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Seminar Price Details

18
Days Left To REGISTER
Seminar Fee for One Delegate
Price : US$1,199.00

Register for 5 attendees
Price : US$5,995.00

Register for 10 attendees
Price : US$11,990.00



**Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar.
  • Course Description
  • Agenda
  • Price
  • Speaker
  • Venue

Overview

This course is designed for people who are growing in their knowledge of sterile product production. It will be a "how to" course where the instructor will explain the reasoning as well as the procedures that should be used to process sterile products. The instructor will present different areas of study and present them with a practical approach so that the participant can see how the subject matter applies to the participant's work either now or in the future.

In addition to discussing the particular subjects the instructor will explain how pharmaceutical regulatory requirements are met through the use of aseptic techniques. The instructor has decades of experience in working with and within the regulated pharmaceutical industry in the U.S. He will be covering topics that he is familiar with and will present them in a manner aimed at workers who may have not been trained in sterile product production, but now wish to expand their level of understanding.

Why you should attend

Working in and with an aseptic area requires a certain mental attitude among those responsible for the manufacturing of sterile medicinal products. This course will help workers to develop that mind set, by learning about the tools and methods that are used by manufacturers who specialize in the production of such products. This will be especially useful for those who lack formal training in microbiology, as the reasoning underlying the procedures will be presented.

Agenda

Day 1 Schedule

Lecture 1: Definitions

  • Terms related to cleaning
  • Terms related to sterilization
  • Legal terms

Lecture 2: Personnel

  • Selection of workers
  • Training
    • Personal hygiene
    • Clothing procedures
      • Gowning
      • Gloving
      • Facial and head covering
    • Work procedures

Lecture 3: Sterilization Methods A

  • Heat based methods
    • Moist heat
    • Dry heat
  • Filtration methods
    • Bubblepoint testing
  • Parameters used for measuring sterilization effectiveness

D. Lecture 4: Sterilization Methods B.

  • Fog and vapour methods
    • Formaldehyde
    • Hydrogen peroxide
  • Gasses
    • Ethylene oxide
    • Chlorine dioxide
  • Radiation
    • Ultra-violet light
    • Gamma rays
    • Electron beam
  • Measuring the effectiveness of sterilization

Day 2 Schedule

Lecture 5: The Facility

  • Equipment for personnel
  • HEPA filters
  • Surfaces and flooring
  • Isolators and biological safety cabinets
  • Differential air pressures and flow
  • Smoke tests and video taping
  • Facility bioburden

Lecture 6: Classifications

  • Room classifications
    • ISO classes
    • Biological safety levels
    • Beta-lactam antibiotics and high potency drugs
  • Environmental isolates

Lecture 7: Monitoring

  • Active and still
    • Active
    • Still
  • Personnel
    • Gloves
    • Gowning and protective clothing
  • Water for injection
    • Particles
      • Light scattering
    • Microbial
      • Direct counts
      • Filtration methods
  • Air
    • Particles
      • Light scattering
      • Impingers
    • Microbial
      • Direct counting
      • Impinger and still measures
  • Surfaces
    • Swabs and touch plates

Lecture 8: Microbiological Monitoring

  • Cultures
    • Media qualification
      • Types of media
      • Challenge organisms/indicator organisms
      • Use of environmental isolates
    • Rapid identification methods
      • ATP detection
      • Nucleic acid-based methods
      • Head space analysis
  • Facility and work room monitoring
  • Monitoring isolators and high classification areas
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Suite 216, Fremont, CA 94539, USA
US: (510) 962-8903
Zurich, Switzerland: +41 - 43 434 80 33

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Group participations

Get fabulous discounts by participating in groups of two or more.

No Attendees Discount
1 2 Attendees 10% off
2 3 to 6 Attendees 20% off
3 7 to 10 Attendees 25% off
4 10+ Attendees 30% off

To avail the above group discounts, all the participants should register by making a single payment

Call our representative TODAY on +41 - 43 434 80 33 to have your seats confirmed!

Steven S. Kuwahara

Founder & Principal,


Steven S. Kuwahara , Ph.D. is the founder and Principal of GXP BioTechnology LLC, a consulting firm that works in the areas covered by the GLP and GMP of drugs, biologics, and nutraceuticals. Steve has over 30 years of experience in supervising quality control laboratories, including an animal testing facility, and in performing GLP and GMP audits of internal and external testing laboratories . Steve has participated in the development of drugs and biologicals through all phases of clinical research and final product production.

Venue

Location: Kuala Lumpur, Malaysia
Hotel: Coming Soon