GMP NEWS 2002

EU-GMP Guide Annex 1 (Sterile Medicinal Products) to Be Revised

5th European API Conference - Review

Poll on 21 CFR Part 11

New WHO Guideline on GMP-compliant Storage - "Good Storage Practices"

Wallhäußer Award for Drug Quality and Safety Given to Dr L. Huber

Systems Inspections 2002 - FDA's New Approach to Inspections

FDA's New Draft Guidance on Electronic Copies of Electronic Records

Revision of the Variations Regulation - New Proposal released on 25 October 2002 - New Categories of EU-Variations

Heidelberg - an Attractive Conference Venue with Optimal Accessibility via Frankfurt

Warning Letter Report - Data Base Publication

First Analysis of the New FDA Draft on Aseptic Processing

Part-11-Compliance CD Finished

Advanced GMP Search Function

The Rapid Alert System for the PIC/S Member Countries

Long-awaited Draft Guide on Aseptic Processing Published

FDA Slides on ICH Q7A Available

Calibration Management Guide Published by GAMP

2 Position Papers on APIs published by APIC

21 CFR 211.198 - Complaint Warning Letters in Detail

Guidances for Part 11 published by FDA on September 5, 2002

Quality, Safety and GMP for Advanced Therapy Medicinal Products (ATMPs)

Recommended Event

Heidelberg, Germany

17/18 June 2020

Quality, Safety and GMP for Advanced Therapy Medicinal Products (ATMPs)

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