Equipment Qualification and Process Validation Training

  • Instructor : Dr. Loren Gelber
  • Level : Intermediate
  • Study time : 76 minutes
  • Course ID: TF2953
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ABOUT THE COURSE

Are your IQ/OQ/PQ protocols audit-ready and in sync with FDA expectations?
Could changes to equipment or cleaning processes trigger requalification issues?
Do you know what FDA looks for—written and unwritten—during inspections?


Whether you validate, qualify, or host audits—this session gives you clarity, structure, and expert-backed confidence to meet FDA scrutiny head-on.


WHAT WILL YOU GAIN
  • Clear guidance on equipment qualification (IQ, OQ, PQ) and documentation flow
  • Understanding of when and how to revalidate processes and cleanings
  • Knowledge of common FDA pitfalls—so you can avoid 483s before they happen


WHY TAKE THIS COURSE
  • Qualify and validate smarter, with FDA insights no SOP will tell you
  • Build inspection-ready systems without overcomplicating compliance
  • Align cross-functional teams with one cohesive qualification framework


KEY AREAS COVERED
  • FDA expectations for GMP-compliant qualification and validation
  • Detailed breakdown of IQ, OQ, PQ and their proper sequencing
  • Computer System Qualification and 21 CFR Part 11 compliance
  • Best practices for manufacturing and cleaning process validation
  • Setting and justifying test specifications and sample sizes
  • When, what, and how much to test—without over- or under-doing it

Quality training, expert insights, and answers that matter. Know your Expert

Dr. LOREN GELBER

Dr. Loren Gelber has seen qualification and validation from every angle—inside the FDA, across top pharma companies, and as a trusted compliance consultant. Her 40+ years of experience give her a sharp understanding of what regulators actually want to see. If your team touches systems, specs, or audits, her guidance is the edge you need.

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