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Contamination Control, Clean Room Design, and Environmental Monitoring for Controlled Environments - Option 1

Aug 12, 2019
Bethesda, MD

  • Education
  • Western Hemisphere Events
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Overview

This training course will provide a comprehensive understanding of clean room design as it applies to ongoing operation, as well as the knowledge to develop a contamination control strategy and implement an environmental monitoring program for controlled environments. Case studies and practice failure investigations will be used to demonstrate common errors to avoid as well as best practices to implement. The participants will gain an understanding of how design, control, and monitoring work together to provide the required manufacturing environment, which will allow the participants to identify opportunities for improvement within their companies. Participants will also learn how to investigate excursions when they occur.

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Agenda

  • Training courses run from 8:30 to 16:00 each day, unless otherwise noted. An agenda will be provided on the first day of the training course.

Trainers

Robert Ferer
Robert Ferer
Quality Executive Partners, Inc.
Bio
Robert Ferer
Quality Executive Partners, Inc.

Robert (Bob) Ferer is the Practice Lead responsible for Engineering and Operations at Quality Executive Partners Inc. A graduate of the State University of New York at Stony Brook, Bob is an engineering chemist and has more than 25 years direct industry experience including the design, build, start-up, and management of facilities, specializing in aseptic manufacturing. His operational experience covers all aspects of pharmaceutical operations from receipt of raw materials through inspection, final packaging, and shipping of finished products. In addition to operations expertise, Bob was instrumental in multiple new facility design and start up projects which included developing and executing project master plans, schedules, and budgets; performing hands-on validation, design review, and equipment start up and commissioning. As a consultant, Bob provides high-level consultation to clients on regulatory and compliance issues related to operations, engineering, and facility design for US as well as EU markets.

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Identify elements of clean room design critical to successful operation
    2. Explain how a contamination control program complements the environmental monitoring program
    3. Determine the key elements in a contamination control program
    4. Identify sampling locations for the environmental monitoring program
    5. Investigate environmental monitoring excursions and identify potential root causes
  • Who Should Attend

    Who Should Attend

    This training course is intended for professionals who are involved in contamination control strategy development for sterile drug manufacturing.

    Departments
    Engineering, Quality Assurance, Quality Control

    Roles
    Engineer, Specialist, Analyst, Supervisor, Manager

  • 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: 357 / 0116-0000-15-29-L04-P / 0.6
    Type of Activity: Knowledge

    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 6 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 6 PDH credits.

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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 June 28, 2019
Member $1,259
Non-member $1,511
Gov't/Health Auth./Academic* $839








Regular Registration
Registration Type Price After June 28, 2019
Member $1,399
Non-member $1,679
Gov't/Health Auth./Academic* $839








* 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 registration@pda.org or +1 (301) 656-5900.

SUBSTITUTION: If a substitution request is sent by Jul 13, 2019, no fee will be charged. After Jul 13, 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 Jul 13, 2019, a full refund will be given minus a $200 fee. After Jul 13, 2019, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to registration@pda.org. Phone messages are not accepted.

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Tel: +49 (0) 30 43 655 08-10

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