Key2Compliance® - Courses, Seminars and information about GMP, QSR and GDP http://www.key2compliance.com/intportal.htm Key2Compliance® - Courses, Seminars and information about GMP, QSR and GDP http://www.key2compliance.com/images/k2c-r-le_250.gif http://www.key2compliance.com/intportal.htm We provide knowledge and information about CGMP and Quality Systems to the Health Care industry Play4GMP® - New GMP board game. Ideal for refresher training http://www.key2compliance.com/play4gmp.htm The GMP board game that tests and improves your GMP compliance, knowledge, attitude and awareness! Now for delivery. Wed, 25 May 2011 14:19:00 GMT The new revision of FDA Process Validation Guide have just been released http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070336.pdf FDA Guidance for Industry - Process Validation: General Principles and Practices, Rev 1 released. Tue, 25 Jan 2011 13:15:00 GMT New GHTF CAPA Guide for Medical Device http://www.ghtf.org/documents/sg3/sg3_n18.pdf Quality management system – Medical Devices – Guidance on corrective action and preventive action and related QMS processes. Tue, 04 Jan 2011 09:19:00 GMT New course: Procedures for Performance with Mr James L. Vesper http://www.key2compliance.com/cs5109.htm Standard operating procedures (SOPs) are a regulatory requirement but frequently, they aren´t as useful as they could – or should – be. Tue, 04 Jan 2011 09:19:00 GMT New course: Writing Incident and Deviation Investigation Reports with Mr James L. Vesper http://www.key2compliance.com/cs5110.htm Writing an investigation report is sometimes viewed as a «penalty» when something doesn´t go as planned or when an unwanted – or unforeseen – event occurs. Tue, 04 Jan 2011 09:17:00 GMT Concept paper on storage conditions during transport from The European Medicines Agency (EMA) http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2010/11/WC500099261.pdf Tue, 28 Dec 2010 09:52:00 GMT « New EU GMP Guide Draft of Chapter 5 "Production" http://ec.europa.eu/health/files/gmp/chapter5_pc11-2010.pdf Changes in 5.25, 5.26, 5.27 and 5.31 Tue, 28 Dec 2010 09:43:00 GMT « Draft Guidance for Industry: Medical Device ISO 13485:2003 Voluntary Audit Report Submission Program http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm212795.htm Tue, 28 Dec 2010 09:27:00 GMT « Concept Paper on the Revision of the Guideline on Process Validation http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/03/WC500075029.pdf This guideline is being reviewed in order to implement the concepts highlighted in the ICH Q8, Q9 and Q10 guidelines. Tue, 28 Dec 2010 09:25:00 GMT « Questions and Answers Guide » from FDA: Human Drug Recalls http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm221671.htm FDA answers common questions regarding procedures for Human Drug Recalls. Thu, 19 Aug 2010 08:49:00 GMT Proposal for EU GMP Guide including CAPA http://www.key2compliance.com/pdf/EUGMP_part1_draft20091118.pdf The European Commission has published a proposal for the revision of Chapter 1 of the EU GMP Guide to inlclude the contents of ICH Q10. More concrete instructions for the implementation can be found in the GHTF (www.ghtf.org) guide SG3(PD)/N18R8. It is proposed for medical devices but have a lot of useful information on how to implement a functioning CAPA system in a pharmaceutical company. Thu, 19 Aug 2010 08:41:00 GMT New FDA Guidance for Industry: Q8, Q9, and Q10, Questions and Answers http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM210822.pdf This document is intended to clarify key issues when implementing the Q8, Q9, and Q10 guidances. Wed, 7 May 2010 12:19:00 GMT New FDA Guidance for Industry: Standards for Securing the Drug Supply Chain http://www.fda.gov/RegulatoryInformation/Guidances/ucm125505.htm Standardized Numerical Identification for Prescription Drug Packages. Wed, 29 Apr 2010 13:01:00 GMT Quality Systems Handbook for Medical Devices http://www.key2compliance.com/intmeddevbook.htm Now we have our popular handbook for the Medical Device industry available in English. Wed, 21 Apr 2010 10:56:00 GMT New books http://www.key2compliance.com/intbooklets.htm • ICH Q8/Q9/Q10 with GMP and ISO 9001 references
• Basic statistics in QC-lab environment

]]> Wed, 3 Mar 2010 08:17:00 GMT ICH Q8, Q9 and Q10, Questions & Answers http://www.ich.org/LOB/media/MEDIA5783.pdf The ICH Quality Implementation Working Group have published additional questions to their Q & A document regarding the Q8, Q9 and Q10 guidelines. Fri, 26 Feb 2010 11:17:00 GMT