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A practical guide to “Risk Based Environmental Monitoring” that addresses real world risk of contamination control.
June 6, 2018
A practical guide to “Risk Based Environmental Monitoring” that addresses real world risk of contamination control.

Learn how to apply the updated ISO Cleanroom Standards and comply with EU Guidance as well as assess product risk through effective cleanroom monitoring. Additionally, learn about choice of monitoring equipment (specification etc.) and establishing risked based sample locations.

Workshop LEADER

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Morgan Polen

Subject Matter Expert on Contamination Control, Microrite

Morgan Polen has been involved with cleanrooms and contamination control since 1984. He has worked in over 40 countries involved with projects ranging from cleanroom design, construction, validation, AFV, monitoring program development, particle counter design and product management for cleanroom related products and systems. He has addressed monitoring and control solutions in a wide variety of clean industries such as pharmaceutical, medical device, semiconductor, data storage, aerospace, defense, automotive, optical and others. Morgan is a member of IEST’s US Technical Advisory Group to ISO/TC 209 Cleanrooms and Associated Controlled Environments, participating in the process of adapting the latest cleanroom standards.

Microrite

Microite is a San Jose, CA based Consulting Company helping Pharmaceuticals, Biotechnology, Medical Devices, In-Vitro Diagnostics and Combination Products in the areas of Quality Assurance, Contamination Control, Microbiology, Process Development, Process Validation, Facility, Utility and Equipement Validation.

Workshop agenda

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8:30

Registration & Coffee

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9:00

Opening Remarks and Introductions

Ziva Abraham, Founder and CEO, Microrite

Morgan Polen, Subject Matter Expert on Contamination Control, Microrite

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9:10

Session 1: Case Study Review: LOearn from the mistakes of Others

  • Case Study: Poorly design Aseptic Filling Line and Monitoring Program leading to media fill and product failures.
  • Case Study: Poorly chosen Monitoring Equipment and Integration.
  • Case Study: Inadequate Air Flow Visualization Studies leading to incorrect (not risk-based) monitoring locations.
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    9:50

    Session 2: Understanding the changes to cleanroom standards (14644-1,2,3) and current regulatory thinking regarding GMP Annex 1; and discussion on recent 483 observations and waning letters

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    10:30

    Morning Coffee

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    11:00

    Session 3: Key Elements of Risk-Based Monitoring Program

  • Site selection
  • Media selection and management
  • Equipment selection and calibration
  • Frequency of monitoring
  • Analyzing EM data to asses risk
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    11:40

    Session 4: Group Exercise

  • Attendees will select risk based sample sites for a "Virtual Aseptic Filling Line" based upon this course material. Attendees will provide justification for their site selection.
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    12:20

    Closing Remarks and End of Workshop

    VENUE

    Crowne Plaza San Diego - Mission Valley

    2270 Hotel Circle North, San Diego, CA, USA

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    Crowne Plaza San Diego - Mission Valley

    2270 Hotel Circle North
    San Diego 92108
    USA

    Crowne Plaza San Diego - Mission Valley

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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.

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    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, SAE Media 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

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