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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).
 

A documented contamination control strategy is not an option; it is a requirement per GMP Annex 1 revision.
 

Contamination control should commence with facility design and end with product shelf life. Contamination of a product can occur due to the environment, equipment, process and/or personnel. If not thought through utilizing a good scientific rationale and properly documented; contamination control strategies can be lost in day to day operations. This half day practical workshop will teach, through case studies, how to address risk at each step of manufacturing. It will also impart strategies on how to take appropriate measures which then can be documented in the contamination control strategy.
 

Additionally, this policy can become a living document for proactive actions instead of reactive chaos.
 

Workshop programme

8:30 Registration & Coffee

9:00 Workshop leader introduction

Ziva Abraham

Ziva Abraham, CEO, Microrite, Inc.
View Bio

9:10 Understand contamination challenges in each type of medicinal product

Ziva Abraham

Ziva Abraham, CEO, Microrite, Inc.
View Bio

  • 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

     

  • 9:50 Common errors made during qualification

    Ziva Abraham

    Ziva Abraham, CEO, Microrite, Inc.
    View Bio

  • 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

     

  • 10:30 Morning Coffee

    11:00 Dispel myths about cleaning and disinfection

    Ziva Abraham

    Ziva Abraham, CEO, Microrite, Inc.
    View Bio

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

    Ziva Abraham

    Ziva Abraham, CEO, Microrite, Inc.
    View Bio

    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.

    12:20 Closing remarks

    12:30 End of workshop

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    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.
     

    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:

    ‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

    CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

    Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

    CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

    CPD AND PROFESSIONAL INSTITUTES

    There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

    For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

    CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

    TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

    Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

    ‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

    ‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

    The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

    As a formal provider of CPD certified activities, SMI Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

    GLOBAL CPD

    Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

    CPD Certificates

    We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk

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