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Live eLearning - PDA 709 Using a Risk-Based Approach to Successfully Qualify Your Machine

Aug 11, 2020
1:30 PM
-
3:30 PM
| Eastern Standard Time
Online
  • Education
  • Virtual
  • Online
Closed

Overview

This training course will review the necessary tests, FAT, SAT, Commissioning, IQ and OQ, that are performed during the qualification of a sterilizer or pharmaceutical machine. We will go in depth regarding the requirements and regulations, as well as evaluate Fedegari Group’s testing examples. We will also look at other significant steps during the manufacturing and quality control processes that play a huge role in obtaining the desired qualification results. We will discuss the necessary checkpoints during a FAT and how to even perform a virtual and paperless FAT during these unprecedented times.

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

PDA Sterilization Training Courses

Trainers

Samantha Kay
Samantha Kay
Fedegari Technologies, Inc.
Pierre Winnepenninckx
Pierre Winnepenninckx
No deviation Pte. Ltd.

Learning Objectives

  1. Understand critical elements of the equipment manufacturing process
  2. Identify crucial inspection and test points
  3. Create quality value out of Supplier testing to guarantee the success of inspection such as FAT, IQ and OQ
  4. Understand concept of quality by design and front-end loading testing
  5. Perform a risk assessment of the machine qualification process, especially for customized requirements
  6. Review example IOQ test protocols

Who Should Attend

This training course is intended for professionals who want to expand their knowledge on the FAT, IQ and OQ tests, or who seek to create more value out of the C&Q activities.

Departments
  • Quality Control (Analytical)
  • Quality Systems
  • Quality Compliance
  • Engineering
  • Manufacturing
  • Quality Assurance Operations
  • Regulatory Affairs
  • Technical Operations
  • Training
  • Validation
  • Facilities

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

Registration Fees

Closed
Registration Type Price
Member $200
Non-member $200
Gov't/Health Auth./Academic $200

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