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PDA 557 Isolator Technology

Nov 17 - Nov 18, 2021
Bethesda, MD

  • Education
  • The Americas
Closed

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.

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.

Please note that this training course has hands-on lab activities.

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

PDA Aseptic Processing Training Courses

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Agenda

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

Trainers

Claire F. Briglia
Claire F. Briglia
Vedere Solutions
Bio
Claire F. Briglia
Vedere Solutions

Claire Fritz Briglia, B.S., has over 20 years of experience in industrial microbiology. She began her career as an R&D scientist at American Sterilizer Company (now STERIS Corporation) developing low temperature decontamination and sterilization systems for both healthcare and life science. She then moved into the field as a specialist for vapor phase hydrogen peroxide decontamination and sterilization applications. In 2010, she transitioned into a specialist role at MilliporeSigma supporting microbial testing and monitoring and started her own consulting company in 2019. She has presented at many industry conferences as well as conducted over a hundred end user training sessions. Recently she authored two chapters for PDA’s Handbook on Environmental Monitoring as well as articles for PDA Letter in 2014 and 2015. She is a member of the PDA Letter Editorial Committee and is an instructor for PDA’s Aseptic Training Course.
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 Operations

    Roles
    Engineer, Specialist, Supervisor, Scientist

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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 October 3, 2021
Member $2,249
Non-member $2,699
Gov't/Health Auth./Academic* $1,749

Regular Registration
Registration Type Price After October 3, 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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