קטגוריה: איכות , אביזרים ומכשור רפואי (אמ"ר) Medical Devices
Quality System Regulation - QSR
מרצה: גב' קרן גינסבורי
תאריך: 30 בינואר 2006
מיקום הקורס:  כפר המכביה, רמת גן
שפת הקורס: עברית
משך הפעילות: יום לימודים מלא
שעות: 09:00 – 17:00
עלות: 1600 ש" ח+ מע"מ
נקודות זכות: 1
 
Quality System Regulation - QSR
 
 
The Course Objective is to review regulatory requirements for manufacture of medical devices.
The course will provide an in-depth understanding of the regulations including translating "what" to do into "how" to do it with case studies and hands-on examples.
The course will also include a review of FDA 483 observations.
Benefits to the Participants

• Understanding of the need for regulation of medical devices as well as what is required
• Gaining practical advice as to how to implement the regulations while still enabling product development and profitable production
• Learning to weigh the risks against the benefits when making changes and   deciding on product disposition after complaints, production deviations or adverse audit findings

Issues to be covered
• History of regulation of the device industry
• GMP and the QSR
• Scope of the QSR
• Quality System Requirements
• Design Controls
• Documentation Controls
• Purchasing Controls
• Identification and Traceability
• Production and Process Controls
• Acceptance Activities
• Nonconforming Practice
• Corrective and Preventive Actions
• Labeling and packaging controls
• Handling, Storage, distribution and installation
• Records
• Servicing
• Statistical techniques
• Review of the FDA's recent draft guidance on the quality assurance of combination products: devices and drugs together and the regulation of these types of products
Who should attend
• Medical device manufacturers – quality, production and regulatory managers and staff
• R&D, engineers and lab managers from the medical device industry
• Vendors of services, materials and components designated for the medical device industry
• Representatives from VCs - evaluators, project managers and accompanists of start-ups and medical device companies
• Sponsors, scientists, and developers, managers of Incubators and stat-ups
   
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.
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