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Shutdown Recovery and Disinfectant Effectiveness Studies for Controlled Environments

Jun 25, 2019
Bethesda, MD

  • Education
  • Western Hemisphere Events
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Overview

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

  • 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, Ireland’s National Institute for Bioprocess Research & Training, and the University of Tennessee Health Science Center’s Aseptic Processing Training course. He is a vetted member of the US FDA’s Network of Experts program, US Technical Advisory Group to ISO Technical Committee 209 (Cleanrooms and Associated Controlled Environments), an ASQ certified Six Sigma Green Belt, and is one of only 32 professional microbiologists globally to attain the American Society for Microbiology (ASM) certification as a Specialist Microbiologist in Pharmaceutical and Medical Device Microbiology.
James Polarine, Jr. MA
James Polarine, Jr. MA
Steris Corporation
Bio
James Polarine, Jr. MA
Steris Corporation

Mr. Polarine is a Senior Technical Service Manager at STERIS Corporation. He has been with STERIS Corporation for eighteen 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 in cleanrooms. Mr. Polarine is a frequent industry speaker and published several PDA book chapters and articles pertaining 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 the cleaning and disinfection course module at the PDA Aseptic Processing Course and at the University of Tennessee’s Parenteral Medications Course. Mr. Polarine is currently President-Elect 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

  • 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: 594 / 0116-0000-19-018-L04-P / 0.6
    Type of Activity: Application

    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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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 May 10, 2019
Member $1,259
Non-member $1,511
Gov't/Health Auth./Academic* $839











Regular Registration
Registration Type Price After May 10, 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 May 25, 2019, no fee will be charged. After May 25, 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 May 25, 2019, a full refund will be given minus a $200 fee. After May 25, 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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