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

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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

  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

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Standard Pricing

Standard Member Price

$200

GovernmentMember Only

$200

Health AuthorityMember Only

$200

AcademicMember Only

$200

Non-Member

$200

See Qualifying Criteria for Member Types.

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