COURSE - INSTANT STREAMING ACCESS
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Corrective Actions Preventive Actions - CAPA 101

This course equips professionals to identify root causes effectively, implement meaningful corrective and preventive actions, and strengthen quality system performance across pharmaceutical and medical device manufacturing operations. This Course is designed for professionals responsible for quality systems, manufacturing performance, product investigations, and compliance activities.

REGISTER FOR THE COURSE

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 : Alan M. Golden
  • Study time : 60 Minutes
  • Skill Level: Intermediate
  • Course ID: TF3598
  • Assessment & Certification Included
  • Ask the Expert

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About the Course

Corrective and preventive actions play a central role in maintaining product quality and manufacturing consistency within pharmaceutical and medical device operations. Weak investigations, incomplete root cause analysis, or ineffective corrective measures can allow recurring issues to persist, creating operational disruptions and increasing quality system exposure. A structured CAPA process supports timely issue resolution while reinforcing control over manufacturing and quality activities.


Establishing an effective CAPA system requires more than documenting nonconformances. Organizations must understand how quality events enter the CAPA process, how investigations are performed, and how corrective and preventive actions are evaluated for effectiveness. Clear procedures and disciplined execution are essential to maintaining reliable product performance and supporting ongoing manufacturing continuity. This course addresses the practical elements required to build and maintain a CAPA process that supports quality system expectations in regulated environments while improving consistency in issue management and resolution.

  • Root Cause Investigation and CAPA Execution:

    Effective CAPA activities depend on accurately identifying the source of quality or manufacturing problems rather than addressing isolated symptoms. This course strengthens the ability to evaluate investigation inputs, determine appropriate corrective actions, and establish preventive measures that reduce recurrence. Strong execution in this area supports product consistency and reduces operational exposure associated with unresolved quality issues.

  • Building a Reliable CAPA Process:

    Organizations are expected to maintain controlled and repeatable processes for managing quality events and implementing corrections. This course clarifies the operational structure required for a functioning CAPA system, including process inputs, investigation flow, and action management. A well-defined CAPA process improves consistency across manufacturing and quality operations while supporting ongoing quality system performance.

Key Areas Covered

  • Fundamental principles and operational purpose of corrective and preventive action systems
  • Root cause investigation practices for product and manufacturing quality issues
  • Inputs and quality events that initiate CAPA activities
  • Establishing corrective actions that address identified causes effectively
  • Developing preventive actions to reduce recurrence of quality problems
  • Building structured CAPA procedures within pharmaceutical and medical device quality systems

Who Must Attend

  • Quality Assurance Professionals
  • Quality Control Teams
  • Regulatory Affairs Specialists
  • Research & Development Personnel
  • Manufacturing Operations Teams
  • Engineering Professionals

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

ALAN M. GOLDEN

Alan has more than 30 years of experience in medical device research, quality assurance, and regulated manufacturing operations. During his career at Abbott Laboratories, he worked extensively in quality assurance activities involving CAPA, change control, risk management, validation, and quality systems support for product development and operations. His background includes implementing quality processes across diagnostics and molecular divisions, along with delivering global training programs focused on regulated quality system practices.

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Ready to Strengthen Your Team? Let’s Build Your Training Plan.

Whether you’re looking for a single onsite workshop or a multi-team training series, we’ll help you design a program that fits your goals, timelines, and operational reality.

Your team deserves the clarity.
Your organization deserves the confidence.

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Our students love us ❤️

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

Director, Manufacturing

“Good balance. Not too basic, not too deep. Worked well for mixed team.”

Manager, Regulatory Affairs

“Support team followed up properly. That part is usually missing elsewhere.”

Supervisor, Training and Development

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