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

Apr 19, 2018
Seoul, Korea

  • Education
  • The Americas
  • Asia-Pacific
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Overview

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.

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Agenda

  • 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

Additional Information

  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • Who Should Attend

    More information coming soon.

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Travel

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.

Imperial Palace Seoul

640 Eonju-ro, Nonhyeon-dong, Gangnam-gu
Seoul, Korea

How to Get Here

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Registration Fees

Regular Price

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 [email protected] or +1 (301) 656-5900.

Contact

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

 

* For this member type or discount, online registration is not available, please contact [email protected].

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].

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