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Technical Report No. 3: Validation of Dry Heat Processes

May 11, 2020
Bethesda, MD

  • Education
  • The Americas
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Overview

This training course focuses on the microbiology and principles for qualification of dry heat sterilization and depyrogenation processes as well as the general approach to sterilization and depyrogenation science in batch and continuous sterilizers (ovens and tunnels). Current industry practices and approaches to validating dry heat depyrogenation processes will be covered in addition to various aspects of dry heat as a sterilization process. Points to consider in equipment design, equipment verification, process development and performance qualification for new systems and the development and validation of processes for existing systems will also be discussed.

Participants will understand equipment options and the factors for consideration in qualification, validation and ongoing maintenance. During this training course, participants will learn about the use and limitations of endotoxin indicators and biological indicators and the calculations used to determine inactivation of both types of challenges. Participants will have an opportunity to discuss actual problems encountered and consider causes and possible solutions.

For more options and/or related training courses, please visit the page(s) below.

PDA Sterilization Training Course Series

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Agenda

  • An agenda will be available soon. Training courses generally run from 8:30 to 16:00 each day. Breakfast will not be provided, but lunch will be provided.

Trainers

Deborah Havlik
Deborah Havlik
Hospira, Inc.
Bio
Deborah Havlik
Hospira, Inc.

Ms. Havlik has been with Hospira, Inc. since 2000 in the Microbiology group of Pharmaceutical Research and Development. The group has responsibility for global microbiological and sterilization issues related to new product development and marketed product, including regulatory submissions.

Ms. Havlik has been actively involved in the development of sterilization standards and technical reports on a national and international basis for more than eighteen years.  She has led and contributed to a PDA task force on dry heat and AAMI working groups that have written concensus standards in microbiological methods, ethylene oxide, radiation, and dry heat sterilization. She currently represents the U.S. on the ISO Microbiological Methods working group, and is the convenor of the ISO Dry Heat Sterilization working group.

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Explain the concepts and methods in the validation of dry heat processes
    2. Discuss current industry practices and approaches to validating dry heat depyrogenation processes
    3. Identify load type, loading patterns and temperature profiles for depyrogenation and sterilization
    4. Interpret results and adjust or problem shoot as necessary
    5. Demonstrate competence in ability to conduct successful validation of dry heat processes
  • Who Should Attend

    Who Should Attend

    This training course is intended for professionals who are responsible for the validation of dry heat processes used in sterile drug manufacturing.

    Departments
    Quality Assurance, Validation, Manufacturing, Quality Control, Process Development

    Roles
    Specialist, Scientist, Supervisor, Manager, Technician, Engineer

  • 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: 443 / 0116-0000-19-044-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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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 March 27, 2020
Member $1,259
Non-member $1,511
Gov't/Health Auth./Academic* $979

Regular Registration
Registration Type Price After March 27, 2020
Member $1,399
Non-member $1,679
Gov't/Health Auth./Academic* $979


* 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.

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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).

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SUBSTITUTION: If a substitution request is sent by Apr 11, 2020, no fee will be charged. After Apr 11, 2020, 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 Apr 11, 2020, a full refund will be given minus a $200 fee. After Apr 11, 2020, 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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