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PDA Designing a Risk-Based Cleaning and Disinfection Program for Pharmaceutical, Biotech, and Medical Device Facilities Training Course

Apr 19 - Apr 19, 2018 |
Apr 19, 2018 |
Imperial Palace Seoul | Seoul, Korea
  • Education
  • Western Hemisphere Events
  • Asia-Pacific
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Many regulatory inspections fail because of inadequate behavior in the manufacturing environment, with the reason being often too little knowledge of cleaning and disinfection practices. The PDA Designing a Risk-Based Cleaning and Disinfection Program for Pharmaceutical, Biotech, and Medical Device Facilities Training Course will teach what the regulations ask for, how cleaning and disinfections must be performed. The Course gives the theoretical background with practical examples (with equipment) in group exercises. In a step-by step approach, participants learn how to plan, execute cleaning and disinfection, removal of residues, and how to control results. Participants learn from real case studies what needs to be done to have the cleanrooms under control. Questions can be sent in advance to roessling@pda.org.

Who Should Attend

Engineers, scientists, supervisors, managers, and people working in cleanrooms and on the shop floor, individuals dealing with environmental controls, and those responsible for validation activities.

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Thursday, April 19

8:00 – 17:30 | Registration Open

9:00 – 10:15

9:00 | Regulations

  • Selection, methods of cleaning and disinfection, disinfectant rotation, frequency

10:15 – 10:30 | Refreshment Break

10:30 – 12:15

10:30 | Practical 1: Application of Disinfectants

  • Participants will have hands on practice on using 2 buckets and 3 buckets system for cleaning small area of floor.

11:15 | Group Exercise 1

  • Participants to design a cleaning and disinfection program for a new facility (Selection, cleaning frequency for ISO 5, 7, and 8 cleanrooms), and calculation of disinfectant change out frequency.

12:15 – 13:00 | Networking Luncheon

13:00 – 15:15

13:00 | Residue Removal and Rinsing Strategies and Bringing Cleanroom Online After a Worst-Case Event

13:45 | Practical 2: Residue Removal

  • Participants to use IPA or water to remove residues from substrates.

14:30 | Group Exercise 2

  • Participants to design a cleaning procedure to bring cleanroom back online.

15:15 – 15:30  | Refreshment Break

15:30 – 17:30

15:30 | Overview of Disinfectant Validation and Microbial Contamination Control

16:30 | Group Exercise 3

  • A contamination scenario is given to participants.
  • Participants to use fishbone diagram to perform microbial contamination investigation in cleanroom.

17:15 | Q&A

Standard

Member

$495

Nonmember

$675

Government/Health Authority/Academic

Member

$315

Nonmember*

$315

Student Member

Member

$200

Nonmember*

$250

Young Professional Member †

Member

$270

All rates in US Dollars.

*For this member type or discounted rate, online registration is not available and must be faxed in.

† You must be a member to take advantage of this rate.

REFUND FOR COURSES: If your written request is received by March 30, 2018, you will receive a full refund less a $200 processing fee. After that time, no refunds will be approved. COURSE CANCELLATION: PDA reserves the right to modify the material or instructors without notice, or to cancel an event. If an event must be cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancellation. For more details, contact PDA at info@pda.org or +1 (301) 656-5900.

Contact

Molly O'Neill Moir, CMP
Vice President, Programs & Meetings
Tel: (301) 656-5900 ext. 132
Email: moir@pda.org

 

Jim Polarine Jr., MA, Senior Technical Services Manager, STERIS Corporation

Mr. Polarine is a senior technical service manager at STERIS Corporation. He has been with STERIS Corporation for seventeen 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. Mr. Polarine teaches the cleaning and disinfection course at the PDA Aseptic Processing Course and at the University of Tennessee’s Parenteral Medications Course. Mr. Polarine is currently President Elect for the PDA Missouri Valley and Technical Coordinator for IEST. Mr. Polarine graduated from the University of Illinois with a Master of Arts in Biology. 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.

More information coming soon.
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