:: On-site Clean Room Microbiology and contamination control seminar plus Disinfectant Qualification Consulting
In 2006, we started a major upgrade to one of our 3M manufacturing operations that included a large multiple controlled environment facility design. We needed to establish a disinfectant qualification program for this new facility and needed expert help for training in the use, maintenance, sanitizing and monitoring of this new operation.
We hired Microrite for consulting services to guide us through the disinfectant qualification program. Ziva was instrumental in leading us to an understanding of the influence of various disinfectants on our cleanroom surfaces. With her help, we successfully completed this disinfectant qualification and applied this knowledge to our new cleaning program for this new facility. Qualifying appropriate disinfectants was the first step in developing an overall strategy for our new facility. In addition, we needed training from an expert to teach us the proper methods for cleaning, maintaining and monitoring our new area.
In early 2007, we brought Ziva to our manufacturing plant for two days of intensive training of our production workers, cleaning personnel, maintenance staff, supervisors, managers, technical support people and our Microbiologists. This two day course was broken down into several phases. First there was classroom training were we learned how clean operations work and why we need to clean, maintain and monitor them. In the next portion, Ziva lead the technical staff through a comprehensive review of the new facility. This included the work flow, the air handling system, an environmental monitoring protocol, critical control point’s assessment plus a strategy for effective cleaning procedures that would minimize the risk of contamination and maximize the cleaning efforts. The final phase of the course included hands-on cleanroom cleaning methods training with the cleaning staff. The supervisory staff and the technical and microbiology support staff were directly involved in this hands-on training phase.
Ziva was a significant contributor to the successful implementation and on-going operational excellence of our new controlled environment facility. Her contributions were very well received by 3M. Ziva has a unique way of impressing, energizing and leading people at all levels to a clear understanding of the important factors needed to operate a successful cleanroom or controlled environment facility.
Advanced Microbiology Specialist
Over the last three years we have sent a number of individuals to Microrite’s training seminars on Environmental Monitoring, Disinfection Qualification and Cleanroom Contamination Control. In addition Minntech has also sent representatives to the Advanced Course in Fungal Identification.
We have found these seminars and workshops to be of great value to our organization and to the continuing education of our employees.
Ziva Abraham is a recognized expert in the industry and her knowledge and expertise has provided us with the tools to ensure the high quality of our products and our manufacturing processes.
Ziva does an excellent job of presenting the information in a well organized and captivating fashion, I will continue to utilize and recommend Microrite’s Seminars and Workshops.
Howard R. Nelson
QA Laboratory Manager
“Ziva combines a deep knowledge and a love of Microbiology to make her course highly effective. Her delivery engaged every individual in the course I attended; that group included a wide range of backgrounds—engineers with no knowledge in microbiology, experienced microbiology technicians, group managers, and other microbiologists—all came away knowing new, relevant ways to approach environmental testing they are involved with and/or to manage testing by personnel responsible for environmental testing at their facilities. Ziva provides effective training, quickly adapting to the knowledge base of her audience in a rapidly paced, entertaining course.”
Top qualities: Personable , Expert , Good Value
Ziva, I am a Microbiologist and have been a fan of yours and will continue to be one due to the high level of respect that I have for your knowledge and integrity in the field of Microbiology. Your knowledge, experience, dedication, tutoring, and passion as a seasoned Microbiologist is unparallel and have shown in the quality of your seminars and lectures that I have attended.
Your seminars have helped built in me a very strong knowledge base in contamination control, environmental monitoring, disinfection, cleanroom design amongst others which has greatly helped me in my career advancement. I have and will continue to send my employees to your seminars and highly recommend your classes for Microbiologist and Non-Microbiologist alike.
Quality Systems/Microbiology Manager,
“Ziva and Microrite are Top-Tier. Her knowledge base of Microbiology and Quality are outstanding. She is focused on providing exceptional consultation services and training. Ziva and her Associates at Microrite stay current on the changing world of FDA/EU Regulations in order to provide the most up-to-date assessment of your internal Systems. She's a fantastic person and a boat-load of fun as well!! If your Company is in the market for excellent consultation services, Ziva and Microrite are the one for you.”
Mitchell Oertle , Sr. Manager, Materials and Clinical Supplies , Zosano Pharma, Inc.
“I first met Ziva in a conference she was giving on micro contamination for professionals in the Pharmaceutical/ Biotechnology world and I have not stopped working with her since. That was over five years ago and not only had she educated me with a wealth of knowledge but every Expert, Master, PHD w/ practical experience in the room had their heads spinning with new valuable content that they could put to use now. Ziva will bring the expertise you need from QA/ QC development to training your staff in practical applications they can put to work in your development and manufacturing right away. Ziva and Microrite are the consultants you should select.”
Myles Reukema , Director of National Sales , Prudential Overall Supply/ Prudential Cleanroom Services
:: Environmental Monitoring Seminar ::
I just wanted to take a second to let you know what an excellent seminar that was in Irvine. I found both presentations extremely valuable and full of pertinent information. Your credentials are impeccable and I am highly impressed with your experience and abilities. Thanks again Ziva, I feel energized on sanitation and EM and I am excited to streamline this process.
Quality Assurance Controller
Global Food Techonologies
I went to this seminar mostly to see if I was forgetting anything with my current process. The one major thing I got out of the seminar was the aspect of reporting.
Senior Chemist and Microbiologist
:: Consulting and Training ::
For the past three years, Ziva has consulted with me first at Embolic Protection Inc. (EPI), then when it was acquired by Boston Scientific Corporation, Boston Scientific/EPI in the areas of Controlled Environmental Rooms, sterilization, microbial bioburden, general microbiological control and personnel training.
Ziva has extensive experience in most of the areas of microbiology and its application to medical manufacturing for both pharmaceuticals and medical devices. Her troubleshooting knowledge in the area of solving microbiological problems is legendary.
Ziva was instrumental in helping us establish the certification requirements and program necessary for us to start manufacturing Class III medical devices with exceptionally low microbial bioburden counts. Part of this involved training management to deal with the problems associated with microbiology in the start up environment, and the other part was setting up programs to effectively deal with monitoring and educating everyone about microbiology in the CER environment. We had several major issues as we started and Ziva helped us work our way through them without mishap.
Ziva has assumed the role of an instructor and has held numerous training sessions in our facility. The response of the class is always very positive and management has decided to employ Ziva to regularly train CER employees in addition to conducting regularly scheduled audits of the facility and operations to continuously improve our facility.
It has been an honor and a pleasure to have Ziva take the time to assist us in building and developing a highly successful manufacturing operation.
Please feel free to contact me as a reference.
Director of Quality Assurance
:: Fungal Identification Workshop ::
"This course was time very well spent -- it focused on identifying fungal isolates from the environment, and covered a substantial amount of information in only one day. The instructor is so knowledgeable in the field that she makes the course as rewarding for the experienced microbiologist, as for the microbiologist just becoming familiar with the fungi. I am recommending the course to everyone in my laboratory."
Jane B. James, Ph.D.
Manager, QA Microbiology
:: Disinfectant Seminar ::
In May 2003, I attended your sanitization seminar with five members of the Clean Room Manufacturing staff. We were completely revising our disinfection program at the time, and the definitions and procedural outlines were very helpful in completing this project. The discussion on the challenges of disinfecting, including the nature of clean room surfaces, was especially helpful for my staff. The microscopic pictures of cleanroom curtains were amazing! They brought this knowledge back to the department and trained their peers on these issues. Overall, the seminar helped us to understand why we need to disinfect our cleanrooms properly and gave us the background to achieve that goal.
Thank you for offering this seminar,
:: Environmental Monitoring and Disinfectant Seminar ::
The seminar topics not only presented valuable background information on Environmental Monitoring Tracking /Trending and the Qualification of Disinfectants but also provided actual technical examples and solutions applicable to the specific needs of individual companies.
Thank you for a very worthwhile and educational seminar.
Manager, QC Microbiology
:: The Disinfectant Seminar ::
The seminar provided excellent insight into the world of cleanroom cleaning.
Particularly insightful was the section covering the nature of the surfaces being cleaned. Often times, during the actual process of cleaning, surfaces are inclined to react to disinfectants in different ways. Knowing the quality and consistency of a particular surface has added to my knowledge of how to clean problem areas.
Also informative were the sections dealing with storage and documentation. These are important and often overlooked features of any cleaning program and I feel that the seminar gave excellent attention to these extremely important issues.
Controlled Contamination Services
On-site Manager IDEC Pharmaceuticals (Oceanside)
This was what I consider good seminar. It made me think of our process and what we can do to improve it. Of course we could not do everything, but when you look at the overall picture, what it is we are doing to what needs to be done to eliminate the problem. One of the areas I enjoyed was how you talked about the different modes of actions/advantages/disadvantages of the disinfectants and then looking at what I was using. After the class, I reviewed our procedure and found that we did not have a complete cleaning system that I learned in the class.
Attending the seminar on Tracking and Trending Environmental Monitoring Results presented by Microrite Inc. was valuable and educational experience. This seminar provides the keys to develop a comprehensive environmental monitoring program through guidance in creating detailed procedures, functional databases and meaningful reports. I would recommend this seminar to those beginning to building an environmental monitoring program, in addition to those looking to reevaluate and improve their current methods.
:: On-Site Clean Room Microbiology and Contamination Control Seminar ::
I recently had the privilege of attending the Clean Room Microbiology and Contamination Control class presented by Zubeda Ziva Abraham of Microrite, Inc. I was delighted with the energetic and knowledgeable presentation. The material was complete and well organized, and Zivas personal examples made the connection to real world contamination control. As a non-biologist, I have gained a much greater appreciation of the world of bugs and how I have to deal with them. Thank you, Ziva!
Ziva Abraham of Microrite, Inc. has held training sessions in cleanroom microbiology and contamination control at our facility. The response of the class is always very positive and the seminars have helped cleanroom personnel and supervisors gain knowledge of the causes of contamination and methods to control it.
T. P. Lypka
Dir of QA/QC
Boston Scientific Corp.
Santa Clara, California
C1: Creativity - We believe that creativity, not additional capital, generates the most effective solutions. This is the reason why we use a risk based approach and quality by design approach in all our work.
C2: Communication - We have no secrets and give no surprises. We always will tell you what is happening and teach you everything we know. We communicate!
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