SEP 29, 2020 8:00 AM PDT

Microbial Quality Control in Manufacturing of Medicinal Products

Sponsored by: Sartorius
C.E. Credits: P.A.C.E. CE Florida CE
Speaker
  • CEO and Principal Microbiology Consultant Microrite, Inc.
    Biography
      Ziva Abraham is the President and Founder of Microrite, Inc., a California based firm providing high level technical consulting services. Ziva has over 35 years of academic, research, clinical and industrial experience in microbiology, and quality assurance. Ziva has received her Master's Degree in microbiology with a focus on Mycology and has conducted research on developing microbial Insecticides using entomogenous bacteria and fungi for her Ph.D. degree. Her career also includes founding and managing clinical laboratories for Maccabi Medical in Israel. She has consulted for and trained personnel from various industries in microbiology and aseptic techniques and methods. She uses her extensive experience to convey why assessing risk of microbial contamination should be at the forefront of any company that has products for human/veterinary use. Her experience in clinical laboratories has provided her with the framework to understand the effects of microbial contamination in products from a patient safety perspective.

    Abstract
    DATE:  September 29, 2020
    TIME:   8:00am PT, 11:00am ET
     
    There is a steady increase in FDA 483s related to microbiology. Though most are for sterile products, non-sterile and terminally sterilized products are also scrutinized by the regulators. These issues span from manufacturing, where systems are inadequate to control microbial contamination to laboratory operations where media, test method validations and testing is non-optimal. These 483 observations relate to procedural deficiencies, laboratory operations, aseptic manufacturing, environmental monitoring and cleaning and disinfection. These repeat observations point towards a lack of understanding of microbial contamination control as well as lack of a quality centric culture, business taking priority over compliance and patient safety, lack of knowledge and expertise which leads to misidentifying or ignoring risks.
    • Procedures related to microbiological quality control
    • Inadequate laboratory controls
    • Investigations not adequate
    • Environmental monitoring system deficiencies
    • Equipment and utensils are not maintained or cleaned at appropriate intervals
    • Deficient aseptic processing
    • Cleaning and disinfection program deficiencies
     
    Learning Objectives
    • Highlight that microbial contamination risks are tangible, and it is crucial to understand these risks at every stage of manufacturing of medicinal products. 
    • Without an adequate knowledge base and the use of science in microbial contamination risk assessments, these issues will persist. 
    • Learn where microbial control fails from FDA 483 observations and case studies presented in this session.
     
    Webinars will be available for unlimited on-demand viewing after live event.
     
    LabRoots is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E. ® Program. By attending this webinar, you can earn 1 Continuing Education credit once you have viewed the webinar in its entirety.
     
     
     

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