FDA/EU Compliance Workshop

Validation of Analytical Methods for FDA and EU Compliance

April 8, 2011                                              Photos

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 market´s spin off event of Analytica, the world´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.

Agenda

• 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 acceptance criteria
•  Prerequisites for method validation: SOP‘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 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
• 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 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 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

Hands-on Workshop Exercises and Interactive Discussions

The make workshop exercices very effive attendees did get fill-in templates.

1. Define validation parameters and tests for a specific method
2. Define acceptance criteria and limits  for a specific method
3. Define contents of a method validation plan that works in practice
4. Define contents of a validation report acceptable by FDA and EU
5. Define preparation steps for method validation to ensure smooth implementation
6. Define verifications tests for a compendial method
7. Decide to revalidate or not after changes based on USP chapter <621>
8. Define comparative tests for transfer of two specific methods
9. Analyze FDA warning letter, make suggestions for how the warning letter could have been avoided, and for corrective and preventive actions

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:

• Directors
• 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
• Consultants

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 Technology
• Director and chief editor of www.labcompliance.com, the global on-line resource for validation and compliance issues.
• Author of the books “Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Interpharm Press
• Member  of the Scientific Advisory board of IVT’s GxP and Validation Journals,
• 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, click here.

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
	Attendees paying the fee workshop fee.
	Attendees 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 reference material..
	Practical examples, case studies and interactive exercises have been dispersed into and between the presentations.
	All attendees worked to complete the workshop tasks.
	The attendees first worked individually and then discussed the outcome with colleagues.
	Attendees discussing workshop results. Group delegates presented the outcome to all attendees for discussions.
	The interpreter and Ludwig Huber listening to the attendees workshop results.
	The interpreter 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. Contact: Ho Chi Anh, PhD. Senior Environmental Consultant anh.ho@senwork.com 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 their company.
	Ludwig Huber looking for the example validation report on his Laptop.
	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.
	Labcompliance sponsored 5 Laboratory Compliance Packages. The prize was drawn amongst attendees based on participation of discussions.
	I would like to thank Professor Dr. Kettrup for inviting me to present this workshop, Ms. Eva Linner of IMAG for all preparation and organization and all attendees for great discussions.