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Over the last five years or so, the Quality Control Laboratory (one of the six systems in the novel FDA inspection model) has consistently featured at the top of the deficiency lists in regulatory inspections. Sample log-in, OOS results, analytical standards are just a few of the issues that lead to warning letters or inspectional observations. Our lecturer, Karen Ginsbury has won an international award for her lectures on the topic of GMP in the Laboratory. This is a chance to benefit from her world-wide experience so as to up-date and minimize the chance of adverse inspectional outcome in your laboratory.
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| Benefits to the Participants |
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Updates regarding the requirements in this topic
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Understanding how to transform regulatory requirements into laboratory Standard Operating Procedures, Test Methods and Operating Instructions that are controlled documents, implemented and performed by qualified and competent analysts.
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Implementations of insights that lead to minimizing the chance of adverse inspectional outcome
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| Issues to be covered |
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| Who should attend |
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This course is suitable for any person involved in Quality Control, Quality Assurance, Methods development intended for transfer to QC, methods validation and any other function in the company that interacts on a regular basis with the Quality Control Laboratory.
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| 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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