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Solutions for addressing fungal and bacterial spore contamination in pharmaceutical and biotech operations
17 January 2017
Solutions for addressing fungal and bacterial spore contamination in pharmaceutical and biotech operations

 The workshop will cover the most common causes of contamination: operators, items brought into the cleanroom, and degradation of the cleanroom over time. Case studies in operator borne contamination will be discussed as well as preventative long term solutions. Specific examples of aerobic and anaerobic vegetative bacteria will be highlighted and analyzed. Items brought into cleanrooms that can harbor fungal and bacterial spores will be discussed as well as specific case studies highlighting examples where sources were items brought into the cleanroom or in some cases other common causes. Fungal and bacterial spore structures as well as efficacy testing and specific test conditions will be briefly discussed. Solutions will be presented to prevent efficacy testing failures due to test method, recovery, and coupon porosity issues. Targeted long term solutions will be discussed regarding the spore case studies in a concerted effort to limit reoccurrences.
The overall objective and scope of this seminar will be to discuss specifi c cases studies that have occurred in my years of experience in the industry. Specific and precision long term solutions will be conveyed to prevent reoccurrences and yield higher levels of control in the cleanroom operations.

Workshop LEADER

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Andrew Bartko

Research Leader, Battelle Memorial Institute

Dr. Andrew P. Bartko received a B.S. from the University of Pittsburgh in 1997 and a Ph.D. in physical chemistry in 2002. Dr. Bartko is a senior scientist in Battelle’s Technology Development Group where he contributes to several applied spectroscopy efforts that focus on biological and chemical sensing. Dr. Bartko is the manager and technical leader of an interdisciplinary team that is developing Battelle’s Resource Effective Bioidentification System (REBS). Dr. Bartko has developed several rapid microbial control applications for industries such as defense, security and industrial market sectors.

Battelle Memorial Institute

 

STERIS is a global leader in infection prevention,
contamination control, surgical and critical care
technologies, and more. STERIS is the world’s pre-eminent
infection prevention, decontamination, and surgical and
critical care company.
Every day, the people of Battelle apply science and
technology to solving what matters most. At major
technology centers and national laboratories around
the world, Battelle conducts research and development,
designs and manufactures products, and delivers critical
services for government and commercial customers.

Workshop agenda

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8:30

Registration & Coffee

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9:00

Contamination control strategies and conducting CAPA investigations

Jim Polarine, Technical Service Manager, STERIS Corporation

Andrew Bartko, Research Leader, Battelle Memorial Institute

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10:00

Case studies in contamination control

Jim Polarine, Technical Service Manager, STERIS Corporation

Andrew Bartko, Research Leader, Battelle Memorial Institute

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11:00

Morning Coffee

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11:30

Solutions to overcome contamination and interactive exercise in contamination control

Jim Polarine, Technical Service Manager, STERIS Corporation

Andrew Bartko, Research Leader, Battelle Memorial Institute

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12:30

End of Workshop

Holiday Inn Kensington Forum

97 Cromwell Road
London SW7 4DN
United Kingdom

Holiday Inn Kensington Forum

Holiday Inn Kensington Forum is perfectly situated in one of London’s most luxurious and beautiful areas within South Kensington. 

The hotel is just 2 minutes walk from Gloucester Road tube station for convenient travel to Hyde Park, London Eye, Tower Bridge plus more of London’s top attractions. There are also easy and direct links to some major transport hubs including Victoria, Kings Cross St Pancras, Paddington and Heathrow. 

This distinctive hotel in south London has so much to offer to make all guests really feel at home. The latest Holiday Inn relaunch is not just about the new look and feel for the hotel but to offer guests more benefits during their stay including a pillow menu for extra comfort during their sleep and a curved shower rail for more spacious feel. 

In addition to our 906 rooms, all business guests can take advantage of our meeting and conference facilities including High Speed Internet Access and unlimited Starbucks coffee at The Academy. Our hotel’s professional event planners are on board to help take the hard work and stress away from planning your next event. 

So whether you in London on business or pleasure, make the Holiday Inn London Kensington Forum your first choice of hotel and book your accommodation for our lowest internet rate guarantee. 

HOTEL BOOKING FORM

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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.

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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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