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PDA 247 Technical Report No. 70: Fundamentals of Cleaning and Disinfection Programs for Aseptic Manufacturing Facilities

Nov 01 - Nov 02, 2021
Bethesda, MD

  • Education
  • The Americas
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Overview

Please note that this training course will take place in person and has hands-on lab activities. Long pants and closed-toe shoes are required. Please read our COVID-19 Facility Access Rules before registering for this training course.

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.

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

PDA Cleaning Training Courses

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Agenda

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

Trainers

Brent Watkins
Brent Watkins
Veltek Associates, Inc.
Bio
Brent Watkins
Veltek Associates, Inc.

Brent Watkins is currently the South East Technical Manager for Veltek Associates, Inc., providing contamination control products and services to the pharmaceutical and biotech industries. Prior to Veltek, Brent worked for Abbott Laboratories in small volume injectable operations in a variety of supervisory roles. In addition to his responsibilities at Veltek, he is a course instructor for aseptic processing related topics at the Parenteral Drug Association, was a member of the PDA task force for Technical Report 70 (Fundamentals of Cleaning and Disinfection), and currently serves as the Vice Chair of the Education Advisory Board. Brent graduated from Wake Forest University in 1995 with a Bachelor’s degree in Chemistry and lives near Rocky Mount, NC with his wife, Rebecca, and son, Jacob.

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
    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 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 September 17, 2021
Member $2,249
Non-member $2,699
Gov't/Health Auth./Academic* $1,749
Regular Registration
Registration Type Price After September 17, 2021
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.

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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