presentations. About 50% of the total will be
dedicated to practical sessions with life examples..
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What attendees will learn
- Laboratory management, supervisors and senior analysts
- QA managers and personnel
- FDA/EU, ICH, USP and ISO 17025 requirements,
regulatory expectations and inspection practices
-
Understanding what questions will be asked
during audits and inspection
- How to develop a validation plan and protocol in line with
regulatory and quality standard requirements
- How to form a validation and team and understand key
expectations of each member.
- Defining the scope of methods, validation parameters and
acceptance criteria
- Prerequisites for method validation: SOP‘s, qualified
instruments, qualified materials, trained analysts
- Designing experiments for nine validation parameters
- Defining the minimum acceptable number of variables and
experiments when determining intermediate precision and
reproducibility
- Defining the minimum number of validation experiments that
satisfy ICH, FDA and USP
- 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
validation
- How to transfer of analytical methods according to USP
<1224>
- Verification of standard and compendial methods according to
USP <1226>
- Recommendations what, when and how to revalidate after
changes according to United States and European Pharmacopeia
- 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
quality standards
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
avoid them
- Special considerations for methods used for biological fluid
analysis
Who should attend
- Laboratory management, supervisors and senior analysts
- QA managers and personnel
- Regulatory affairs
- Consultants
from
- Pharmaceutical development
- Pharmaceutical manufacturers
- API manufacturers
- CROS doing clinical studies
- Contract laboratories
- Regulatory agencies
- Laboratory suppliers of material, equipment and services
Agenda
09:30 - 10.00 |
Registration
|
10:00 - 10:15 |
Welcome and Introduction
|
10.15 - 10:30 |
FDA/EU, USP and ICH requirements and inspection
reports
- US FDA requirements and guidelines
- Inspection practices - Examples of FDA Warning
Letters
- Understanding the Inspector's questions
- USP, ICH and EU Requirements
- Terminology: Validation, qualification and
verification
|
10:30 – 11:30 |
Validation and test parameters
- Validation parameters according to ICH Q2 and USP
- Going through 9 ICH test parameters
- Selecting test conditions and acceptance criteria
for different sample types
- Workshop Exercise and Q&As
|
11:30 - 12-00 |
Coffee Break
|
12:00 – 13:00 |
Iterative method development and validation
- Preparation phase
- Validation activities during development
- The importance of robustness testing
- Executing the tests
- Workshop Exercise and Q&As
|
13:00 – 13.30 |
Documentation of test results
- ICH and FDA requirements for documentation
- Going through through a complete validation package
- Validation requirements along drug development
phases
- Post-validation activities
- Workshop Exercise and Q&As
|
13:30 – 14:30 |
Lunch Break
|
14.30 – 15:00 |
Transfer of Analytical Methods and Procedures
- USP <1224> with 4 options for method transfer
- Focusing on comparative testing
- Examples for testing: FDA guidance as case study
- Handling deviations
- Workshop Exercise and Q&As
|
15:00- 15:30 |
Validation of Compendial Methods
- FDA and international requirements
- USP <1226> for method verification
- Risk assessment as criteria for type and extend of
testing
- Examples for verification testing
- Workshop Exercise and Q&As
|
15:30 - 16:00 |
Method Changes and revalidation
- Method changes vs. adjustments
- Changes that require revalidation
- Practical recommendations from USP <621> and EP 5
- Initiating, approving and formally releasing changes
- Workshop Exercise and Q&As
|
16.00 – 16:30 |
Tea Break
|
16:30 – 17:00 |
Validation of Stability Indicating Methods
- FDA and International requirements
- Forced degradation to generate suitable samples
- Strategies and examples for validation and testing
- Test procedures and documentation
- Workshop Exercise and Q&As
|
17:00 - 17:30 |
Special Considerations for methods used for body
fluids
- FDA and International requirements
- Difference to methods used for APIs and drugs
- Test conditions and acceptance criteria
- Quality assurance during routine analysis
|
17:30 - 18:00 |
Final Questions and Answers - Wrap up - Prize
Draw
- Most common method validation pitfalls and how to
avoid them
- Going through most frequently asked questions
- Final questions and answers and wrap-up
- At the end there will a lucky draw for valuable
prizes, for example for the Labcompliance Package ($599)
and Labcompliance Users Club ($379)
|
Course registration fee
- 2500 Rubin, including copies of all slides
Reference Material for Easy Implementation
- 70-page e booklet written by Dr. Ludwig Huber about
"Validation of Analytical Procedures"
- SOP: Validation of Analytical Methods
- SOP: Transfer of Analytical Procedures
- SOP: Verification of Compendial Methods
- Checklist: Validation of Analytical Methods
- Example: Validation Summary Report
Course Location and Registration
Course Location: Bombay Exhibition Center, Mumbai
For registration click on
http://www.analyticaindia.com/en/Home/conference-program/Workshop
Or download the registration form and submit it to the Fax Number as
shown on the form.
http://www.labcompliance.com/seminars/external/anacon2011/regis.pdf
About the course director
Ludwig Huber,
Ph.D., is Director for global FDA compliance at Labcompliance. He is
the author and editor of
www.labcompliance.com, the on-line resource for validation and
laboratory compliance.
-
He studied
chemistry and received his PhD. from the University of
Karlsruhe, Germany. He is also the author of the
bestselling books “Validation of Computerized Analytical
Systems” and “Validation and Qualification in Analytical
Laboratories,”.
-
He
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, ISPE, PDA, PIC/S and several
national health agencies. For more information, please check the
website:
http://www.ludwig-huber.com
|
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 an IVT conference conference 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.
Dr. 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 explined FDA'snext 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, |
First International GLP Award from Indian Drug Manufacturer
Association
Dr. Ludwig Huber, Chief Advisor and Editor of Labcompliance,
received the First International GLP award for his research
and publications on GLP and GMP from the Indian Drug
Manufacturer Association (IMDA). The winner has been a
selected by a committee of members from the Advisory Board
of IMDA
 |
Dr. Ludwig Huber
from Agilent Technologies received IDMA's First
International GLP Award from the president Mr. Isran |
 |
Ludwig Huber
presenting the key note address |
 |
All IDMA award
winners together with the organization committee. Main
attraction was Ludwig Huber with flowers in the middle. |
 |
Ludwig Huber
donating his two validation reference books to Mr.
Sipahilanami for the IDMA |
 |
Ludwig Huber has
been interviewed by two journalists.
They asked him about his view on positioning of Indian
Pharmaceutical industry in global market place. |
 |
Ludwig Huber
celebrating this success in a fine restaurant with his
favorite colleges and friends from Agilent India, Sanjev
Dhar and Ganapathy Ramakrishnan (Rama, right), country
manager of Agilent India |