קטגוריה: איכות , מיקרוביולוגיה
The Microbiology of Environmental Monitoring - EM
מרצה: גב' קרן גינסבורי
תאריך: 7-8 בספטמבר 2005
מיקום הקורס:  כפר המכביה, רמת גן
שפת הקורס: עברית
משך הפעילות: 2 ימי לימודים מלאים
שעות: 09:00 – 17:00
עלות: 3,200 ש"ח + מע"מ
נקודות זכות: 2
מק''ט: 1
The Microbiology of Environmental Monitoring - EM
 
 
The goal of the course is to provide a novel insight into managing the microbiology of an environmental monitoring program. Any controlled environment / clean room needs to be actively monitored to verify that the HVAC system is functioning correctly and that personnel practices and cleaning and sanitization procedures are effective. The objective of this course is to take a look at the EM program from the perspective of a microbiologist, providing insight into microbiological concepts, reviewing types of contamination and discussing identification methods and practices.
Benefits to the Participants
  • Perform an initial assessment of a supplier's suitability for use in their company
  • Differentiate between supplier / manufacturer and site of manufacture per material / component and prepare a list of approved suppliers
  • Prepare / define quality elements of a supplier contract udit a supplier and / or manufacturer of raw materials or components
  • Prepare a procedure for supplier approval including management of change and differentiate between introducing new materials for product development to making

What you will learn:
This course will provide participants with a new perspective on the importance of microbiology in a controlled environment. Participants will leave with an understanding of the inherent dangers of micro-organisms, the usefulness of a well-designed EM program and how to utilize the data that the program generates as a preventive feed-back mechanism for pro-active measures that reduce microbiological data deviations.

Issues to be covered
  • GMP requirements for Environmental Monitoring
  • Guidelines and guidances as well as useful references on the topic of environmental monitoring programs
  • Basic classic microbiology: what is morphology and how much can you learn about an organism by looking (and smelling) the colony
  • Risk assessment methods for deciding where and how extensively to monitor the environment: determining sampling frequencies
  • Different dosage forms and the inherent microbiological dangers associated with each type:
    • Oral solid dosage forms: tablets and capsules
    • Oral liquid dosage forms: solutions and suspensions
    • Creams and ointments
    • Rectal dosage forms
    • Inhalations
  • Parenteral drugs: terminally sterilized / aseptic processing
  • Microbiological methods for sampling the environment
  • Growth promotion using pharmacopeial organisms as well as strains isolated from your environment
  • How much identification of organisms and how to select: genus or species level
  • Maintaining a library of micro-organisms
  • Methods of identification: classic vs rapid methods / genotypic vs phenotypic
  • What to do with microbiological data deviations (MDD - NOT OOS) and trending results
  • What is a corrective action to an MDD

The workshop will take the form of interactive lectures with leading questions posed to encourage the audience to develop their pre-existing knowledge of the topic.

Interactive excercises will review data and identify trends as well as assessing the significance of particular organisms isolated from different environments 

Who should attend
This course is suitable for persons from Quality Assurance, Production, Quality Control, Compliance, Regulatory Affairs, Microbiologists, Technicians, Supervisors, Department Heads, Team Leaders and Managers responsible for development, implementation, overseeing, sampling and testing for an environmental monitoring program.
   
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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