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Technical Report No. 70: Fundamentals of Cleaning and Disinfection Programs for Aseptic Manufacturing Facilities

May 04 - May 05, 2020
Bethesda, MD

  • Education
  • The Americas

Overview

Controlling contamination in GMP classified areas requires much more than cleaning and disinfection. Operations need to assure that a complete system of control that starts with entry of components and personnel to the facility is established. This training course will identify and describe systematic elements essential to assuring an appropriate and compliant contamination control program for aseptic manufacturing facilities, classified and non-classified environments. This training course will also highlight the important aspects of PDA Technical Report No. 70 (TR 70), Fundamentals of Cleaning and Disinfection Programs for Aseptic Manufacturing Facilities.

The training course covers the critical steps to developing and validating a complete contamination control program within controlled and non-controlled environments using chemical agents that reduce or destroy microorganisms. While sterile product manufacturing requires the most stringent application, the concepts introduced during the training course can also be used to design a program for the manufacture of non-sterile products.

Please note that this training course has hands-on lab activities. Please wear long pants and closed-toe shoes.

For more options and/or related training courses, please visit the page(s) below.

PDA Cleaning Training Course Series

Agenda

  • An agenda will be available soon. Training courses generally run from 8:30 to 16:00 each day. Breakfast will not be provided, but lunch will be provided.

Trainers

Arthur Vellutato
Arthur Vellutato
Veltek Associates, Inc.

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Describe current contamination control principles as they relate to the cleanliness and sterility of product contact and non-product contact surfaces
    2. Analyze current regulations, guidance and industry standards as they relate to contamination control
    3. Generate appropriate cleaning and disinfection procedures for controlled environments
    4. Develop validation protocols for appropriate implementation of cleaning systems and chemical agents
    5. Conduct antimicrobial effectiveness testing and in-situ field studies at your facility
  • Who Should Attend

    Who Should Attend

    This training course is intended for professionals who are responsible for or involved in the cleaning and disinfection program for a sterile drug manufacturing facility.

    Departments
    Manufacturing, Quality Control, Quality Assurance

    Roles
    Technician, Specialist, Analyst, Supervisor, Manager

  • 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: 247 / 0116-0000-16-034-L04-P / 1.2
    Type of Activity: Application

    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 12 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 12 PDH credits.

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Travel

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PDA Training and Research Institute

4350 East West Highway, Suite 110
Bethesda, MD

How to Get Here

By Air

The Washington/Bethesda area is serviced by the following airports: Ronald Reagan National Airport (DCA), Washington Dulles International Airport (IAD), and Baltimore Washington International Thurgood Marshall Airport (BWI).

By Car

There is a parking garage located at the training course location. The fee is $12/day. Please do not leave your car in the parking garage past 6:00 p.m. as both the building and parking garage access doors are locked.

Other Options

Metro – Ride the Red Line of the Metro and depart at Bethesda station. It is a 5-minute walk from Bethesda station to the training course location.

Amtrak – Ride Amtrak and depart at Union Station. From Union Station, ride the Red Line of the Metro and depart at Bethesda station. It is a 5-minute walk from Bethesda station to the training course location.

Directions

Registration Fees

Early Registration
Registration Type Price By March 20, 2020
Member $2,519
Non-member $3,023
Gov't/Health Auth./Academic* $1,959
Regular Registration
Registration Type Price After March 20, 2020
Member $2,799
Non-member $3,359
Gov't/Health Auth./Academic* $1,959

* 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 by Apr 04, 2020, no fee will be charged. After Apr 04, 2020, 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 by Apr 04, 2020, a full refund will be given minus a $200 fee. After Apr 04, 2020, 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.

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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]

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