2018 PDA Designing A Risk-Based Cleaning and Disinfection Program for Pharmaceutical, Biotech, and Medical Device Facilities Training Course - Taiwan

Taipei, Taiwan
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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. 

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.

Day 1

8 November 2018

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 a small area of the floor.

10:30 | 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 p.m.
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 and Discussion
Agenda is subject to change.

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  • Jim Polarine Jr., MA, Senior Technical Service Manager, STERIS Corporation
  • Richard Chai, Technical Service Manager, STERIS Corporation