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| DBA Courses in USA and Puerto Rico |
DBA is launching a series of training courses in San Diego, California and San J
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| Good Autoclave Practice Course - "The Best Yet" |
Las
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| GMP A HUGE SUCCESS |
A few weeks ago we hosted a 4 day course on Pharmaceutical GMP in Manchester.
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| NSF International Acquires David Begg Associates |
FOR IMMEDIATE RELEASE
September 10, 2007
CONTACTS:
Greta Ho
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| GARY REES JOINS DBA |
We
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| ADDITIONAL GMP COURSE FOR 2007 |
Amsterdam in December
Numerous people have written to u
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| Closing Date for iPod Promotion |
Earlier this year we asked our client's to recommend a colleague to us and, if that colleague att
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| Proposed changes to Chapter 1 of Part 1 of EU GMP Guide |
The EU has published a proposed revision to Chapter 1 of Part 1 of the EU GMP Guide, "Quality Man
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| EMEA Publishes GMP Inspection Database |
The European Medicines Agency, EMEA, has published an analysis of regulat
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| QP Reunion |
12 & 13 July 2007 at the Hilton York Hotel
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| QP Module 2 - Med Chem, Nov 06 |
QP Module 2 - Medicinal Chemistry - 20 to 24 November 2006 - Y
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| Pure Steam and No Hot Air! |
'Good Autoclave Practice'
CLONTARF CASTLE, D
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| Sterile Products and English Wine - A Successful Combination! |
In late September we ran our ever-popular 'Sterile Products Manufacture' course at the Hilton Hot
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| FDA Quality Systems Guidance |
Final Version Published
On 29 September the FDA published the final vers
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| ICH Q1F Withdrawal |
The ICH guideline Q1F on Stability testing for Climatic Zones III and IV, was WITHDRAWN on 8 June
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| FDA Revokes Rule... |
FDA Revokes Rule on cGMP Exemption for Phase 1 Clinical Trial Medicines
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| ANNEX 19 TO EU GMP GUIDE OFFICIALLY PUBLISHED |
The final version of Annex 19 to the EU GMP Guide, entitled 'Reference and Retention Samples', ha
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| EMEA UPDATE GUIDANCE ON INVESTIGATION OF COMPLAINTS |
EMEA has revised Chapter 8 of Part 1 of the EU GMP Guide to add a requirement for manufacturers t
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| Update to EMEA Q&As on PAT |
The EMEA has just published an addition to their Questions and Answers on PAT, concerning process
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| Proposed Changes to EU GMP Annex 1 |
We have been expecting it for the past six months, but the European Commission is finally consult
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| Revised EU GMP Guide, Chapters 1 and 6 |
EMEA have, at last, published the final versions of the revisions to the
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| ICH Q8 and Q9 Reach Step 4 of the ICH Process |
The Q8 guideline 'Pharmaceutical Development' and Q9 guideline 'Quality R
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| UK Changes to Veterinary Medicines |
Changes to the UK’s system for administration and licensing of veterinary
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| NEW REQUIREMENTS FOR BRAILLE |
The website of the MHRA has a downloadable pdf document regarding the new requirements for Braille u
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| NEW EU GMP STRUCTURE |
The European Commission has now published the restructured Volume IV of the Rules Governing Medicina
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| EU Braille Guidance - April 2005 |
EU have issued guidance for the use of braille on packaging of medicines. The rule primarily applie
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| GCP Directive 2005/28/EC |
The GCP Directive 2005/28/EC has been published by the EU. This provides guidelines on GCP and expa
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| Change Control - Industry Survey |
David Begg Associates has run a number of highly successful internal and external courses on Change
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| EU Propose to Amend Chapter 3 of GMP Guide and Annex 14 to Define Requirements for Dedicated Facilities for the Preparation of Medicinal Products Derived from Human Blood and Plasma |
EU has announced its proposals to provide more detailed guidance on the requirements for dedicated f
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| GMP Requirements for Excipient Manufacture |
European Industry groups have prepared proposals for the application of GMP requirements for certain
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| Pharmaceutical Water Systems - 'WATER DOCTOR' SERVICE |
Would you like a FREE ASSESSMENT of your system's compliance and operational efficiency?
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| EMEA Published Concept Paper for a Guideline on Viral Safety Evaluation of Biotech Investigational Medicinal Products |
The Biotech Working Party of CHMP has released for consultation a concept paper entitled “Guideline
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| Danish Medicines Agency Requires Testing of Imported Investigational Medicinal Products |
A Notice released by the Danish Medicines Agency on 19 October 2004 requires that imported drugs for
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| MHRA Publishes New Guidance on Reporting of Defective Medicines |
In response to industry enquiries, MHRA has published new guidance on the requirements for reporting
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