Analytical Instrument Qualification - AIQ URS, DQ, IQ, OQ, PQ in the QC Laboratory Lecturer: Ms. Karen Ginsbury Date: 6 August 2008 Location: Kfar Maccabiah, Ramat Gan Course Language: Hebrew

Category: Quality Duration: 1 - Day Course Hours: 8:30 - 17:00 Registration:  Price: 1,750 NIS + VAT Credit Points: 1 SKU: 08209

This one day seminar will review the USP Chapter on Analytical Instrument Qualification (AIQ) in the perspective of regulatory requirements (EU and FDA), guidance and expectations. Using a minimalistic approach, the workshop will provide means of assessing the risks associated with different instruments and tying in the amount of effort invested in qualifying the equipment to the actual use within the laboratory. Benefits to the Participants Increased awareness of recent guidance and regulatory expectations.  An opportunity for practical understanding of the requirements for Analytical Instrument Qualification and their translation into clear, concise protocols for ensuring that when new equipment is installed in the lab you get what you order and that it operates as intended. Issues to be covered Regulatory: GMP requirements for equipment and instrumentation controls EU GMPs 21 CFR part 211 FDA Guidance on Inspection of Quality Control Laboratories Terminology and Definitionsb Background to AIQ and Perspective relative to Analytical Methods Validation Qualification as a subset of Validation Methods Validation: ruggedness; robustness and the potential for a measuring instrument to affect the reliability of measurement Uncertainty in analytical measurement and why calibration alone is not sufficient System Suitability: if it passes why qualification as well? Preparing for AIQ The AIQ process User Requirement Specification (URS) and DQ Responsibilities Protocol writing Instrument Categories and the USP chapter AIQ: Performance and Approvals Review the USP Chapter IQ / OQ / PQ: what MUST be verified and how Software qualification and SOPs Approvals and Change Control Who should attend This course is suitable for Quality Control analysts, supervisors, team leaders, Quality Control Managers, validation personnel, Quality Assurance personnel with QC oversight or auditing QC, Analytical R&D personnel and any person involved in performing, reviewing or interpreting data generated by analytical Quality Control Laboratories. About the Speaker Karen Ginsbury, B.Pharm, M.Sc, MRPharmS, has over twenty years of experience in the pharmaceutical industry.  With a Bachelor of Pharmacy degree from the University of London (“The Square”) and a Master of Science in Microbiology from Birkbeck College, University of London, Karen started off with a well-rounded foundation in the basic skills appropriate to the pharmaceutical industry.  She has worked in industry for most of her career, initially in Research and Development at Smith and Nephew in England and then for seven years at Teva Pharmaceutical Industries, today the world’s largest generic manufacturer.  After leaving Teva, Karen set up her own consultancy company, PCI Pharmaceutical Consulting Israel Ltd which has been providing services to the pharmaceutical industry worldwide for the past 14 years.  PCI regularly works with pharmaceutical, biotech and API manufacturers to assist them in resolving compliance issues with regulatory authorities, in setting up, maintaining and upgrading or improving their quality systems, performing audits at vendors, contract manufacturers, laboratories as well as helping clients successfully prepare for FDA, Health Canada, EU and local regulatory inspections. Karen was responsible for setting up the compliance department at Teva and published a book on compliance auditing, still available in the USA, that was purchased by most of the multi-national pharmaceutical companies as well as by the US FDA. Karen regularly lectures around the world on quality topics and is renowned for her lively and engaging style of presentation.  She was winner of the Institute of Validation Technology’s “Presentation of the Year Award” in 2006 and their “Webseminar of the Year Award” in 2007. Karen is also an active volunteer in the Parenteral Drug Association (PDA) and is currently co-editing their Technical Report on GMPs for Investigational Products.