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Parenteral Drug Association Connecting People, Science and Regulation ®

Design, Operation, and Qualification of Pharmaceutical Water Systems - NEW

Mar 21 - Mar 23, 2017 |
Mar 23, 2017 |
PDA Training and Research Institute | Bethesda, Maryland
  • Education
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Duration: 3 days
Time: 8:30 a.m. - 4:00 p.m.

There are many common misconceptions regarding the design and operation and pharmaceutical water systems. By recognizing the current, official requirements for design, operation, and monitoring of these systems and using a science and risk based paradigm, a reduction on capital and operating expenses can generally be realized.

This is a classroom-based course in lecture format designed to educate participants on the design, validation, and operation of pharmaceutical water systems for parenteral manufacturing. Content will include a variety of exercises and encourage audience participation and feedback.

The content will include generation methods for Water for Injection (WFI) and other classifications of water, storage and distribution options for waters, and pure steam generation and distribution. Emphasis will be placed on regulatory requirements, the impact of global GMPs on design and operations, and risk-based initiatives for pharmaceutical waters.

The primary objectives of the course are to review new regulations regarding WFI manufacturing, clarify misconceptions regarding the design of these systems, and educate participants on how to adopt a science- and risk-based  design, operation, and monitoring of pharmaceutical water systems.

Who Should Attend

  • Personnel in Quality Assurance and Quality Control
  • Validation Engineers
  • Facilities and Manufacturing Engineers
  • Project Managers
  • Design and Process Engineers

Prerequisites

Working knowledge of GMPs for the pharmaceutical industry and general familiarity with process systems is a plus.

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

  • Define the requirements for USP and EP Purified Water and Water for Injection
  • Compare various technologies for production of WFI
  • Evaluate best sanitization methods for storage and distribution systems
  • Develop a risk-based plan for system qualification
  • Create a sampling matrix for a pharmaceutical water system Performance Qualification and Continuing Process Verification (CPV)
  • Compare and contrast international pharmacopeial and GMP requirements for pharmaceutical waters
  • Differentiate between regulatory expectations and good engineering practice
  • Define the baseline requirements for testing and monitoring
  • Design systems in accordance with regulatory expectations
  • Select appropriate technologies based on feed water quality and final water quality requirements

Standard

Member

On or before February 6, 2017
$2,249

After February 6, 2017
$2,499

Nonmember

On or before February 6, 2017
$2,699

After February 6, 2017
$2,999


Government/Health Authority/Academic

Member

$1,499

All rates in US Dollars. REFUND FOR COURSES: If your written request is received by February 20, 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 lecture 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:

Stephanie Ko
Senior Manager, Lecture Education
Tel: +1 (301) 656-5900 x151
Email: ko@pda.org

William Collentro, Senior Consultant, Pharmaceutical Water Specialists, LLC

Continuing Education for Pharmacists

ACPEPDA 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 #399 | ACPE #0116-0000-16-041-L04-P | 1.8 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 18 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 18 PDHs.

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