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 Nouvelles publications 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 New courses about Cleaning Validation and the new EU Annex 1 (Manufacture of Sterile Medicinal Products) http://www.key2compliance.com/cs.htm "Cleaning Validation - Strategy, techniques and regulations" March 23-24, Malmö, Sweden and May 19-20 Stockholm, Sweden.
"The new Annex 1 of EU GMP – interpretations and applications" March 25, Malmö, Sweden and May 21 Stockholm, Sweden

]]> Fri, 26 Feb 2010 11:17:00 GMT New course: Best Practices for Global Investigational Medicinal Product (IMP) Management http://www.key2compliance.com/cs5219.htm How to improve the quality and cycle times by means of smart project management concepts, use of modern technologies and practical approaches in the frame of global GMP regulations. 17-18 May 2010, Stockholm, Sweden Tue, 12 Jan 2010 14:55:00 GMT Webinar: Recommendations on how to implement ICH Q9 and Q10 http://www.key2compliance.com/cs4812.htm Quality Systems and Quality Risk Management is relatively new to the pharmaceutical industry. Guidances have been published from the regulators and EMEA is currently working on revisions of EU GMP Part 1 to incorporate the Q10 principles. This webinar will give you ideas and recommendations on how to start and what to consider. 25 february 2010, 10.00-12.00 Fri, 18 Dec 2009 09:20:00 GMT Changed date: Handling foreign inspections in a multicultural environment http://www.key2compliance.com/cs5107.htm The presenters will share information that may help API and Dosage form manufacturers to prepare for foreign inspections. With good preparation you can avoid time-consuming follow-up and unnecessary misunderstandings. April 27, 2010 in Copenhagen Fri, 18 Dec 2009 09:15:00 GMT New proposed GMP rule for Combination products http://edocket.access.gpo.gov/2009/E9-22850.htm FDA proposes a new rule CFR 4 (Subpart A) to clearify which cGMP requirements apply when drugs, devices, and biological products are combined in a Combination product. Mon, 5 Oct 2009 14:13:00 GMT The GMP Handbook - quality systems for the pharmaceutical industry http://www.key2compliance.com/intgmphandbook.htm Anna Lundén has gathered her experience from thousands of GMP training hours in the pharmaceutical industry in this clear and easy to read book. Mon, 14 Sep 2009 11:30:00 GMT New FDA Guidance for Industry - Pharmaceutical Components at Risk for Melamine Contamination http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM175984.pdf FDA have seen that food and Pharmaceutical products derived from milk are at risk for being contaminated with melamine. This guide covers requirements and recommendations for testing and control of the manufacturing/supply chain monitoring as well as a list of at-risk pharmaceutical components. Mon, 14 Sep 2009 11:35:00 GMT