FDA Compliance in Analytical Laboratories 12-14 November 2008 Berlin, Germany Please click here to view the program of this conference or course To book for this program, just click on the option: Book this option: Non-ECA Members (EUR 1990,--) Book this option: ECA Members (EUR 1791,--) Book this option: EU GMP Inspectorates (EUR 995,--) Book this option: APIC Members (does not include ECA membership) (EUR 1890,--)
At this conference we offer a Conference Exhibition. Please click here in order to view the registration form (PDF) for exhibitors.
LEARNING OBJECTIVES: FDA Inspections cGMP Compliant Documentation in QC Laboratories Analytical Instruments - Qualification according to USP <1058> - Calibration - Computer Validation Practical Ways to Validate Excel Spreadsheets Reference Standards: a Risk-Based Life Cycle Approach Analytical Methods - Validation - Method Transfer Out-of-Specification Results - The final FDA OOS Guidance Training Case Study Stability Testing Objectives The purpose of this three-day education course is to give participants a comprehensive overview of FDA’s current compliance requirements (21 CFR Part 211, Guidances for Industry, Compliance Program Manual, etc.) and expectation in these and related areas, and how they can be managed effectively. The format allows each of our speakers to give an overview of the specific regulatory requirements associated with their topic prior to describing the approach to managing the issues with respect to philosophy, documented procedures, SOPs, etc. In addition, the programme includes four workshop sessions covering: - Method Validation - Out of Specification Results - Validation of Excel Spreadsheets - Method Transfer The course will also discuss the implication of new developments resulting from recent FDA initiatives. Background A major consequence of the Barr Ruling in 1993 was the significantly greater emphasis FDA inspections placed on the management and performance of quality control laboratories, and particularly the handling of Out of Specification results. As a result of the increased and on-going scrutiny of analytical performance it is hardly surprising that even today the most frequently cited cGMP non-compliances are still found in laboratories, particularly: General cGMP understanding and particularly relating to SOP compliance Validation, performance and transfer of analytical procedures Equipment qualification and calibration Computer validation (including the requirements and actual interpretation of 21 CFR Part 11) Operator training