Validation in Analytical Laboratories for FDA Compliance

Equipment Qualification and System Validation in Laboratories

September 24/25, 2008                                               Photos

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 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 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 institutes. 

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, documentation
• 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 Computer Systems

• Analytical instrument qualification
• Understanding and implementing the new USP standard <1058>
• The equipment qualification life-cycle: 4Q model
• Qualification steps: design, installation, operational and performance qualification
• System suitability testing: type, frequency and acceptance criteria
• 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:

• Directors
• 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
• Consultants

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 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
• For more information on Ludwig Huber, click here.

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
	Attendees receiving the hand out material.
	The workshop started with a session on sampling
	Practical examples, case studies and interactive exercises have been dispersed into and between the presentations.
	Many discussions went on and on during the interactive discussion sessions
	Attendees working on case studies
	All attendees worked to complete the workshop tasks.
	Dr. Ludwig introducing the first day's prizes for the lucky draw: Two video seminars ($449 each) and a one year Labcompliance Usersclub membership
	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 membership)
	Also the second day had lots of practical exercises. They help to better understand what students have heard in presentations and discussion sessions.
	Many attendees did take the opportunity to take photos with Ludwig. Here the winner of a Video seminar.
	Ludwig Huber with Hou Wenyan of Xian-Janssen Pharmaceutical
	Students working together to complete the exercise tasks.
	Attendees first worked individually on the exercises and then discussed their results in groups. .
	Ludwig Huber explaining the secrets of most cost effective computer validation
	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. Contact info: mobile: 86-15900909640 lxp688791@vip.163.com
	Interesting discussions went on during the exercises
	Dr. Ludwig listening to the students reports of the workshop results.
	Student reporting his workshop results and waiting for feedback.
	Ludwig Huber signing the certificates for the luck prize on the second day.
	Ludwig Huber (middle) with the prize winners of the second day. From left Hoover Meng (Usersclub membership), Shangwei (Laboratory Compliance Package), Xueyun Zhang (Video seminar: OOS) Dalian Elite, Jiang Zhao Labthink (Video seminar: Lab Auditing)
	Attendees have been quite happ  with the workshop. We got many Thank You messages. An example is shown left.
	I would like to thank Professor Dr. Kettrup for inviting me to present this workshop, Ms. Eva Linner for all preparation and organization and Ms. Juliet Crisin (juliet_crisin@qq.com) for taking photos. And all attendees for great discussions.