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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.
 

The current regulatory thinking related to risk-based monitoring and utilizing smoke study data for identifying these sample locations indicates that regulators are aware of the prevalence of data integrity in environmental monitoring. The scrutiny regulators place on smoke studies is evident in 483 observations as well as warning letters.

Learn about the various aspects of pragmatic and scientific risked-based environmental monitoring that identifies real world risk and weaknesses in system design.
• Pragmatic risk assessment is science based not an exercise
• Understanding Real-world risks verse perceived risks
• Common Cleanroom/barrier system design flaws that lead to data integrity situations
• Air flow visualization, The most misunderstood and under utilized tool for aseptic operations.
• Learn from the mistakes of others, Case studies will be provided.

• Senior Microbiologists
• Lead Scientists
• Laboratory Managers
• QA Specialists
• Drug Substance External Manufacturers
• QC Scientists
• Heads of Quality
• Business Development Managers
• Pharmaceutical Microbiology Consultants
• Higher Pharmacopoeial Scientists
• Analytical Standards Specialists
 

Workshop programme

13:30 Registration & Coffee

14:00 Opening remarks and introductions

Ziva Abraham

Ziva Abraham, CEO, Microrite, Inc.

Morgan  Polen

Morgan Polen, Contamination Control Expert, Microrite, Inc.

14:10 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

Ziva Abraham, CEO, Microrite, Inc.

Morgan  Polen

Morgan Polen, Contamination Control Expert, Microrite, Inc.

14:50 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

Ziva Abraham, CEO, Microrite, Inc.

Morgan  Polen

Morgan Polen, Contamination Control Expert, Microrite, Inc.

15:30 Afternoon Tea

16:00 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

Ziva Abraham, CEO, Microrite, Inc.

Morgan  Polen

Morgan Polen, Contamination Control Expert, Microrite, Inc.

16:40 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

Ziva Abraham, CEO, Microrite, Inc.

Morgan  Polen

Morgan Polen, Contamination Control Expert, Microrite, Inc.

17:20 Closing Remarks and End of Workshop

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VENUE

Hyatt Regency Mission Bay

1441 Quivira Road, San Diego, California, USA

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.

A number of our clients have been approached by third party organisations offering to book hotel rooms. We would advise that you do not book through them as they are not representing the SMi Group. SMi Group books all hotel rooms directly. If you are approached by a third party organisation then please contact us before making any bookings. If you have already booked a hotel room using a third party organisation, we would highly recommend contacting the hotel you were booked into to ensure a booking has been made for you. We would also advise you to please check the terms and conditions of the booking carefully.
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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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