קטגוריה: איכות
Out of specification results
תוצאות חריגות מהמפרט (OOS)
מרצה: גב' קרן גינסבורי
תאריך: 30 במאי 2007
מיקום הקורס:  כפר המכביה, רמת גן
שפת הקורס: עברית
משך הפעילות: יום לימודים מלא
שעות: 8:30-17:00
עלות: 1,750 ש"ח + מע"מ
נקודות זכות: 1
מק''ט: 07116
Out of specification results
 
 
In October 2006, FDA finalized its "Guidance for Industry: Investigating Out of Specification (OOS) Test Results for Pharmaceutical Production", EIGHT years after issuing the first draft.
Bioforum is happy to offer a one day course on the topic of  Out of Specification Results.
Course Objective
The objective of the course is to provide participants with an in-depth review of the topic of out of specification results including case studies from industry.
The course will address the following topics:
  • The Barr court case and the history of out  of specification results
  • The FDA guidance: 1998 guidance and 2006 final version
  • What types of tests does the guideline address and when is it not valid
  • The FDA guidance on inspection of quality control laboratories and OOS results
  • ICH Q7A and OOS results in the manufacture of Active Pharmaceutical
  • Ingredients (Drug Substance)
  • When is a result Out of Specifications / Out of Trend / Questionable
  • Failure of a control as opposed to failure of the test
  • Laboratory investigation
  • Hypothesis formulation and testing
  • New test vs retest
  • Are there valid reasons for retesting
  • Resampling vs retesting
  • Production Investigation
  • Retesting protocol: how many retests
  • Qualitative vs quantitative tests
  • Averaging of Results: valid or not
  • Reportable result
  • Transparency of reporting vs the QP or the Quality Unit (responsible for batch  release)

The workshop is designed to be lively and highly interactive with the opportunity for the audience to ask questions and to exchange views with other participants struggling with similar conundrums.  Case studies from the course leader's experience will be used to highlight how OOS results can be mishandled with disastrous consequences.
Breakout sessions will allow participants to work in small groups to discuss OOS scenarios and suggest possible solutions.
PREREQUISITES: A basic knowledge of GMP is desirable in order to achieve full benefit from the course although all key elements as they apply to handling OOS results will be covered during the course.
Rationale
This course will provide participants with tools for handling OOS results within their company.  An OOS procedure is an essential compliance tool in any pharmaceutical Quality Control Laboratory.  This workshop will enable participants to understand why the issue is so critical and how to handle different problems as they arise.
Who should attend
This workshop is suitable for persons who work in or manage Quality Systems, Quality Assurance, Quality Control, Regulatory Affairs, Compliance, QPs, in both pharmaceutical and biotech companies, finished product and API manufacturers.  The course is also appropriate for analytical R&D employees and contract laboratories who have to handle out of specification, out of trend or questionable results

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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