Skip To The Main Content

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

Nov 08, 2018
Taipei, Taiwan

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.

  • Education
  • Asia-Pacific

left to register

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. 

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.

Agenda

  • 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

Additional Information

  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • Who Should Attend

    Who Should Attend

    More information coming soon.

  • Accreditation

    Accreditation

    Continuing Education for Pharmacists

    ACPE PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:

    PDA # / ACPE # / CEUs:
    Type of Activity: Not Applicable

    ALERT   ACPE and NABP developed the CPE Monitor that allows pharmacists to electronically track their continuing pharmacy education (CPE) credits. The CPE Monitor will reject any CPE credit requests submitted past 60 days from date of ACPE-accredited activity. Always submit CPE activity claims as soon as possible. For more information, please visit the ACPE or NABP website.
    Continuing Education for Professional Engineers
    New Jersey

    PDA is an approved provider by the New Jersey State Board of Professional Engineers and Land Surveyors to offer courses to New Jersey Professional Engineers for Continuing Professional Competency (CPC) credit. Following the full participation in this course, participants will receive a Certificate of Accomplishment specifying the number of CPC credits that may be awarded. This certificate can be submitted as verification of completion to the Board for license renewal.

    The credit value of this course is CPC credits.
    North Carolina

    PDA is recognized by the North Carolina Board of Examiners for Engineers and Surveyors as an Approved Sponsor of Continuing Professional Competency (CPC) activities for Professional Engineers licensed by North Carolina. To receive a Certificate of Accomplishment specifying the number of Professional Development Hours (PDH) that may be awarded, course participants must request the North Carolina Board of Examiners evaluation form from PDA staff. This form must be completed onsite at the conclusion of the course and returned to PDA staff.

    The credit value of this course is PDH credits.

Got a Question? We have answers

Contact Us

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.

Regent Taipei


Taipei, Taiwan

How to Get Here

By Air

More information coming soon.

By Car

More information coming soon.

Other Options

More information coming soon.

Directions

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 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 [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 Government/Health Authority/Academic nonmembers, online registration is not available and must be faxed in.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Special Dietary Requirements

If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

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 as soon as possible and will receive a full refund. PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees and exhibitors and may be used to follow up on specific areas of interest after the event. Tape recordings are prohibited at all PDA events. For more information, contact [email protected] or +1 (301) 656-5900.

SUBSTITUTION: If a substitution request is sent 30 days before the event, no fee will be charged. After this period, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent 30 days before the event, a full refund will be given minus a $200 fee. After this period, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to [email protected]. Phone messages are not accepted.

Sponsors

Become a Sponsor

Interested in becoming a sponsor? Learn about opportunities and benefits.

Request Information

Exhibitors

Attendee List Email Scam

Unfortunately, emails are circulating that offer to sell attendee lists for many of PDA’s conferences and events. These emails are sent by scammers.

Note: PDA does not sell its exhibitor or attendee lists, and no third-party is authorized to distribute or sell any lists related to our events. Statements claiming to offer our attendee lists are fraudulent. If you receive emails that propose to sell PDA conference attendee lists, do not engage with the sender and delete the message immediately.

Become an Exhibitor

Interested in becoming an exhibitor? Learn about opportunities and benefits.

Request Information

Media Partners

Related Events

Contact

Program Inquiries
Exhibition Inquiries
Training Course Inquiries

Tel: +1 (301) 656-5900
[email protected]

Tel: +49 (0) 30 43 655 08-10

Registration Customer Care

Tel: +1 (301) 656-5900 ext. 115
[email protected]

PDA Members Save Substantially