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One and a Half-day In-person Seminar: Contamination-Control and Cleaning and Disinfection

By:
Jim Polarine,
Technical service manager, STERIS Corporation
Beth Kroeger,
Technical Services Specialist, STERIS Corporation
Coming soon.. Please contact customer care for new schedule

Course Description:

Course "One and a Half-day In-person Seminar: Contamination-Control and Cleaning and Disinfection" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

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 Incidents can result in increased Cost of Goods (COGS), plant shutdowns and product withdrawn from the market.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

  1. Systems for bringing up a new cleanroom
    1. Addressing bioburden and soiling
    2. Checking HEPA filters, temperature, pressure, etc.
    3. Environmental Monitoring and Data Trending
  2. Addressing the cleanroom after shutdown or worst case event
    1. Addressing Bioburden and spoiling
    2. Checking HEPA filters, and other systems
    3. Environmental Monitoring
    4. Getting the Cleanroom up and running
  3. Excursion Events
    1. Triple cleaning and Addressing Bioburden
    2. Environmental Monitoring and Data Trending
    3. CAPA for future excursion events

Training Session II: Microbial Control in Oral Solid Dose Manufacturing
  1. Equipment and equipment parameters
    1. Rouge and pitting
    2. Microbes and contamination issues
  2. Longer term solutions to equipment contamination
    1. Being proactive
    2. Selecting the best solutions
  3. Room Decontamination and Control
    1. Case Studies
    2. The best products and solutions for control

Training Session III: Designing and Implementing and Effective Cleaning and Disinfection Program
  1. Global regulations on germicides
    1. EPA
    2. Europe
    3. Asia Pacific
  2. Disinfection Technologies Globally
  3. Safety Using Disinfectants
    1. Toxicity Discussion
    2. Use Dilution vs. Concentrated products
  4. Application Methods
    1. Application equipment
    2. Alternative methods of application
    3. Best practices in application
   

Training Session IV: Contamination Control 101

  1. Microbial control objectives
  2. Environmental Controls
  3. Personnel Practices
  4. Cleaning and Disinfection
  5. Deleterious Exposure Effects
  6. Minimizing Problems
  7. Troubleshooting Excursions

Training Session V: Advanced Troubleshooting Excursions in Pharmaceutical and Biotech Operations
  1. Causes and Sources of Environmental Excursions
  2. Contamination Control Strategies
  3. Facilities design flaws
  4. Traffic control and personnel practices
  5. Cleaning and disinfection program improvements
  6. Best practices on bringing items into cleanrooms
  7. Common issues that can be changes to avoid excursions
  8. Basics on environmental monitoring
  9. Interactive Group Exercises

Training Session VI: Solutions for Addressing Fungal and Bacterial Spore Contamination in Pharmaceutical and Biotech Operations
  1. How to Ensure Your Cleaning and Disinfection Program is Robust
    1. Learn disinfectant regulations
      1. Manufacturer’s regulations
      2. Pharmaceutical and Biotech regulations
    2. Review “real world” examples of cleaning and disinfection programs
    3. Increase awareness of elements that make cleaning and disinfection successful
  2. Troubleshooting Problems Related to Cleaning and Disinfection
    1. Problems associated with contact time
    2. Problems associated with dilution rates
    3. Problems associated with application
    4. Problems associated with corrosion or the porosity of substrates
  3. Safety Related to Application and Application Techniques of Disinfectants
    1. Safety of the concentrated disinfectant vs. the use dilution
    2. Application of disinfectant products in cleanrooms and controlled areas
    3. Frequency of application will be addressed


Proposed Agenda with Timing:

Day 1

 

Day 2

08:30-08:45AM Introduction
08:45-10:15AM Designing and Implementing and Effective Cleaning and Disinfection Program (JP)
10:15-10:45AM Business Break
10:45-12 Noon Advanced Troubleshooting Excursions in Pharmaceutical and Biotech Operations (BK)
12 Noon-1:00PM Lunch
01:00-02:30PM Solutions for Addressing Fungal and Bacterial Spore Contamination in Pharmaceutical and Biotech Operations (JP)
02:30-02:45PM Q&A
02:45-03:15PM Business Break
03:15-04:30PM Microbial Control in Oral Solid Dose Manufacturing (BK)
   
08:30-9:00AM Introduction and Q&A
09:00-10:15AM Contamination Control 101 (BK)
10:15-10:30AM Business Break
10:30-11:30AM Gaining and Re-Establishing the Control of the Cleanroom (JP)



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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Location :


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How to Reach

Area Airports

  • Tampa International Airport - TPA
  • 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.

  • St Petersburg-Clearwater International Airport - PIE
  • 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.

  • Orlando International Airport - MCO
  • 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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What past attendees say about ComplianceOnline Seminars:

The event was really well organized and ComplianceOnline staff helped make it a smooth process from initial registration, hotel bookings and seminar materials and stationery. I will be asking my company to send more employees to attend ComplianceOnline seminars.
- Legal Advisor

I've attended quite a few seminars by different training providers but ComplianceOnline was by and far the best - the courses are well designed and up to date with the latest developments and the support staff are always helpful, ready to answer your queries.
- Chief Finance Officer

My company has been sending employees to attend ComplianceOnline seminars and so far we have not been disappointed by the quality of the teaching and the excellent event coordination and support.
- Risk Manager

The best part of the seminar had to be the interactive workshop exercises - the real world scenarios helped me understand the process so much better.
- Chief Security Officer

I attended the ComplianceOnline seminar on the recommendation of a colleague and I found it exactly as helpful as he'd described. I am sure the knowledge I've gained will help me and my company immeasurably.
- Managers of outsourcing service

The ComplianceOnline seminar instructor had deep knowledge of the subject and helped all the attendees understand the subject.
- IT, QA Manager

The instructor was not only active and helpful during the seminar and workshop, but was available to answer resulting queries after the event as well.
- Vice President

I think ComplianceOnline seminars are value for money - the instructors are well prepared and ready to go beyond and above the call of duty to answer even the most complicated of queries regarding subject.
- Internal Auditor





Accreditation




The RAPS Regulatory Affairs Certificate Program offers unique curricula to round out your regulatory knowledge and professional skills with a focus on medical devices and/or pharmaceuticals. Whether you are looking to gain a better understanding of the regulated health product industry or bolster your credibility and resume or curriculum vitae, the Regulatory Affairs Certificate Program is a valuable resource in your pursuit of professional advancement.




After completion of course "One and a Half-day In-person Seminar: Contamination-Control and Cleaning and Disinfection" RAPS certificate will be issued to attendee.





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Local Attraction

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.




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.




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 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.




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.




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.




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.




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.




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.




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.





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