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Data Integrity in Environmental Monitoring: Causes and Solutions (Virtual Workshop)
June 16, 2021
Data Integrity in Environmental Monitoring: Causes and Solutions (Virtual Workshop)

Data integrity issues related to media fills or environmental monitoring often are symptoms of a larger problem, poor cleanroom / barrier system design, integration or operational practices.

EM and Media fill data integrity often begins with poorly executed Smoke Studies. As poorly designed and implemented cleanroom/barrier systems can not reliably and repeatably meet the viable/non-viable limits established in cGMP. Poor air flow in aseptic manufacturing can create a situation where random EM excursions are blamed on operators and companies are forced to falsify data in order to meet production schedules. Often these design flaws would be identified in a comprehensive static and dynamic smoke study. Instead

Regulatory observations and warning letters related to environmental monitoring are not new; however, observations related to smoke studies, cleanroom/barrier system design flaws are also indicative of an unsuitable environmental monitoring or fraudulent environmental monitoring data.
 

FEATURED SPEAKERS

Morgan  Polen

Morgan Polen

Contamination Control Expert, Microrite, Inc.
Ziva Abraham

Ziva Abraham

CEO, Microrite, Inc.

Morgan Polen

Contamination Control Expert, Microrite, Inc.
Morgan  Polen

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 programme 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.

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 25 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

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9:00

Opening remarks and introductions

Ziva Abraham, CEO, Microrite, Inc.

Morgan Polen, Contamination Control Expert, Microrite, Inc.

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9:10

Session 1

• Understanding the current expectations related to environmental monitoring
• Why facility design issues may result in unsuitable airflows, which can become a cause of data integrity during monitoring to avoid consistent excursions
• Propagated myths about smoke studies that is leading to data integrity by choosing incorrect sites
• Why smoke studies are the best tools to select risk based sites
 

Ziva Abraham, CEO, Microrite, Inc.

Morgan Polen, Contamination Control Expert, Microrite, Inc.

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9:50

Session 2

• Common cleanroom and barrier system design flaws that lead to data integrity in environmental monitoring
• Template based environmental monitoring procedures vs risk based monitoring program
• Understanding the standards and guidance’s related to monitoring
 

Ziva Abraham, CEO, Microrite, Inc.

Morgan Polen, Contamination Control Expert, Microrite, Inc.

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10:30

Morning Break

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10:45

Session 3

• Choice of particle counters-key to accurate qualification and monitoring
• Active air samplers- learn the science to get accurate recovery
• Media issues that can result in slow or no growth
• Reading environmental monitoring plates-mistakes commonly made
 

Ziva Abraham, CEO, Microrite, Inc.

Morgan Polen, Contamination Control Expert, Microrite, Inc.

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11:25

Session 4

• Trending-the key to assessing patient risk
• Why lack of clinical microbiology knowledge fails in assessing patient risk
• Why most CAPAs related to EM excursions are just a paper exercise if science is not applied for the start
 

Ziva Abraham, CEO, Microrite, Inc.

Morgan Polen, Contamination Control Expert, Microrite, Inc.

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12:05

Closing Remarks and End of Workshop


Contamination Control Expert
Microrite, Inc.
CEO
Microrite, Inc.

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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, 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

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@saemediagroup.com

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