קטגוריה: איכות , אביזרים ומכשור רפואי (אמ"ר) Medical Devices , ייצור , מו"פ , ניסויים קליניים , פרמצבטיקה/תרופות/מוצרים ביולוגיים , רגולציה - תקינה
Phase Appropriate GMP for Investigational Products
GMP בייצור מוצרים לניסויים קליניים
מרצה: גב' קרן גינסבורי
תאריך: 17 מאי 2012
מיקום הקורס:  כפר המכביה, רמת גן
שפת הקורס: עברית
משך הפעילות: יום לימודים מלא
שעות:  09:00-17:00
התכנסות והרשמה: 09:00 - 08:30
עלות: 1,950 ש"ח + מע"מ
נקודות זכות: 1
מק''ט: 12248
 
 
Any pharmaceutical product intended for human use should be manufactured under “full” GMP…or should it?  What is “full” GMP and which elements of GMP can actually be applied and are appropriate for the different phases of clinical trial material production.  This course will address phase specific GMPs to allow a risk based approach to manufacture of safe product for human use in manageable time frames and cost.

Annex 13 of the EU GMPs, which has just been issued in a revised version, will be incorporate  into the course material
Benefits to the Participants
At the end of this course participants will understand how to apply risk management tools to designing an appropriate quality system for manufacture of investigational products that are compliant with regulatory filings as well as with relevant parts of the GMP regulations.
Issues to be covered
  • The GMP regulations:
    • EU and US on manufacture of investigational products
      • US exemption for phase 1 material
      • EU application of all of the GMPs including Annex 13 for investigational products
  • Q10 – Pharmaceutical Quality System phased approach to quality system for investigational product manufacture
  • Introduction to regulation of investigational products: IND vs CTA / IMPD in Europe and regulatory commitments
  • Quality contracts / technical agreements with third parties:
    • Contract laboratories
    • Contract manufacturing organizations
    • Contract packaging and distribution organizations
    • Supplier qualification
  • Analytical methods development and qualification vs validation
  • Cleaning validation vs verification
  • Process qualification / verification / repeatability vs process validation
  • Is product quality review necessary for investigational product
  • Deviations, change management and CAPA
  • Management review

Who should attend
This course is a must for any person involved in manufacturing, quality control, quality assurance, regulatory affairs, research and development, purchasing and any other discipline that interfaces with the development of investigational medicinal products
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.
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