Category: Quality , Regulatory Affairs
Quality Product Review
Lecturer: Ms. Karen Ginsbury
Date: 26 May 2009
Location:  Kfar Maccabiah, Ramat Gan
Course Language: Hebrew
Duration: 1 - Day Course
Hours: 08:30 – 17:00
Price: 1,750 NIS + VAT
Credit Points: 1
SKU: 09265
This one day course will take an in depth look at the regulatory requirements (EU and FDA) for performing quality reviews in the context of Q10 – Pharmaceutical Quality System Guidance which requires Management Review and ongoing product and process performance monitoring, as well in the light of the draft FDA guidance on Process Validation that requires ongoing process verification.
Product Annual Review as performed by companies to-date will be a large part of the quality review but this course will review those additional elements that are required in order to remain current with updated regulations and expectations.
Benefits to the Participants
 At the end of this course participants will have an overall understanding of the topic of Product Quality Review in the context of ongoing verification of process and product performance.  The course will tie in with CAPA programs to provide an enhanced quality system.
Issues to be covered
  • The GMP regulations:
    • EU on Product Quality Review
    • US on Annual Product Review
  • Q10 – Pharmaceutical Quality System regarding
    Ongoing Process and Product Performance Monitoring
  • FDA Process Validation Draft guidance requirement for ongoing process verification
  • What industry is currently doing
  • Critical Quality Attributes and their inclusion in the review
  • Critical Quality Parameters and their review
  • Data trending (Use of statistics)
  • Validation, deviations and changes
  • Organizational Structure, escalation policy
  • SOPs
  • CAPA and Follow-up
  • Critical systems, support systems
  • Management involvement and commitment
    This course is suitable for any person involved in manufacturing, quality control, quality assurance, regulatory affairs, research and development, purchasing and any other discipline that interfaces with aspects of control of pharmaceutical production
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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