Courses Process Validation Both the FDA Quality System Regulation, 21 CFR Part 820, and EN ISO 13485:2003 include requirements for process validation. Many manufacturers have not established compliance with the regulation in relation to process validation satisfactorily and have therefore received adverse FDA inspections, including issuance of Warning Letters and Import Alerts. The course is designed to ensure delegates fully understand the essential business and regulatory requirements for process validation. The programme is supported by the use of two case studies. For more information about the course and registration see www.ds.dk/4208. Date: 30 September 2008 Medical Device Design and Development Control The FDA Quality System Regulation 21 CFR Part 820, and EN ISO 13485:2003 both contain significant requirements in relation to design control. In many cases manufacturers have not satisfactorily established compliance with the regulation and standard and have received adverse inspections, including issuance of FDA Warning Letters and Import Alerts. In practical terms, good design control results in timely, cost-effective design projects which deliver safe and effective medical devices to the market place. The objective of the course is to give the delegates the most up-to-date information in relation to design and development control requirements as defined in the FDA Quality System Regulation and EN ISO 13485:2003. For more information about the course and registration see www.ds.dk/4207. Date: 1 October 2008 EN ISO 13485:2003 compliance - a strategic decision The objectives of the course are that you will become familiar with the text of ISO 13485:2003, and by the end of the last session for you to feel confident that you know your way around it.You will be guided through the new text and the requirements and there will be case studies to aid in understanding of what is new and to give some practice in finding the relevant provisions. For more information see www.dscert.dk/da-DK/ydelser/Kurser/Sider/VisKursus.aspx?CourseId=11 Date: 7-8 October 2008 The Updated MDD - what's new? On 5 September 2007 the revision of Directive 93/42/EEC on medical devices was published. What is new and what are the implications of the changes for manufacturers and distributors of medical devices? Sign up for this 1 day course now and get familiar with the changes and their implications. For more information about the course and registration see www.ds.dk/4129. Date: 7 October 2008 Compliance with the In Vitro Diagnostic Medical Device Directive (98/79/EC) This course is designed to give you an understanding of the requirements of the In Vitro Diagnostic Medical Device Directive (IVDD 98/79/EC). At the end of the course, you will be able to implement the requirements of the Directive and to audit organisations against it. The course is held in English. For more information see www.ds.dk/3915. Date: 8-9 October 2008 Establishing Compliance with ISO 11135-1:2007 for Validation of Ethylene Oxide Sterilization Whether ethylene oxide sterilization is performed in-house or with a contract sterilizer the product manufacturer must be informed as to the process validation and process control requirements associated with the sterilization process. The course is designed to ensure delegates fully understand the new and revised requirements contained in ISO 11135-1: 2007, which is a major revision of the 1994 version of the standard. For further information about the course and registration see www.ds.dk/4209. Date: 21 October 2008 Establishing Compliance with ISO 11137-2:2006 for Validation of Radiation Sterilization Whether radiation sterilization is performed in-house or with a contract sterilizer the product manufacturer must be informed as to the process validation and process control requirements associated with the radiation process. The course is designed to ensure that delegates fully understand the new and revised requirements contained in EN ISO 11137-2:2006 which is a major revision of the 1994 version of the standard. For more information about the course and registration see www.ds.dk/4206. Date: 22 October 2008 Biocompatibility Testing of Medical Device This course is designed to give you an overview of the EN ISO 10993 standard with all its different parts and give you input on how to apply the standard for effective biocompatibility testing. The course aims at familiarizing you with why different tests are necessary, which tests can be useful as screening and how to get as much information as possible out of the test program if tests are combined or slightly modified. For more information about the course and registration see www.ds.dk/4201. Date: 23 October 2008 Risk Management for Medical Devices according to the ISO 14971:2007 The course will give a basic introduction to the requirements on Risk Management according to the ISO 14971:2007. The course will also give tools and practical examples (work shop) on how to comply with the requirements. The course language will be English. For further information see www.ds.dk/3914. Date: 11 November 2008 FMEA/FMECA for medical devices FMECA is an important tool to identify potential failures of a product. Through a structured methodology, you will review every aspect of a product design or a product process like manufacturing, warehousing or shipping. The potential failure modes will lead to a series of activities ending up with product or process improvements. For more information about the course and registration see www.ds.dk/4042. Date: 12 November 2008 Internal Auditing Against EN ISO 13485:2003 - Improving our Effectiveness On this course you will be familiar with the auditing process in relation to the EN ISO 13485 standard. Emphasis will be on the specific requirements of EN ISO 13485 and you will learn what to look for when auditing against this standard. For more information about the course and registration see www.ds.dk/4139. Date: 17-18 November 2008 Compliance with the Medical Device Directive 93/42/EEC (MDD) The course is designed to give you an understanding of the requirements of the Medical Device Directive (MDD 93/42/EEC). At the end of the course, you will be able to implement the requirements of the Directive and to audit organisations against it. For more information about the course and registration see www.ds.dk/4075. Date: 19-21 November 2008 Improving CAPA and Root Cause Analysis (in-house course) This course is designed to show how compliance with the requirements for CAPA can be improved. It also provides information on what makes people poor problem solvers and what simple but effective techniques can be deployed to improve root cause analysis. The course is only available as an in-house course. For more information see www.ds.dk/4205. Date: xxxx-xx-xx