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PDA 443.1 Technical Report No. 3: Validation of Dry Heat Processes

Oct 07 - Oct 08, 2020
1:30 PM
-
4:30 PM
| Eastern Standard Time
Online
  • Virtual
  • Education
  • Online

Overview

This live elearning 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

Trainers

Deborah Havlik
Deborah Havlik
Hospira, Inc.

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

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

Departments
  • Quality Control (Microbiology)
  • Research and Development
  • Manufacturing
  • Quality Assurance Operations
  • Validation

Roles
  • Specialist
  • Operator/Technician
  • Supervisor
  • Manager
  • Engineer
  • Scientist

Registration Fees

Register Now
Registration Type Price
Member $600
Non-member $600
Gov't/Health Auth./Academic $600

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