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Isolator Technology - Option 2

Nov 07 - Nov 08, 2019
Bethesda, MD

  • Education
  • The Americas
Closed

Overview

For new and renovated aseptic processing facilities, barrier technologies such as isolators and restricted access barrier systems (RABS) represent systems of choice for optimizing product integrity and as such are being used increasingly for aseptic filling.

This interactive training course will provide valuable and practical insights into the design, installation and operation of barrier technology, specifically isolators. Attendees will learn about isolator design, operational requirements, cleaning and decontamination methods, and validation of isolators.

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Agenda

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  • Training courses run from 8:30 to 16:00 each day, unless otherwise noted.

Trainers

Donald Eddington
Donald Eddington
Eddington and Bond Associates
Bio
Donald Eddington
Eddington and Bond Associates

Donald Eddington, PhD, is a Technical Consultant with Eddington and Bond Associates is a Technical Consultant with Eddington and Bond Associates. His prior employment was with METALL+PLASTIC (M+P) as director of R&D, where he focused on isolators, aseptic processing and hydrogen peroxide decontamination. Prior to M+P, he held various positions at STERIS/AMSCO starting in 1991 as a senior engineer and rising to director of process engineering. His responsibilities included the development and application of hydrogen peroxide sterilization machinery. Eddington received his BS and ME from the University of Florida and his PhD degree from North Carolina State University.
Christopher J. Smalley
Christopher J. Smalley
ValSource Inc.
Bio
Christopher J. Smalley
ValSource Inc.

Chris Smalley has retired from Merck, where he had responsibility for innovative implementation and validation, including Single Use Systems and Isolators globally. He now is a consultant for Valsource, focused primarily on Compounding Pharmacies. Previously, he had been Director of Quality Operations for Wyeth Pharmaceuticals for 12 years with responsibility for setting validation standards and validation activities globally. His research experience includes responsibility for Quality in the U.S. operations of the Sanofi Research Division, and earlier he had worked for the Johnson & Johnson family of companies, where he was a Plant Manager.

Chris retired after 21 years of service as a LtCol in the USAF. Chris practiced as a compounding pharmacist across the military hospital system, compounding intravenous solutions and total parenteral nutrition products. Chris is a graduate of the Philadelphia College of Pharmacy. His graduate education includes a MBA from TU Fox School of Business, a Masters of Science in Pharmaceutical Chemistry from TU School of Pharmacy, and a PhD in Healthcare Administration from LaSalle University.

Chris has been a member of the PDA Board of Directors, the PDA Science Advisory Board, and is a member of the ISPE Disposables CoP Steering Committee and the Pharmaceutical Engineering Committee.

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Evaluate whether an isolator is appropriate for your company and meets user requirements
    2. Design and discuss methods of cleaning and decontamination that are compatible with the isolator, installed equipment and processes
    3. Explain the ergonomic issues that need to be considered in isolator design and placement in order to minimize the number and impact of interventions into the isolator
    4. Apply the lessons learned to the design, set-up and operations of isolators at your facility
  • Who Should Attend

    This training course is intended for professionals who are responsible for the design, installation and operation of isolators.

    Departments
    Manufacturing, Engineering, Validation, Quality Control, Quality Assurance

    Roles
    Engineer, Specialist, Supervisor, Scientist

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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 September 23, 2019
Member $2,519
Non-member $3,023
Gov't/Health Auth./Academic* $1,679





Regular Registration
Registration Type Price After September 23, 2019
Member $2,799
Non-member $3,359
Gov't/Health Auth./Academic* $1,679





* 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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