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Top Process Validation Mistakes - And How to Avoid Them

This course strengthens your ability to plan, execute, and manage process validations that satisfy regulatory expectations while improving process consistency. It helps reduce validation-related compliance gaps, development delays, product quality issues, and inspection exposure through practical validation planning and qualification practices. This Course is designed for professionals responsible for process control, product quality, validation activities, and regulatory compliance oversight.

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US $190 per learner

30-Days Unlimited Streaming Access

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REGISTER FOR THE COURSE

To Get 30-Day Access to ONLY this Course 

US $190 per learner
  • This course is Included in Subscription Pack
Subscription include access to entire Learning Library
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  • Instructor : Susanne Manz
  • Study time : 90 Minutes
  • Skill Level: Intermediate
  • Course ID: TF2628
  • Assessment & Certification Included
  • Ask the Expert

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About the Course

Process validation remains a critical requirement under Quality System Regulations and ISO13485 because manufacturers must demonstrate that processes consistently achieve predetermined specifications. Weak validation practices frequently contribute to FDA 483 observations, product quality concerns, customer complaints, adverse events, and recalls. Delays in development and operational inefficiencies can also result when validation activities are poorly planned or inadequately documented. Clear validation planning, protocol development, qualification activities, and controlled change management are therefore essential for maintaining process stability and inspection readiness.


The course addresses validation planning, verification and validation decision-making, and the practical execution of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Regulatory expectations, enforcement lessons, and quality system linkages are examined alongside common process validation mistakes that create compliance exposure. Attention is also given to best practices that support consistent execution, controlled process changes, and reliable validation outcomes across regulated operations.

  • Strengthen Validation Execution and Inspection Readiness:

    Effective validation requires more than completing protocols or qualification documents. This course clarifies when verification or validation is appropriate, how IQ, OQ, and PQ activities should be structured, and where companies commonly fail during implementation. Stronger execution practices can reduce inspection findings, prevent avoidable validation delays, and improve consistency across regulated manufacturing and operational processes.

  • Improve Process Stability Through Controlled Validation Practices:

    Process instability and poorly managed changes can create product quality issues, customer complaints, and increased regulatory scrutiny. The course explains validation planning, protocol development, and change management practices that support repeatable process performance. Participants gain practical insight into maintaining documented control, aligning validation activities with quality system requirements, and avoiding recurring compliance weaknesses identified during enforcement actions.

Key Areas Covered

  • Purpose, scope, and operational value of process validation within regulated quality systems
  • FDA expectations, Quality System Regulations, and ISO13485 validation requirements
  • Common process validation mistakes linked to compliance observations and quality issues
  • Verification versus validation decision-making for regulated manufacturing and operational activities
  • Validation planning, protocol writing, and change management practices
  • Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) execution principles
  • Linkages between validation activities and broader quality system controls
  • Enforcement case studies, lessons learned, and process validation best practices

Who Must Attend

  • Manufacturing Engineers
  • Quality Managers
  • Auditors
  • QC Analysts
  • Compliance Professionals
  • Validation Specialists

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

SUSANNE MANZ

Susanne Manz has extensive experience in medical device quality and compliance across new product development, operations, and post-market activities. Her background includes process and quality system implementation supported by Six Sigma Black Belt and Master Black Belt certifications earned at Johnson and Johnson. She also holds Regulatory Affairs Certification (RAC) and Certified Quality Auditor (CQA) credentials. Her engineering, compliance, and operational experience directly supports the practical validation, qualification, and quality system topics addressed in this course.

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“Presenter didn’t overcomplicate things. Kept it moving. That helped keep the team engaged.”

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