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GMP News Overview 2003

37112.12.2003FDA Develops Quality Systems Guidance
(Labcompliance News from Dr Ludwig Huber)
37011.12.2003Adjustment versus Modification - Interpretation of the Ph.Eur. Requirements
36910.12.2003ICH Q8 and ICH Q9 Coming Soon!
42801.12.20036th APIC 2003
36514.11.2003EMEA Plans Revision of the Note for Guidance on Plastic Primary Packaging Materials
36413.11.2003Current Inspection Findings of the British Supervisory Authority MHRA (Formerly MCA)
35520.10.2003FDA Requirements on the Qualification of Component Suppliers
35313.10.2003New PIC/S Guidance on Computer Validation
35122.09.2003Analysis of Our Internet Survey of 28 August 2003
34818.09.2003First Consequences for Process Validation and Equipment Qualification According to the New FDA Draft Guidance on Aseptic Processing
34708.09.2003FDA Draft Guidance for Industry:áSterile Drug Products Produced by Aseptic Processing
34608.09.2003Final Version: Guidance for Industry, Part 11, Electronic Records; Electronic Signatures - Scope and Application
34508.09.2003NEW:áPAT (Process Analytical Technology) Draft Guidance from FDA!
33928.08.2003Is it possible to fulfil the new requirements of the revised Annex 1 to the EC Guide on the Manufacture of Sterile Medicinal Products?
34027.08.2003FDA's Expectations on the Training Documentation of Laboratory Staff
34126.08.2003Insight into the New ISPE Guide: "Assessing the Particulate Containment Performance of Pharmaceutical Equipment"
33506.08.2003Will the GMP Regulations Be Harmonised Worldwide?
33022.07.2003Heidelberg - an Attractive Conference Venue with Optimal Accessibility via Frankfurt
32921.07.2003FDA's System-based Approach to Inspections as Reflected in the Warning Letters
32818.07.2003Commission Directive 2003/63/EC: The New Annex 1 to Directive 2001/83/ EC
32118.06.2003FDA Presents Its Analysis of Observations Noted on 483 Forms
31817.06.2003Batch Release and Certification in the European Context -
The MRA between Europe and Switzerland
31616.06.2003CPMP Guideline on NIR Adopted
31520.05.2003New Release: GMP Navigator on CD-ROM 5.0
31102.05.2003VDI Guideline 2083 Sheet 8 "Cleanroom Suitability of Operating Materials"
31030.04.2003Changes in the Application Form for a Marketing Authorisation
30929.04.2003FDA's Risk-based Approach - Tools for Risk Analysis
30104.04.2003Risk Classification of GMP Deviations
30003.04.2003Annual Review 2002
29902.04.2003Warning Letters 2002: The Top 10 Complaints Regarding 21 CFR ž 211
29426.02.2003FDA Withdraws All Part 11 Guides and Publishes a New Draft
29325.02.2003MRA between EU and Canada Came into Force on 1 February 2003!
29224.02.2003Revision of the PIC/S Document PH 4/93 on the Preparation of a Site Master File
28917.02.2003ISPE's White Paper on "Risk-Based Approach to 21 CFR Part 11"
28815.02.2003Revision of the EMEA Guideline on Stability Testing of Existing Active Substances and Related Finished Products
28714.02.2003FDA Withdraws Part 11 Guide!
28203.02.2003Social Events
27813.01.2003PIC/S Recommendation on Sterility Testing Revised
27710.01.2003HPLC in FDA Warning Letters

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