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Shutdown Recovery and Disinfectant Effectiveness Studies for Controlled Environments

Oct 29, 2019
Bethesda, MD

  • Education
  • The Americas
Closed

Overview

DATE CHANGE
Please be advised that training course 594 Shutdown Recovery and Disinfectant Effectiveness Studies for Controlled Environments has been rescheduled to Oct 29.

This new training course addresses strategies for development of a “Shutdown Recovery Plan” for cleanroom manufacturing operations after a loss of environmental controls (planned and unplanned). This training course will cover fundamentals of environmental control and present key factors to consider to regain sufficient levels of microbial control after periodic shutdown of manufacturing facilities, as well as proven strategies to address unplanned loss of environmental controls after such events such as power-outages, mechanical failure, structural damages, and natural disasters.

A cornerstone element of environmental control programs is cleaning and disinfection; this training course will thoroughly cover the requisites of selection, qualification, and implementation of chemical disinfectants in order to establish a robust and compliant cleaning and disinfection program. There will be a special focus on Disinfectant Effectiveness (DE) studies including in-house and Contract Lab performance of DE studies, parameters of a suitable DE study, acceptance criteria, regulatory expectations, and tools for assessing and interpreting DE study data.

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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

Joe McCall
Joe McCall
STERIS Life Sciences
Bio
Joe McCall
STERIS Life Sciences

Joe is a Technical Service Specialist with STERIS Life Sciences. He specializes in microbial control, environmental monitoring, contamination investigations and cleanroom issues. Joe has over 20 years of experience in the biopharmaceutical and medical device industries, specializing in aseptic processing, cleanroom qualification, environmental monitoring, and risk management. He is based in South Carolina USA and provides global technical support and expert consultation services for Critical Environments. Joe is an invited conference speaker on pharmaceutical microbiology topics at Pharmaceutical Microbiology Forum (PMF), PDA, A3P Belgium, ISCC, and is a course instructor at PDA, NIBRT in Ireland, and the University of Tennessee HSC’s Aseptic Processing Training course. He is a vetted member of the US FDA’s Network of Experts program, voting member of US Technical Advisory Group to ISO Technical Committee 209 (14644 Cleanrooms and Associated Controlled Environments), an ASQ certified Six Sigma Green Belt, and is one of only a handful of professional microbiologists worldwide to attain the American Society for Microbiology (ASM) certification as a Specialist Microbiologist in Pharmaceutical and Medical Device Microbiology.
Jim N. Polarine
Jim N. Polarine
STERIS Corporation
Bio
Jim N. Polarine
STERIS Corporation

Mr. Polarine is a senior technical service manager at STERIS Corporation. He has been with STERIS Corporation for twenty years. His current technical focus is microbial control in cleanrooms and other critical environments. Mr. Polarine is a 2019 PDA Michael S. Korczynski Award recipient. He has lectured in North America, Europe, Middle East, Asia, and Latin America on issues related to cleaning and disinfection and microbial control in cleanrooms. Mr. Polarine is a frequent industry speaker and published several PDA book chapters and articles related to cleaning and disinfection and contamination control. He is active as co-chair on the PDA’s microbial investigations task force. He was a co-author on PDA’s Technical Report #70 on Cleaning and Disinfection. Mr. Polarine teaches industry regulators as well as the pharmaceutical, biotech, and medical device industries at the PDA and the University of Tennessee. Mr. Polarine currently teaches the cleaning and disinfection course as part of the PDA’s Aseptic Processing Course and at the University of Tennessee’s Parenteral Medications Course. Mr. Polarine is current President for the PDA Missouri Valley and Technical Coordinator for the IEST. Mr. Polarine graduated from the University of Illinois with a Master of Arts in Biology. He previously worked as a clinical research coordinator with the Department of Veterans Affairs in St. Louis, MO and as a biology and microbiology instructor at the University of Illinois. His main hobby is storm chasing and is very active in tornado research and tornado safety.

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Develop a shutdown recovery plan, and/or assess the scientific integrity of their current plan
    2. Develop and deploy a pre- and post-shutdown monitoring plan that definitively demonstrates suitable environmental control has been re-established after a planned or unplanned loss of aseptic control
    3. Describe disinfectant cleaning programs for regulated manufacturing environments and assess your own facility’s cleaning and disinfection program
    4. Explain regulatory requirements and expectations in the US and Europe, specifically regarding response plans for planned and un-planned shutdowns, disinfectant qualifications, and continuous improvement assessments
    5. Evaluate DE test protocols for suitability and accurately interpret disinfectant effectiveness test data
  • Who Should Attend

    Who Should Attend

    This training course is intended for professionals who are responsible for cleanroom manufacturing operations after a loss of environmental controls.

    Departments
    Facilities, Engineering, Validation, Quality Assurance, Quality Control, Manufacturing

    Roles
    Engineer, Specialist, Analyst, Technician, Supervisor, Manager

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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 September 13, 2019
Member $1,259
Non-member $1,511
Gov't/Health Auth./Academic* $839



Regular Registration
Registration Type Price After September 13, 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 [email protected] or +1 (301) 656-5900.

SUBSTITUTION: If a substitution request is sent by Sep 28, 2019, no fee will be charged. After Sep 28, 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 Sep 28, 2019, a full refund will be given minus a $200 fee. After Sep 28, 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: +1 (301) 656-5900
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Tel: +49 (0) 30 43 655 08-10

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