קטגוריה: איכות , הנדסה/אחזקה
Good Engineering and Maintenance Practices a Critical Element of the Quality System
GMP - תנאי אחזקה והנדסה נאותים – מרכיב קריטי של מערכת האיכות
מרצה: גב' קרן גינסבורי
תאריך: 28 אוקטובר 2013
מיקום הקורס:  כפר המכביה, רמת גן
שפת הקורס: עברית
משך הפעילות: יום לימודים מלא
שעות: 08:30 – 17:00
עלות: 1,950 ש"ח + מע"מ
נקודות זכות: 1
מק''ט: 13156
 
 
Engineering and maintenance practices are generally addressed in inspections through the site tour: “rusty and poorly maintained equipment; non-calibrated instrumentation; unsuitable equipment or facility design and the like.  With the finalization of the FDA process validation guide, the first stage of process validation is defined as the “Design phase.”  FDA ties in the design of product with the process design and specifically mentions engineering as one of the functions that needs to be involved.  This one day course will review best engineering and maintenance practices to comply with current GMPs.
Benefits to the Participants
At the end of this course participants will understand the GMP requirements pertaining to facility and equipment design including application of risk management principles – in particular the concept of “harm” and how maintenance activities could cause harm to a process, qualification, maintenance and ongoing control including record-keeping requirements, record review and CAPA activities.
Issues to be covered
  • Regulation of engineering and maintenance activities including: recent inspectional issues
    • GMP requirements: Europe vs. USA (FDA)
    • Relevant guidances:
      • Process validation (facility, equipment, utilities)
      • ISPE baseline guides
      • ISO guide for cleanroom testing
      • WHO guidance
      • ICH Q9 Risk Management concepts
        • Prevention of harm during maintenance activities
      • ICH Q10 Concept of an effective quality system:
        • maintenance and engineering aspects
        • change control
        • ongoing process performance monitoring
  • Record-keeping:
    • Design documentation
    • Qualification and validation protocols
    • Calibration
    • SOPs for preventive and breakdown maintenance
    • Equipment / system logbooks
  • Record Review, CAPA, Statistics and Follow-up
    • Using review as a tool to allow follow-up of repeat malfunctions or poor corrective actions
    • Statistics: frequency of malfunction as a trigger for preventive replacement / upgrade; tie-in increased repairs with increased usage and alter preventive schedules as needed etc.
    • Review effectiveness of corrective actions and report to management to ensure budgeting for planned replacement
    • Identify critical services, equipment, and ensure redundancy and uninterruptable power
    • Maintaining a state of control and change management
Who should attend
This course is suitable for any person involved in Engineering, Maintenance, Operations, Quality Assurance and Quality Control and any other function in the company that interacts on a regular basis with those disciplines.  R&D personnel involved in product and process development will benefit from understanding many of the concepts to be addressed in this course.
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.

 


  • שם מלא
  • דוא''ל
  • טלפון
  • הודעה
שלח