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Parenteral Drug Association Connecting People, Science and Regulation ®

Isolator Technology

Jun 06 - Jun 07, 2017 |
Jun 07, 2017 |
| Bethesda, MD
  • Education
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Duration: 2 days
Time: 8:30 a.m. - 4:00 p.m.

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 course will provide valuable and practical insights into the design, installation and operation of barrier technology, specifically isolators.

Topics to be addressed include:

  • Evaluating various barrier systems
  • Isolator design
  • Operational requirements
  • Cleaning and decontamination methods
  • Validation of isolators

Who Should Attend

This course is intended for operational personnel who design, carry out and evaluate aseptic operations. Typical areas and roles include the following:

  • Manufacturing: Manager
  • Engineering: Design Engineer
  • Validation: Manager
  • Quality Control: Micro Analyst, Scientist
  • Quality Assurance: Manager

Upon completion of this course, you will be able to:

  • Evaluate whether an isolator is appropriate for your company and meets user requirements
  • Design and discuss methods of cleaning and decontamination that are compatible with the isolator, installed equipment and processes
  • 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
  • Apply the lessons learned to the design, set-up and operations of isolators at your facility

Standard

Member

On or before April 24, 2017
$2,419

After April 24, 2017
$2,699

Nonmember

On or before April 24, 2017
$2,915

After April 24, 2017
$3,239

Government/Health Authority/Academic

$1,619

All rates in US Dollars. REFUND FOR COURSES: If your written request is received by May 8, 2017, you will receive a full refund less a $200 processing fee. After that time, no refunds will be approved. COURSE CANCELLATION: PDA reserves the right to modify the material or instructors without notice, or to cancel an event. If an event must be cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancellation. For more details, contact PDA at info@pda.org or +1 (301) 656-5900.

Class Schedule

All lab courses begin at 8:30 a.m. and end at 4:00 p.m. unless otherwise noted on the confirmation letter or in course information posted on the website or in the course brochures. Courses that are listed with a half day will begin at 8:30 a.m. and end at noon on the last day.

Please arrive at your course location approximately thirty minutes before the start of the course to sign in. Please be sure to bring your confirmation letter as proof of registration. PDA will not allow persons to attend a course without payment or guarantee of payment.

A continental breakfast will be served before class beginning 8:00 a.m. Lunch will be provided from 12:00 - 1:00 p.m. Snacks will be provided during the morning break from 10:00 - 10:15 a.m. and the afternoon break from 2:30 - 2:45 p.m.

Location

The course will be held at:

PDA Training and Research Institute
Bethesda Towers
4350 East West Highway, Suite 150
Bethesda, MD 20814 USA

Recommended Hotel

Hilton Garden Inn Bethesda
7301 Waverly Street | Bethesda, MD 20814 | 0.3 miles from PDA
(301) 654-8111

Contact

For more information, please contact:

Kimberly McIntire
Assistant Manager, Laboratory Operations
Tel: +1 (301) 656-5900 x103
Email: mcintire@pda.org

Christopher Smalley, Director, Engineering, Merck & Co, Inc.

Chris Smalley has spent 5 years at Merck, where he has responsibility for innovative processes implementation and validation, including Single Use Systems, worldwide in the vaccine, pharmaceutical and biotechnology businesses of the organization. Previously, he had been Director of Quality Operations for Wyeth Pharmaceuticals for 12 years with responsibility for setting validation standards and conducting validation activities globally in the pharmaceutical, biotechnology, consumer health and nutritional businesses. 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 the Plant Manager for the Parenterals facility for Janssen Pharmaceutica. Chris retired from the United States Air Force as a LtCol where he practiced as a pharmacist and healthcare administrator, and 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 and a Masters of Science in Pharmaceutical Chemistry from Temple University School of Pharmacy. Chris is a former member of the PDA Board of Directors and the Science Advisory Board.


Donald Eddington, PhD, Technical Consultant, 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.

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 #557 | ACPE #0116-0000-16-021-L04-P | 1.2 CEUs
Type of Activity: Application

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 (PDHs) 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 PDHs.

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