The program of the workshop is dedicated to quality management and regulatory science, and provides an excellent oppurtonity to middle and senior management of pharmaceutical companies and government regulatory agencies. The program is supported by the US FDA, the Chinese SFDA, and world leading Pharmaceutical companies. Practical examples, case studies and interactive exercises will be dispersed into and between the presentation. About 50% of the total will be dedicated to practical sessions with life examples.
The workshop takes place during analytica China, on 24 and 25 September 2008, at the Shanghai New International Expo Centre (SNIEC).
Workshop objectives
- Get a thorough understanding of FDA and international drug regulations and guidelines
- Systematically learn how to effectively implement and apply lab-equipment and computer system validation for day/-by-day lab operations
- Understand consequences of non-compliance
- Prepare your lab and organization for successful FDA and international GMP inspections
- Generate, maintain and archive analytical test results with highest accuracy, reliability and data integrity
Contents overview
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
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
Who should attend?
- Directors
- Q&A managers
- Lab managers
- IT managers
- Regulatory affairs
About the speaker
Ludwig Huber, Ph.D., is Director for global FDA compliance at Labcompliance as well as the author and editor of www.labcompliance.com, the on-line resource for validation and FDA compliance and Chief Compliance Advisor at Agilent Technologies. He is also the author of the book "Validation of Computerized Analytical Systems" and "Validation and Qualification in Analytical Laboratories", Interpharm Press, 2002 and 2007. Dr. Huber has been a team and review member of PDAs task force "21 CFR Part11" and "Validation of Laboratory Data Acquisition Systems".
Attendance fee for the two-days seminar
Per person 200 Euro to be paid in advance to Munich Trade Fairs Shanghai (Co.) Ltd.
Contact for your participation
Munich Trade Fairs Shanghai (Co.) Ltd.
Ms. Sky Hong
tel.: +86 (0) 21-50580707 ext 827
e-mail: hong.yan(at)mmi-shanghai.com
Contact for technical details
Dr. Ludwig Huber
e-mail: huber(at)labcompliance.com
