Course Description:

This two day course will help understand the systems, procedures and training required to manufacture product which is contamination free when aseptically produced or microbiologically controlled when terminally sterilized. Microbial contamination control should never be an afterthought. Managing and controlling microbial contamination starts with adequate Cleanroom or CER design, maintenance and monitoring of the controlled environment and microbial quality of components, raw materials, exipients and cleaning efficacy of facility and equipment.

Who will Benefit:

This course will benefit personnel who work in cleanrooms or controlled environments, those who release batches of sterile and non-sterile products.

  • Quality Assurance
  • Quality Control Microbiology
  • Manufacturing Supervisors
  • Manufacturing Operators
  • Auditors
  • Materials Management
  • Facilities Personnel

Course Outline:

Schedule for Day 1, 8:00 AM - 4:00 PM
8:00 AM to 10:00 AM
  • Understanding Cleanroom Contamination
  • Microbial contaminants from facility, personnel and other sources
10:00 AM to 10:15 AMBreak
10:15 AM to 11:00 AM Facility Design and Maintenance considerations for aseptic and non-sterile products
11:00 AM to 12:00 PM
  • Gowning requirements for aseptic and non-sterile products
  • Rationale behind gowning
  • Common gowning errors that lead to EM excursions and product contamination
12:00 PM to 1:00 PM Lunch
1:00 PM to 2:30 PM
  • Process related contamination in aseptic and non-sterile manufacturing
  • Process gases as source of contamination
  • Water quality
  • In adequate equipment and parts cleaning
1:00 PM - 2:30 PM Medical Device Regulations in Argentina, Australia, Brazil, India, and Japan
2:30 PM to 2:45 PM Break
2:45 PM to 3:45 PM
  • Laboratory design and operations to avoid false positive results
  • Segregating operations
  • Laboratory errors leading to false positive results
  • Equipment cleaning and maintenance
3:45 PM to 4:00 PM 483 discussions and Q&A
Schedule for Day 2, 8:00 AM - 4:00 PM
8:00 AM to 10:00 AM
  • Environmental Monitoring for aseptic and non-sterile products
  • Guidances and regulations
  • Changes to USP <1116>
  • Using a risk based approach when identifying sites and frequency of monitoring
  • Media and monitoring equipment choice using scientific rationale 
10:00 AM to 10:15 AM Break
10:15 AM to 11:00 AM
  • Investigating EM excursions
  • Identify false excursions before wasting time and resources
  • How to investigate a true excursion
11:00 AM to 12:00 PM
  • Interpreting and trending data
  • Use EM data trends to identify
  • Problem areas
  • Personnel behavior
  • Objectionable microorganisms
  • Risk to product
12:00 PM to 1:00 PM Lunch
1:00 PM to 2:30 PM
  • Combating microbial contamination in facility
  • Understand disinfectants before establishing a cleaning program
  • Myths and facts about disinfectants
2:30 PM to 2:45 PM Break
2:45 PM to 3:45 PM
  • Disinfectant qualification challenges when testing planktonic microorganisms and biofilms
  • Common methods used in industry
  • Execution challenges for each study
  • How to review and use study data to control microbial contamination in facility
3:45 PM to 4:00 PM 483 discussions and Q&A

Meet Your Instructor

Ziva Abraham
President at Microrite, Inc.

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.

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Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $200 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event.

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