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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

Joseph E. McCall
Joseph E. McCall
ADMA Biologics
Bio
Joseph E. McCall
ADMA Biologics
Joe McCall, SM (NRCM) is the Director of Quality Assurance Technical Services at ADMA Biologics in Boca Raton, FL. He has over 25 years of experience as a professional microbiologist at such companies as Bausch & Lomb, Genzyme, DSM Pharmaceuticals, STERIS Life Sciences, and Mass Biologics. Joe has been an active industry member throughout his career, teaching courses at PDA TRI, the University of Tennessee HSC, and providing training at FDA CBER Division of Product Quality and Manufacturing. Joe has delivered training seminars in pharmaceutical microbiology for companies in Europe, Asia, South America, and across the US. He has been a proud member of PDA for nearly 20 years and is one of the few ASM Certified Specialists in Pharmaceutical and Medical Device Microbiology on the National Registry of Certified Microbiologists.
James N. Polarine, Jr.
James N. Polarine, Jr.
STERIS Corporation
Bio
James N. Polarine, Jr.
STERIS Corporation

Mr. Polarine is a senior technical service manager at STERIS Corporation. He has been with STERIS Corporation for over 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, the Middle East, Asia, and Latin America on issues related to cleaning and disinfection, microbial control in cleanrooms, and validation of disinfectants.   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 on the PDA’s COVID-19 Task Force. He was a co-author on PDA’s Technical Report #70 on cleaning and disinfection and Technical Report #88. Mr. Polarine teaches industry regulators with FDA, MHRA, HPRA, ANVISA, and ANMAT as well as the pharmaceutical, biotech, and medical device industries at the PDA and the University of Tennessee.   Mr. Polarine is current President for the PDA Missouri Valley Chapter and Technical Coordinator for the IEST.  Mr. Polarine graduated from the University of Illinois with a Master of Arts in Biology.  His main hobby involves storm chasing, 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

    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

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.

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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 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.

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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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