Microbial Contamination Control Seminar: A Holistic Approach

A unique advanced course from Microrite's Practical Series Seminars / May 15-16 2012 -- San Diego CA USA

San Jose CA USA, (PresseBox) - Microrite Inc today announced details of its latest seminar, Microbial Contamination Control: A Holistic Approach which is scheduled for May 15-16 2012, in San Diego CA USA.

This comprehensive course will address all aspects of microbial control:

Understanding Cleanroom Microbiology
Role of facility design and maintenance in microbial contamination control
Personnel and material flows, gowning and aseptic techniques
Raw materials, exipient and in-process materials; contamination sources and control
Monitoring Contamination -- Understanding regulations and establishing a compliant EM program
Disinfectant choice and qualification
Points to consider when cleaning equipment and facilities

To register online click here

To download the seminar brochure click here

Which industries does this seminar apply to:

Industries that will benefit from this training are pharmaceuticals, biotech, medical device and other cleanroom related vendors.

Who will benefit:

Quality assurance, facilities, manufacturing, training and quality control microbiology personnel

Who will be teaching:

Ziva Abraham, CEO of Microrite, is a well-known microbial contamination control expert with 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 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 also established clinical laboratory systems in Israel. Microrite, Inc. is a consulting company based in San Jose CA that helps pharmaceutical, medical device and biotech companies.

Microrite focuses on helping companies with contamination control, microbiological quality control for sterile and nonsterile 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 also served on the editorial board of Pharmaceutical Microbiology Forum (PMF) Newsletter.

This in-depth 2-day course will cover many microbial contamination-related topics, including:

DAY 1

Understanding Microbial Contamination

Internal and external sources, types and quantity of Microbial contamination (bacterial and fungal)
Cleanroom Microbiology – Bacterial and fungal contamination and their proliferation methods
Types of human borne contaminations that can compromise aseptic operations

Facility Design Issues

The importance of adequate air flows, and pressure differentials considering the nature of operation
Appropriate cleanroom materials to effectively control contamination
Understanding personnel flow and materials flows in a multi product facility

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

Aseptic Techniques

Do's and don'ts when performing aseptic inside hood for conducting cell manipulations
Consequences of improper transfer methods and not following aseptic techniques during cell manipulations

Process Related Microbial Contamination

Raw Materials as a source of contamination
Evaluating and measuring contamination in utilities
Establishing critical control points in process and setting acceptance criteria
Common process failures that can contribute to microbial contamination
Understanding cleaning validation and effects of product or microbial cross contamination

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

Laboratory Operations

Laboratory design and flow
Laboratory cleaning
Good laboratory practices

DAY 2

Monitoring and Combating Microbial Contamination

Discussion on the various cleanroom classification schemes and environment monitoring regulations and guidances
Qualification of cleanrooms-important points to consider and common errors
Using a risk based approach how to establish a meaningful environmental monitoring program
Number of sites using regulatory guidance and risk based approach
Discussion on choice and evaluation of equipment for environmental monitoring
Frequency of monitoring
Microbial Identification, when it is necessary and why -- how to identify objectionable microorganisms
Challenges in establishing validity of microbial identification
Importance of trending data to assess risk to product
Establishing user requirements for electronic environmental monitoring systems
Discussion on phenotypic and genotypic microbial identification systems
Overview of the key components of EM Summary Reports
Environmental Monitoring related investigations; what and where to look for?
Case studies and discussion on HACCP principles to investigate excursions and assess risk
Discussion on current FDA 483 observations on environmental monitoring and data trending

Disinfectant Choice, Qualification and Disinfection Program

Disinfectants commonly used in the industry; modes, efficacy and toxicity
Understanding testing for manufacturers and industry
Disinfectant Qualification
Discussion on current industry trend for qualifying disinfectants -- What is expected from regulatory agencies and who is required to perform such studies
Tools to develop an effective disinfectant qualification program
Common challenges in drafting and executing Disinfectant Qualification protocols
Commonly observed deficiencies in Disinfectant Qualification studies that may lead to contamination or FDA observations
Cleaning procedures-points to consider when choosing disinfectants, establishing rotation of disinfectants, frequency of cleaning, flow of cleaning, and choosing right cleaning supplies considering the criticality of the surfaces to be cleaned
Challenges in Cleaning -- Understand the natures of surfaces and the role of supplies
Know the importance of chemical kill and physical removal of contamination
Discussion of FDA 483s related to disinfection and disinfectant qualification

Accommodations:

Microrite suggests Embassy Suites San Diego-La Jolla at 4550 La Jolla Village Dr, San Diego CA, if you need sleeping rooms for this event. The hotel is half a block from BioCom. A shuttle will be available from the hotel to BioCom if needed. Kindly contact the hotel directly at:

Embassy Suites San Diego - La Jolla
4550 La Jolla Village Dr
San Diego CA 92122
858-453-0400 phone
858-453-4226 fax

Sponsors:

Prudential Cleanroom Services and VWR

Microrite Inc

Microrite is a California-based company providing consulting services and training on pharmaceuticals, medical device, biotech and combination products. Microrite provides microbiology, aseptic techniques, quality control, quality assurance, process development, process validation, facilities, utilities and equipment validation services to a broad range of clients. Clientele varies from large established companies to small start-ups.

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