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PDA 247 Fundamentals of Contamination Control, Cleaning and Disinfection Programs for Aseptic Manufacturing Facilities

Jun 05 - Jun 06, 2023
Bethesda, MD

  • Education
  • The Americas
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Overview

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

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 (TR70): Fundamentals of Cleaning and Disinfection Programs for Aseptic Manufacturing Facilities.

The training course will cover 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.

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

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Agenda

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  • Training courses generally run from 8:30 to 16:00 each day unless noted on the agenda. Breakfast will not be provided, but lunch will be provided.

Trainers

Arthur Vellutato
Arthur Vellutato
Veltek Associates, Inc.
Bio
Arthur Vellutato
Veltek Associates, Inc.

Art Vellutato, Jr., is the President and CEO of Veltek Associates, Inc. (VAI is an EPA, FDA, and ISO 9001 registered facility) founded in 1981. He is also the President and Senior Consultant of Aseptic Processing, Inc., the consulting division of Veltek Associates, Inc. He is a frequent industry speaker with over 75 industry publications and is one of the leading consultants in the pharmaceutical and biotechnology industry specializing in contamination control, cleaning, disinfection, gowning and environmental monitoring. He lends over 30 years of experience that include his tenure as the V.P of Quality Assurance, the V.P of Validation, and the V.P of Manufacturing at VAI. Art Vellutato, Jr., has conducted training on Cleaning/Disinfection/Contamination Control/EM to the FDA (CDER and CBER) routinely from 2002-2017. He also conducted training for the EMEA in 2004-2012, the Kazakhstan (Russian) Regulatory Agency in 2005 and 2008, and the TGA in 2009 and 2012. Art Vellutato has trained 624,012 industry professionals to date.

Art Vellutato, Jr., is a faculty member at the Parenteral Drug Association’s Training and Research Institute (PDA TRI) for the Aseptic Processing Course (Cleaning and Disinfection Segment), the Coordinator and Faculty Trainer of the PDA TRI Cleaning and Disinfection Course, the Coordinator and Faculty Trainer of the PDA TRI Contamination Control Course, the Chairman of the PDA Cleaning and Disinfection Special Interest Group and PDA Task Force, the Chairman and Technical Writer for the PDA Task Force on Cleaning and Disinfection (TR70), and the Past President of the Delaware Valley Chapter of the PDA (after 15 years). He was named the James P. Agalloco Award – PDA Excellence in Training in 2011, and the 2017 PDA Gordon Personas Award. Art Vellutato, Jr., is also a Faculty Member United States Pharmacopeia (USP) for USP <797> Workshops and a Faculty Trainer for the Aseptic Processing course at Aseptic Training Institute – Clayton, NC.

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

    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
    Quality Control (Microbiology), Manufacturing, Quality Assurance Operations

    Roles
    Analyst, Specialist, Operator/Technician, Supervisor, Manager

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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.

PDA Training and Research Institute

4350 East West Highway, Suite 110
Bethesda, MD

How to Get Here

By Air

The following airports are near the training course location: 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 take your car with you once the training course has ended. After 18:00 hours, you will not be able to access the building or parking garage from the outside.

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.

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Registration Fees

Early Registration
Registration Type Price By April 21, 2023
Member $2,249
Non-member $2,699
Gov't/Health Auth./Academic $1,749
Regular Registration
Registration Type Price After April 21, 2023
Member $2,499
Non-member $2,999
Gov't/Health Auth./Academic $1,749

* 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.

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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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