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This session will discuss pathways to use the data obtained from environmental monitoring to provide proactive and practical solutions for comprehending and managing everyday pharmaceutical microbiology challenges. This presentation will cover case studies on human fl ora and spore contamination in cleanroom 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. 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. The concepts of cleaning and disinfection, application frequency, disinfectant rotation, and rinsing and residue removal strategies will be covered as well.

 

This industry workshop will give attendees valuable insight into the world of contamination control and troubleshooting fungal
and bacterial spore excursions in cleanrooms. Attendees will gain new insight into common causes of CAPA investigations
which will cut down on time that is invested finding potential causes for contamination which can cost an organization 50K per investigation.

 

 

This workshop should be attended by quality managers, validation managers, production managers, operations managers, regulatory managers, and consultants in the pharmaceutical, biotech, and medical device industries.

Workshop LEADER

keynote-img

Jim Polarine

Technical Service Manager, STERIS Corporation

Mr. Polarine is a senior technical service manager at STERIS Corporation. He has been with STERIS Corporation for sixteen years. His current technical
focus is microbial control in cleanrooms and other critical environments. He is active as co-chair on the PDA’s microbial investigations task force. He was a co-author on
PDA’s Technical Report #70 on Cleaning and Disinfection. He is a member of the PDA’s Environmental Monitoring Group, Contamination Control Group, and Biotech Interest Group.

STERIS Corporation

 

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 programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

9:15 Introduction


• Conventional methods
• Limitations

Jim Polarine

Jim Polarine, Technical Service Manager, STERIS Corporation
View Bio

Andrew Bartko

Andrew Bartko, Research Leader, Battelle Memorial Institute
View Bio

9:40 Sensing fundamentals

• Absorption and fl uorescence
• Vibrational and Raman spectroscopy
• Mass spectrometry

Jim Polarine

Jim Polarine, Technical Service Manager, STERIS Corporation
View Bio

Andrew Bartko

Andrew Bartko, Research Leader, Battelle Memorial Institute
View Bio

10:30 Morning Coffee

11:00 Utilisation of spectrometric methods

• Advantages and limitations of new methods
• Comparisons to traditional microbial quality control

Jim Polarine

Jim Polarine, Technical Service Manager, STERIS Corporation
View Bio

Andrew Bartko

Andrew Bartko, Research Leader, Battelle Memorial Institute
View Bio

11:30 Industry case studies

• Vegetative organisms
• Fungal spores
• Bacterial spores

Jim Polarine

Jim Polarine, Technical Service Manager, STERIS Corporation
View Bio

Andrew Bartko

Andrew Bartko, Research Leader, Battelle Memorial Institute
View Bio

12:15 Interactive exercise

Jim Polarine

Jim Polarine, Technical Service Manager, STERIS Corporation
View Bio

Andrew Bartko

Andrew Bartko, Research Leader, Battelle Memorial Institute
View Bio

12:30 End of workshop

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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.

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, 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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