Home
overview

Staying ahead of the curve with Contamination Control requires an understanding and an anticipation of the constantly changing microbial climate of the pharmaceutical manufacturing process. Knowing the characteristics of the environments in that process provides the benefit of allowing us to predict and solve potential future microbial control issues. 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 workshop will cover case studies on human flora and spore contamination in cleanroom operations. Solutions will be discussed to proactively present future contamination issues.

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 covered. 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 workshop will be to discuss specific cases studies that have occurred in my years of experience in the industry. Specific long term solutions will be conveyed to prevent reoccurrences and yield higher levels of control in the cleanroom operations. The concepts of cleaning and disinfection, application frequency, disinfectant rotation, and rinsing and residue removal strategies will be covered in complete detail as well.

 

Co-hosted by:

Jim Polarine, Senior Technical Service Manager, STERIS Corporation

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, hospital compounding, and medical device industries.

Workshop LEADER

keynote-img

Jim Polarine

Senior 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 has lectured in North America, Europe, Middle East, Asia, and Latin America on issues related to cleaning and disinfection in cleanrooms. Mr. Polarine is a frequent industry speaker and published several PDA book chapters and articles related to cleaning and disinfection and contamination control. 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. He is president-elect with the PDA Missouri Valley Chapter. He is part of the faculty at the University of Tennessee Parenteral Medication course. He is also active with the IEST Special Topics Committee on Cleaning and Disinfection. He has presented at key industry venues for NASA, USP, PDA, ISPE, FDA, SIMB, GBPR, IPA, AALAS, IVT, IEST, University of Tennessee, SWE, STERIS Applied Sterilization Technologies, and Barnett International on cleaning and disinfection, disinfectant validation, and contamination control. Mr. Polarine frequently presents global industry webinars on Cleaning and Disinfection for several industry seminar circuits including Compliance Online, STERIS, and Executive Conferences. Mr. Polarine graduated from the University of Illinois with a Master of Arts in Biology, and is a member of the PDA, SIMB, ISPE, IEST, ASM, ASTM, AAAS, AOAC, and ACS. He previously worked as a clinical research coordinator with the Department of Veterans Affairs in St. Louis, MO and as a biology and microbiology instructor at the University of Illinois. His main hobby is storm chasing and is very active in tornado research and tornado safety.

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.

Workshop programme

13:30 Registration & Coffee

14:00 Opening Remarks

14:10 Session 1 – Common Sources of Contamination: Case Studies

Jim Polarine

Jim Polarine, Senior Technical Service Manager, STERIS Corporation
View Bio

14:50 Session 2 – A Risk Based Cleaning and Disinfection Program

Jim Polarine

Jim Polarine, Senior Technical Service Manager, STERIS Corporation
View Bio

15:30 Afternoon Tea

16:00 Session 3 – Key Elements of a Successful Disinfectant Validation Program

Jim Polarine

Jim Polarine, Senior Technical Service Manager, STERIS Corporation
View Bio

16:40 Session 4 – Bringing the Cleanroom Online After a Worst-Case Event

Jim Polarine

Jim Polarine, Senior Technical Service Manager, STERIS Corporation
View Bio

17:20 Closing Remarks

17:30 Close of Workshop

+

Renaissance Woodbridge Hotel

515 US Highway 1 South
Iselin 08830
USA

Renaissance Woodbridge Hotel

Your simple delights will become memorable moments at Renaissance Woodbridge Hotel. This distinctive hotel in Edison, New Jersey, features 269 modern guest rooms, including 42 suites, and more than 25,000 square feet of flexible meeting space. Our hotel's location is centrally located amidst corporate offices and tourist attraction. Our accommodations stand out from other hotels in Edison, NJ, and provide a sophisticated retreat for families and business travelers alike. Marriott's Plug-in panels and 37-inch LCD HD TVs allow guests simultaneous connectivity to laptops, iPods and DVD players. We are one of the most conveniently situated hotels at the crossroads of U.S. Routes 1 and 9. We are also just five minutes from Woodbridge Center Mall, 15 minutes south of Newark Liberty International Airport (EWR) and less than one mile from the Metropark train station. With our premier location and amenities, our Edison accommodations provide an advantageous travel destination.

HOTEL BOOKING FORM

Title

SubTitle
speaker image

Content


Title


Description

Download


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

Event Title

Headline

Text
Read More

I would like to speak at an event

I would like to attend an event

I would like to sponsor/exhibit at an event

SIGN UP OR LOGIN

Sign up
Forgotten Password?

Contact SMi GROUP LTD

UK Office
Opening Hours: 9.00 - 17.30 (local time)
SMi Group Ltd, 1 Westminster Bridge Road, London, SE1 7XW, United Kingdom
Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
Website: http://www.smi-online.co.uk Email: events@smi-online.co.uk
Registered in England No: 3779287 VAT No: GB 976 2951 71




Forgotten Password

Please enter the email address you registered with. We will email you a new password.