Course Description:
This one and a half day course will provide valuable assistance to companies that need to design and implement cleaning disinfection programs in regulated environments.
Contamination occurs in every Cleanroom. Incidents can result in increased Cost of Goods (COGS), plant shutdowns and product withdrawn from the market. The goal is to design and implement an effective cleaning and disinfection program to control your Cleanroom environment in order to minimize risk and successfully troubleshoot excursions once they do occur.
The instructors address the latest industry trends, benchmarked against top Pharmaceutical, Biotech, and Medical Device companies, for establishing, maintaining and working in Cleanrooms that will dramatically reduce microbial excursions and facilitate having successful and accurate root cause investigation outcomes. If your job brings you in contact with any aspect of Cleanroom design, maintenance, environmental monitoring, sampling, testing, sanitization, validation, responses to microbial excursions, root cause investigations, or regulatory interactions, you cannot afford to miss this essential training.
Course Objectives:
- Design and implement and effective cleaning and disinfectant program to control the Cleanroom environment to minimize downtime and get the best product yield.
- Provide guidance on industry trends, regulatory feedback, and designs for a successful disinfection validation program which meet FDA and EMA scrutiny. Current 483's, Warning Letters, and Field Experiences will be conveyed that allow end users to determine that best methods to validate their products against their isolates.
- Microbial control in Oral Solid Dose manufacturing.
- Learn how to develop a successful contamination control program with an emphasis on personnel practices, environmental controls, minimizing risks and avoiding common mistakes.
- Learn how to troubleshoot excursions in Pharmaceutical and Biotech Operations.
- Learn how to start-up a new Cleanroon and re-establish control of a Cleanroom after a shut-downs or worse case events.
Who will Benefit:
This course benefits anyone who works in a regulated environment and needs to establish and validate their cleaning and disinfection programs, including companies in the Pharmaceutical, Biotech, and Medical Device fields. The employees who will benefit include:
- QA and QC Managers
- Disinfectant Validation Managers
- Operations Managers
- Cleanroom Managers
- Personnel and contractors that clean and disinfect cleanrooms
- Regulatory Compliance Managers & Environmental Monitoring Managers
- Lean Managers
COURSE OUTLINE:
Training Session I: Gaining and Re-Establishing the Control of the Cleanroom
Training Session II: Microbial Control in Oral Solid Dose Manufacturing
Training Session III: Designing and Implementing and Effective Cleaning and Disinfection Program
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Training Session IV: Contamination Control 101
Training Session V: Advanced Troubleshooting Excursions in Pharmaceutical and Biotech Operations
Training Session VI: Solutions for Addressing Fungal and Bacterial Spore Contamination in Pharmaceutical and Biotech Operations
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Proposed Agenda with Timing:
Day 1 |
Day 2 |
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Meet Your Instructors
Jim Polarine Technical service manager, STERIS Corporation Mr. Polarine is a technical service manager at STERIS Corporation. He has been with STERIS Corporation for over eleven years, where his current technical focus is microbial control in cleanrooms and other critical environments. He has lectured in North America, Europe, Asia, Latin America, and Puerto Rico on issues related to cleaning and disinfection in cleanrooms. Mr. Polarine is a frequent industry speaker and has worked on several books and article publications related to cleaning and disinfection and contamination control. He is currently co-authoring several articles and is a co-author on the PDA technical report on cleaning and disinfection. He is also currently active on the PDA task force on cleaning and disinfection. He is part of the faculty at the University of Tennessee Parenteral Medication course. He has presented at key industry events for PDA, ISPE, AALAS, IVT, University of Tennessee, SWE, and Barnett International on cleaning and disinfection and contamination control. Mr. Polarine also frequently presents global industry webinars on Cleaning and Disinfection for several industry seminar circuits including Compliance Online 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, ISPE, IEST, ASM, AALAS, ASTM, AAAS, AOAC, and ACS. He previously worked as a clinical research coordinator with the Department of Veteran’s Affairs 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. |
Beth Kroeger Technical Services Specialist, STERIS Corporation Beth Kroeger, is a Technical Services Specialist for the Life Sciences Division of STERIS Corporation. She currently provides global technical support related to process research cleaners and critical environments. Beth has over 20 years industry experience in solid-dose pharmaceutical operations and biopharmaceutical manufacturing operations including large scale fermentation systems, both perfusion and fed batch, downstream operations including large scale purification processing, viral removal, UF and final fill. Beth has held positions as an operations manager and as the manufacturing lead on a cross-functional team responsible for the scale-up and technical transfer of 4 biopharmaceuticals. She earned a B.S. in Biological Sciences from the University of Missouri, St. Louis. |
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ComplianceOnline (MetricStream, Inc),
6201 America Center Drive Suite 240
San Jose, CA 95002
USA
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Your Registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ [email protected]
Payment:
Payment is required before 2 days of the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. ( our parent company)
Cancellations and Substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $150 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event.
On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($150) will be transferred to any future ComplianceOnline event and a credit note will be issued.
Substitutions may be made at any time. No-shows will be charged the full amount.
We discourage onsite registrations, however if you wish to register onsite payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available we will send the material after the conference is over.
In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.
Attendance confirmation and Documents to carry to the seminar venue:
After we receive the payment from the registered attendee an electronic event pass will be sent to the email address associated with the registrant before 5 working days from the seminar date. Please bring the pass to the venue of the event.
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Venue
Location :Tampa Airport Marriott
Tampa International Airport
4200 George J. Bean Parkway
Tampa, Florida 33607 USA
November 8 – 9, 2012
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How to Reach
Area Airports
- Tampa International Airport - TPA
- St Petersburg-Clearwater International Airport - PIE
- Orlando International Airport - MCO
Hotel direction: 0.1 mile(s) N
Driving directions:
Hotel is connected to airport terminal on the third level. Guests can walk directly from terminal into hotel lobby. If renting a car, follow the red terminal signs past Airport Parking, we are on the left after the control tower, the Hotel has a parking garage.
Hotel direction: 18 mile(s) E
Driving directions:
Take I- 275 North to Tampa Intl Airport (exit 39B). Follow the Red signs and the Airport Hotel signs.
Hotel direction: 92 mile(s) NE
Driving directions:
Take I-4 West to I-275 South to Exit 39 (Tampa Airport). Follow the Red signs and the Airport Hotel signs.
Bus Station
Greyhound 7 mile(s) E
Train Station
Amtrak 15 mile(s)
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Local Attraction
Museum of Science & Industry (MOSI)
More than 450 activities await you at this non-profit facility dedicated to promoting a better understanding of science and technology. The Saunders Planetarium shows you the stars. Step inside the Gulf Coast Hurricane exhibit for a blast of tropical nightmare. At the IMAX Dome Theatre, the world is bigger than life, filled with odd sights and sounds on a huge screen. Souvenirs ranging from totes and T-shirts to puzzles and posters are available at the Science Store. For refreshment, the MOSI Café offers pizzas, salads and sandwiches. In late February, the BARF (Bay Area Renaissance Festival) takes place here.
Salvador Dali Museum
Housing the largest collection of Salvador Dali works in the world, the museum offers a regularly changing exhibit of the legendary surrealist artist's melting-watch canvases and a wide variety of his sculpture and fiber objects that are, at the very least, intriguing. One memorable creation toasts the cocktail party; it is a vest covered with full glasses of creme de menthe. Daily tours seek to explain this complex man and his equally complex art. In the museum store you can select a memento of your surreal experience. Do check the website or call for timings.
Tampa Museum of Art
Established in 1979, this museum houses more than 4,500 objects in its permanent collection and exhibits the largest collection of Greek and Roman antiquities in the Southeast. The Center Gallery displays themed exhibitions from the permanent collection. For a look at 19th and 20th century sculpture set against the backdrop of the Hillsborough River, visit the Terrace Gallery. Stroll through the Outdoor Courtyard featuring contemporary sculptures, fountains and bronze work. For gifts, books, children's items or home accessories, stop by the museum store.
Craftsman House
Craftsman House is a gallery that showcases contemporary art works. The lush green lawns and beautiful garden welcome visitors in to this creative space. Owned and managed by Stephanie Schorr, it is a gallery-cum-working studio. Here, you will see umpteen art works displayed; jewelry, glass designs and much more work of local and national artists make for its splendid collection. It also has an on-site café serving delicious short eats and variety of beverages including beer and wines. Apart from the art works, Craftsman House also has a pottery studio that features colorful mugs, pots, vases and other wares that will adorn your living room. The innovative designs and art pieces are truly worth a look; so go ahead and visit the Craftsman House soon.
Adventure Island
Located right across the street from Busch Gardens Tampa Bay, Adventure Island’s 30 acres of water-drenched fun in the sun features the ultimate combination of high-speed thrills and tropical, tranquil surroundings for guests of all ages. Within a soothing Key West atmosphere await slides, corkscrews, water falls, a wave pool, children’s water playground and other family attractions.
Busch Gardens
At Busch Gardens, animals roam free and you are the outsider. You can see the park by monorail, cable car or train. Roller coasters, wild animals, entertaining shows, rides, food, shopping, sightseeing, bird shows, exotic flowers, train rides, Serengeti adventures, river rapids...the list goes merrily on. Wear comfy walking shoes and spend the day at this 300-acre park. You can even taste the Anheuser Busch brew that started it all. Busch Gardens is open year-round with varying schedules. Call or see Web site for details.
Florida Aquarium (The)
The Florida Aquarium gives visitors an all-access pass to the mysteries of the deep. Observe seahorses, lobsters, colorful fish, moray eels, gators, river otters, Australian sea dragons and many more. If you're feeling truly adventurous, take advantage of the "Swim with the Fishes" or "Dive with the Sharks" programs (advance reservations required). Kids will love the wide range of colorful and fun-filled interactive displays. The aquarium also sponsors ecotours aboard a 64-foot catamaran, affording patrons an opportunity to get even more up-close-and-personal with the sea. See website for complete list of attractions, calendar of events and more.
John's Pass Village
This scenic village with its nautical heritage and waterfront location offers an assortment of shops, boutiques, restaurants, water sports and entertainment. Located near the sands of Madeira Beach, John's Pass Village is renowned throughout the Bay Area as a site of good crafts and artisans, as well as casually comfortable seafood eateries. Weekends, the Village puts its best fin forward with street shows that include plenty of musical entertainment. From its boardwalk and marina, you can enjoy a free dolphin watch or take off aboard small cruise ships and fishing charters.
Lowry Park Zoo
Tampa's first zoo can trace its history back to the 1930s. In 1957, this collection of animals and birds was moved to its current location. Recognized as the "Number One Family-Friendly Zoo in the U.S." by Child magazine, Lowry Park Zoo features 2,000 animals on 56 acres of lush, natural habitats comprising seven main exhibit areas: Asian Gardens, Primate World, Free-Flight Aviaries, Florida Boardwalk, Florida Manatee and Aquatic Center, Wallaroo Station children's zoo, and Safari Africa. Gift shops, refreshment stands and cafes are located throughout the park.
Moccasin Lake Nature Park
If you've wondered how sun and wind supply power and water and how a host of other things work, this is the spot to find out. This environmental and educational center located at a 50-acre park is highly recommended not only for its low price, but also for its fine educational offerings. You can see a lake, upland forest and wetlands environment here and spot most of the plant and animal species native to this area. A mile-long nature trail winds through the park and an Interpretative Center features wildlife exhibits, displays, information, a classroom and a laboratory.