Understanding PCR and Mycoplasma Testing
LOCATION:Attend Live Webinar
DATE: 13-Dec-2016 : 1:00 PM EST
DURATION: 60 Mins
Speaker : Erika L. Roberts, M.F.S
Erika L. Roberts, M.F.S, is a Masters in Forensic Science (with an emphasis in document examination) and currently works as a Senior Quality Assurance Analyst and as a freelance consultant for the pharmaceutical/biotech industries. Having over more than a decade of experience working in many different areas of the pharmaceutical and biotech manufacturing quality environments, Ms. Roberts is uniquely qualified as a subject matter expert for sterility testing and microbial identification trainings. Her extensive background in USP regulations and applications allows for a broad perspective and a depth of training not commonly found in the industry. In addition to her microbiological work, Ms. Roberts is also a qualified trainer for document reviews of several analytical chemistry analyses commonly used in many FDA regulatory laboratories.
Course Description:
The detection of mycoplasmas in human and animal cell cultures is mandatory for every cell culture laboratory. These bacteria are common contaminants and can persist unrecognized in cell cultures for many years. This can affect research results as well as the purity of cell culture products. The reliability of the mycoplasma detection depends on the sensitivity and specificity of the method and should also be convenient to be included in the basic routine of cell culture quality assessment. Polymerase chain reaction (PCR) detection is one of the acknowledged methodologies to detect mycoplasmas in cell cultures and cell culture products. Although the PCR offers a fast and simple technique to detect mycoplasmas, the method is also susceptible to errors and can produce false positive as well as false-negative results. Thus, the establishment and the routine application of the PCR assay require optimization and the inclusion of the appropriate control reactions. This training will cover sample preparation, DNA extraction, PCR run, the analysis of the PCR products, and applicable regulations. Discussion will also include information on how to avoid artifacts produced by the method and other errors that may occur. Established properly, PCR is a reliable, fast, and sensitive method and should be applied regularly to monitor the contamination status of cell cultures.
Course Objective:
To identify which facilities, personnel that are impacted by FDA guidelines on cell culture use and production
Become familiar with the different types of cell cultures used and mycoplasma species
Identify and become familiar with the PCR testing
Implementing and maintaining a Quality environment (QA recommendations) and hazardous material considerations
Familiarization with different testing protocols and how they impact product, raw material and in process
What is required for compliance
What are cell cultures and how are they used and tested
New technologies and PCR products and research
Course Outline:
Types and examples of mycoplasma detection products
Regulatory environment of cell culture production
Personnel trainings and evaluation recommendations
QA program and FDA regulations/recommendation impacts on PCR testing and cell cultures
New technologies and areas of research opportunities
Target Audience:
Biotechnology manufacturing personnel and support staff in the biotechnology/pharmaceutical technology industries
Quality Assurance personnel and support staff in the biotechnology/pharmaceutical technology industries
Quality Control laboratory personnel and support staff in the biotechnology/pharmaceutical technology industries
Finished product and medical device testing and manufacturing facilities
Environmental Monitoring Program manager and support staff in the biotechnology/pharmaceutical technology industries
Pharmaceutical and general contract laboratory companies/entities
General laboratory personnel and staff who do routine work a controlled manufacturing environment
Please Click here to Enroll & for more details
Regards,
Joshua
Training Manager
Email: [email protected]
Call us at : 1-732-7225220
Website: compliance.world