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Parenteral Drug Association Connecting People, Science and Regulation ®

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

Nov 08 - Nov 08, 2018 |
Nov 08, 2018 |
Regent Taipei | Taipei, Taiwan
  • Education
  • 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. 

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.

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






Government/Health Authority/Academic





Student Member





Young Professional Member



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 October 19, 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 or +1 (301) 656-5900.


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


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