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Technical Report No. 3: Validation of Dry Heat Processes

May 11, 2020
Bethesda, MD

  • Education
  • The Americas
Closed

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 Courses

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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

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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.

Directions

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 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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Tel: +1 (301) 656-5900
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Tel: +49 (0) 30 43 655 08-10

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