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

Seoul, Korea
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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 [email protected].

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.

More information coming soon.

GROUP REGISTRATION DISCOUNT: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

Day 1

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

Agenda is subject to change.

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

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.