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Contamination Control: A Holistic Approach
June 4, 2019
Contamination Control: A Holistic Approach

This half day workshop will provide a practical approach to understanding and preventing contamination in medicinal products. Sterile, non-sterile and terminally sterilized products each have different challenges in relation to microbial and particulate contamination. If addressed upfront by exploring real world risks versus perceived risks, contamination can be prevented.
 

By comprehending the degree of harm contaminants can inflict upon the patient, preventive actions can be implemented at each phase of manufacturing to mitigate product contamination. Developing a holistic contamination control strategy with process knowledge is key for avoiding contamination events and dire consequences. This contamination control strategy should define risk control measures (technical and organisational) in support of quality risk management (QRM).
 

FEATURED SPEAKERS

Ziva Abraham

Ziva Abraham

CEO, Microrite, Inc.

Ziva Abraham

CEO, Microrite, Inc.
Ziva Abraham

Ziva Abraham is the President and Founder of Microrite, Inc., a California based consulting firm providing consulting and training services to pharmaceuticals, biotechnology, medical devices and in vitro diagnostics in the areas of quality assurance, quality control, microbiology, and validation.
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 PhD degree. Her career also includes founding and managing clinical laboratories for Maccabi Medical in Israel. She has trained personnel from various industries in microbiology techniques and methods. She uses her extensive experience to teach why assessing risk of microbial contamination should be in 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.
 

Workshop agenda

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8:30

Registration & Coffee

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9:00

Workshop leader introduction

Ziva Abraham, CEO, Microrite, Inc.

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9:10

Understand contamination challenges in each type of medicinal product

Ziva Abraham, CEO, Microrite, Inc.

  • Learn to evaluate the sources of these contaminants and how they can be prevented
  • Learn from case studies
  • Common facility design and integration flaws that can lead to contamination and data integrity

     

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    9:50

    Common errors made during qualification

    Ziva Abraham, CEO, Microrite, Inc.

  • Gaps in environmental monitoring that can lead a to false sense of environmental control
  • Learn from personnel gowning related 483 observations and avoid gown choice and management issues

     

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    10:30

    Morning Coffee

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    11:00

    Dispel myths about cleaning and disinfection

    Ziva Abraham, CEO, Microrite, Inc.

  • Understand process related risks
  • Learn how to control contamination in the laboratory and avoid unreliable data
     
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    11:40

    Guidance of drafting a contamination control strategy

    Ziva Abraham, CEO, Microrite, Inc.

    Group Exercise: Workshop leader will select a product type and lead discussions on what contamination control steps should be taken in terms of facility, gowning, cleaning and testing.

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    12:20

    Closing remarks

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    12:30

    End of workshop


    CEO
    Microrite, Inc.

    Hyatt Regency Mission Bay

    1441 Quivira Road
    San Diego 92109
    USA

    Hyatt Regency Mission Bay

    Experience the epitome of California coastal chic at Hyatt Regency Mission Bay Spa and Marina San Diego vacation resort near SeaWorld San Diego. Expect the best at this remarkable San Diego vacation resort offering incredible ocean views, waterfront dining, a contemporary poolside lounge, eco-friendly spa, and redesigned hotel rooms and suites and meeting rooms. The only resort hotel in San Diego with multiple water slides, you'll delight in a water playground with three new pools, waterfront health club, and a full-service marina with jet skis, sailboats, kayaks, sportfishing and whale excursions.

    An unparalleled choice for discerning travelers, you’ll find everything you could wish for at our premier Mission Bay hotel near famous San Diego,CA attractions such as SeaWorld San Diego.

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    WHAT IS CPD?

    CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

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