Course Description:

Course "Microbial Contamination Control in Aseptic and Non-Sterile Manufacturing" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

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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Your Registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @

Payment is required before 2 days of the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. ( our parent company)

Cancellations and Substitutions:
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.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($200) will be transferred to any future ComplianceOnline event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available we will send the material after the conference is over.

In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Attendance confirmation and Documents to carry to the seminar venue:
After we receive the payment from the registered attendee an electronic event pass will be sent to the email address associated with the registrant before 5 working days from the seminar date. Please bring the pass to the venue of the event.

Conference photograph / video:
By registering and attending ComplianceOnline conference you agree to have your photographs or videos taken at the conference venue and you do not have any objections to use these photos and videos by ComplianceOnline for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline for any kind of claims arising out of copyright or privacy violations.


The RAPS Regulatory Affairs Certificate Program offers unique curricula to round out your regulatory knowledge and professional skills with a focus on medical devices and/or pharmaceuticals. Whether you are looking to gain a better understanding of the regulated health product industry or bolster your credibility and resume or curriculum vitae, the Regulatory Affairs Certificate Program is a valuable resource in your pursuit of professional advancement.

After completion of course "Microbial Contamination Control in Aseptic and Non-Sterile Manufacturing" RAPS certificate will be issued to attendee.

Media Partners



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Media Partner Benefits
  • Logo and company data on the event website.
  • Logo on the conference material distributed during the conference.
  • Media Partner’s brochure distributed along with conference material.
  • Logo on all the mailings before and after the event.
  • 10% discount to media partner's subscribers.

Media Partner to do
  • Banner (min 728x90 or 468x60) on the Media Partner website.
  • Insertion of the event in the event calendar, both printed and/or online.
  • Announcement article of the conference on the Magazine and/or Website.
  • Dedicated email blast to all subscribers of Media Partner.
  • Article on the Magazine and/or Website after the conference.


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