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    • AI Essentials for Life Science Writers
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    • Preparing for an FDA Audit
    • QMSR Readiness
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    • Single-Use Technology in Pharma and Bio
    • Understanding and Implementing Annex 1
    • Understanding Cleanrooms
    • Upstream Processing Overview
    • Validation Fundamentals
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Understanding Cleanrooms

course description

This four-hour course covers the basics of cleanrooms and cleanroom technology, which is an engineering control used to protect end-users (patients). Regulatory agencies are keen to evaluate the environment where products are manufactured, which can impact the sterility and integrity of the medicines used to treat patients. Several aspects of cleanrooms will be discussed, including what cleanrooms are, the regulatory requirements for cleanrooms depending on the product, how cleanrooms are used, how they are constructed, and how they are monitored to meet cleanliness expectations. A discussion of cleanroom standards and guidelines will be presented, including both non-viable particulate and viable contamination, and will be used in the evaluation of cleanrooms.
course specifics:
  • Participant Cap - 30
  • Delivery - Face-to-face or Virtual
  • Course Length - Four (4) hours
  • Printed Materials - Sent to company or college prior to delivery for them to print and disseminate
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