Overview:
This full day intensive program will teach proactive measures to prevent contamination, will provide knowledge of the origin, types and sources of contamination, to effectively remove, destroy or inactivate them. QSIT (Quality Systems Inspection Technique) approach will be taken to understand and address contamination control. This training may also be used as a guide to auditing microbiological aspects of manufacturing as well as auditing contract laboratories. Ownership, involvement, and continuous personnel; awareness of contamination potential are key elements to implementation of a successful program.

How You Will Benefit:
By the end of this course, participants will take away the following:

• Key concepts of an effective program for contamination control, which  translate into superior regulatory posture and reduction in the number of rejected batches or quantity of recalled product.
• Effectively designed contamination control programs, practical knowledge of how to to elevate the assurance of final product quality, and ultimately consumer protection.

Course Outline:
This full day course will cover the following main points:

• Understanding contamination challenges using the QSIT approach. Each subsystem will be addressed separately for contamination risks.
• Contamination Risk Assessment
• Using HACCP approach assessing probability, severability, and detectability of contamination will be discussed.
• Contamination Overview
  • Types of contamination
  • Sources, types and quantity of contamination, viable and non-viable
  • Cleanroom Microbiology – Personal hygiene
  • Types of human borne contaminations that can compromise aseptic operations
• Other practices to follow to prevent contamination of product
  • Understanding personnel flow and materials flow
  • Understanding disinfectants
  • Evaluating cleanroom contamination and assessing efficacy of disinfection
  • Environmental monitoring – points to consider
  • Environmental monitoring – importance of trending
  • What different disinfectants do and do not do
  • Setting up a disinfection program including choice, frequency, flow and rotation
  • Points to consider when setting up a cleaning program for
    • Laboratory
    • Hoods and Biological safety cabinets
    • Equipment
    • Incubators
    • Benchtops
• Gowning
  • Understanding the rationale behind gowning
  • Qualifying personnel for gowning
  • Types of gowns and what to look for
• Hoods and Incubators
  • Important points to consider when working in Laminar Flow Hoods or Biological Safety Cabinets
    • Checking operation, calibration, and maintenance
    • What and how to prepare to conduct operations in Laminar Flow Hoods and
      • Biological Safety Cabinets
      • Wipe down of components
      • Maintaining laminar flow
    • Techniques and ways to move about inside a hood to promote safe practices
• Aseptic Techniques
  • Dos and don'ts when performing aseptic inside hood for conducting tissue culture
• Housekeeping rules
  • General every day cleaning around the lab
  • Wipedown of items going into the lab
  • Wipedown of surfaces/centrifuges/spills/end of day cleaning
  • Managing outside cleaning personnel
  • Review of documentation
• Case studies and discussion on recent contamination related FDA 483 observations

Who Should Attend:
Quality Assurance, Quality Control, Validation, Manufacturing, Facilities, Engineering, as well as Research and Development Personnel. This training will also be beneficial for Cleaning and facility maintenance personnel.

Cost:
Full-day course
Cost: $200 (includes class, all class materials, and lunch)

Instructor Bio: Ziva Abraham
Ziva Abraham has over 25 years of academic, research, clinical and industrial experience in Microbiology, and Quality Assurance. She has trained personnel from various industries in microbiology techniques and methods. Ziva has received her Master’s Degree in Microbiology and has conducted research on developing Microbial Insecticides during her graduate studies working mainly with fungi. She has established clinical laboratory systems in Israel, and Microrite, Inc. a consulting company based in San Jose, CA that helps Pharmaceutical, Medical Device, and Biotechnology  Companies. Microrite focuses on helping companies with contamination control, microbiological quality control for sterile and non-sterile manufacturing, and Quality Assurance. Ziva has also developed “BACTISPELL” a microbiology spellchecker to spell check genus and species names of microbes and other microbiology related terms. She is a member of PDA, ISPE, AAMI, and PMF and is an active mentor for graduate students at Stanford University working through the American Woman in Science Organization (AWIS). She is involved in Expanding Your Horizons a program through the Math and Scientific Network to educate young girls about careers in science. Ziva served on the editorial board of Pharmaceutical Microbiology Forum (PMF) Newsletter.