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..

See recent similar workshop in Mumbai with Dr. Ludwig Huber

The presenter Dr. Huber just completed a compliance workshop in Mumbai. To get an impression of the interactive style of Dr. Huber's seminars and workshops click here, especially look at the photos.

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