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Isolator Technology - Option 2

Nov 07 - Nov 08, 2019
Bethesda, MD

  • Education
  • The Americas
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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 Smalley
Christopher Smalley
ValSource, LLC
Bio
Christopher Smalley
ValSource, LLC

Chris Smalley has recently retired from Merck, where he had responsibility for innovative implementation and validation, including Single Use Systems 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 is a graduate of the Philadelphia College of Pharmacy of the University of the Sciences in Philadelphia.  His graduate education includes a MBA from Temple University Fox School of Business, a Masters of Science in Pharmaceutical Chemistry from Temple University School of Pharmacy, and a PhD in Healthcare Administration from LaSalle University.

Chris has been a member of the PDA Board of Directors, as well as a member of the PDA Science Advisory Board.  Currently he is a member of the ISPE Disposables CoP.

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

    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

  • 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: 557 / 0116-0000-19-004-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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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 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 Oct 08, 2019, no fee will be charged. After Oct 08, 2019, 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 Oct 08, 2019, a full refund will be given minus a $200 fee. After Oct 08, 2019, 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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Tel: +49 (0) 30 43 655 08-10

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