OECD publishes draft guidance  on the Management, Characterization and Use of Test Items

This guidance provides clarity for test facilities on the expectations of national Good Laboratory Practice (GLP) compliance monitoring authorities on how test items are received, characterized, sampled, handled, stored, archived and destroyed. The document consolidates existing OECD guidance on test items that are used in studies conducted in accordance with the Principles of GLP. It also aims to promote a consistent approach that is appropriate to the objective of the study and the nature of the test item. The guidance is available on the OECD Website

Report from the EMA-FDA QbD Pilot Program

In March 2011, the European Medicines Agency (EMA) and the United States Food and Drug Administration (US FDA) launched a joint pilot program for the parallel assessment of applications containing Quality by Design (QbD) elements. The aim of this program was to facilitate the consistent implementation of QbD concepts introduced through International Council for Harmonisation (ICH) Q8, Q9 and Q10 documents and harmonize regulatory decisions to the greatest extent possible across the two regions. The program was initially launched for three years. Following its first phase, both agencies agreed to extend it for two more years to facilitate further harmonization of pertinent QbD-related topics. The program officially concluded in April 2016. On April 19, 2017, EMA together with FDA published a report on QbD pilot program. Overall, it is concluded that, on the basis of the applications submitted for the pilot, there is solid alignment between both Agencies regarding the implementation of multiple ICH Q8, Q9 and Q10. The report is available on the EMA website.

11 New In-Person Seminars in remaining 2017 with Dr. Ludwig Huber

Labcompliance has extended the offerings for in-Person workshops in several areas: "Data Integrity: FDA/EU Requirements and Implementation", "Validation and Part 11 Compliance of Computer Systems and Data", "GMP Compliance for Quality Control and Contract Laboratories", "Analytical Method Validation, Verification and Transfer", and "Analytical Instrument Qualification and System Validation". All workshops can be delivered as public and as in-house workshops. Currently the workshops are offered in USA, Asia and Europe. For a complete list of workshops with ordering process info and links to pages with individual contents, click here.