CAPA & Q10

Lecturer: Ms. Karen Ginsbury

Date: 19 December 2018
Location: Kfar Maccabiah, Ramat Gan
General Information
Duration: 1 - Day Course
Hours: 09:00 – 17:00
Price: 1,950 NIS + VAT
Credit Points: 1
SKU: 18137
Course Language: Hebrew
About the Course
Who should attend
CAPA & Q10
Benefits to the Participants
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Issues to be covered

Corrective and Preventive Action (CAPA), is a “well-known pharmaceutical concept” according to FDA’s quality systems guidance (2006). Actually the concept, while well-known in the medical device industry and through ISO certification systems, has been notably missed in pharmaceutical GMPs to-date.  The recently issued ICH Q10 guidance, addresses four specific pharmaceutical quality system elements that augment GMPs to achieve the objectives of a modern, successful and effective quality system.
This course will look at what CAPA really is, how information is gathered and fed into the system and how issues are investigated to address root cause and resolve the issue, preventing recurrence.
This course will help your company develop an escalation policy (addressed in Q10) to take unresolved items through the management hierarchy to ensure resolution.

Benefits to the Participants
  • Understanding how a CAPA system forms one of the four pillars of a quality system and how to conduct effective investigations of defects and deficiencies in the quality system. 
  • A clear understanding of the difference between corrective as opposed to preventive actions will be achieved.
Issues to be covered
  • CAPA and its roots in ISO
  • ICH Q10 – Pharmaceutical Quality System: the need for enhancing GMP with a global guidance
  • CAPA = 25% of a quality system
  • What constitutes a deviation or identified deficiency in a quality system
  • Corrective Action
  • Preventive Action
  • Investigations:
    • when are they NOT needed
    • how to conduct an investigation
    • how to document an investigation
    • conclusions as opposed to findings (facts)
  • Managing a CAPA system: manual vs computerized (part 11 compliance?)
  • Escalation process (SOP) for resolving tough issues
Who should attend
VP Operations, Production Managers, Quality Unit Directors, VP Quality, VP QA / RA, Quality Unit Supervisors, RA personnel, personnel involved in product development, Operations and Production personnel and Supervisors, Laboratory personnel and any other person involved directly or indirectly in compliance and quality related activities.
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.
About The Lecturer

Ms. Karen Ginsbury

Karen Ginsbury is a London, UK trained pharmacist with a second degree and passion for microbiology. With hands-on experience of cleanroom management, Karen has over 27 years of experience in the pharmaceutical industry working at setting up, implementing and continuously improving quality systems. Karen is an experienced risk management facilitator as well as a lively and highly interactive lecturer.
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