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Pre-Inspection Self Audits

Moving Beyond Checklists to Identify Real System Risks

** Registration to this course includes Trial access to TalkFDA Subscription and Members-only Community. Contact our Support for more details after the course completion.

This course equips teams to conduct pre-inspection self audits that identify real system risks, follow evidence trails, and convert findings into preventive actions before regulators uncover the same weaknesses. This Course is designed for professionals responsible for result assessment, investigation oversight, and quality decisions that must withstand regulatory review.

  • 05 June 2026
  • Eastern Time (US/Canada): 11.00 AM
  • GMT: 3.00 PM
  • 60 Minutes
  • FDB1604
  • Charles H. Paul
  • Live Session + Post-live Continued Learning
  • Live Q&A Included
  • Presentation Handout & Templates
  • Assessment & Certification Included

REGISTRATION OPTIONS

Live session Plus Complimentary 30 Days Streaming access

$190  |  One participant (viewer)

$590  |  Team of up to 10 participants

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Why take this course?

Pre-inspection self audits often fail because they confirm paperwork instead of testing whether the quality system works in practice. Teams may complete checklists, verify signatures, and confirm procedures exist while missing systemic weaknesses, recurring deviations, training gaps, data integrity issues, or ineffective controls. This creates false confidence until inspectors follow evidence trails and uncover risks the internal audit never challenged.

This program focuses on shifting internal audits from routine compliance confirmation to risk-based evaluation. It addresses how to use deviations, CAPA history, complaints, trends, and performance metrics to prioritize audit focus, plan realistic samples, interview personnel, trace records, and identify red flags. The emphasis is on finding vulnerabilities before regulators do and converting findings into preventive actions that strengthen systems rather than closing paperwork.

  • Audit processes instead of paperwork:

    This course helps teams move beyond static checklist review by testing how procedures work under real operational conditions. Participants learn to assess decisions, controls, records, and personnel understanding, reducing the risk that audits miss weaknesses later identified during FDA or EMA inspections.

  • Turn findings into prevention:

    Internal audit value depends on what happens after issues are found. This course strengthens how teams write evidence-based observations, distinguish symptoms from root causes, classify risk, and design sustainable controls. The result is fewer administrative CAPAs and stronger action against recurring system weaknesses.

Key Areas Covered

  • Why traditional internal audits miss meaningful system risks
  • Moving from calendar-based auditing to risk-based audit planning
  • Using deviations, CAPAs, complaints, trends, and performance metrics to select audit focus
  • Planning audits around evidence trails, operational flow, and realistic sampling
  • Simulating inspector-style questioning through records, interviews, and floor observation
  • Red-flag indicators including repeat issues, backlogs, training gaps, and data integrity weaknesses
  • Writing evidence-based observations and separating symptoms from root causes
  • Converting audit findings into preventive controls, effectiveness checks, and management review inputs

Who Must Attend

  • QA/QC Departments
  • Quality System Owners
  • CAPA and Investigation Leaders
  • Regulatory Affairs Departments
  • Compliance Professionals
  • Validation Departments
COURSE DIRECTOR

Charles H. Paul

Charles H. Paul has over 30 years of experience in regulatory consulting, manufacturing, training, and technical documentation. His work with domestic and international clients on complex training and documentation issues aligns directly with risk-based self audits, evidence-based observations, personnel readiness, and stronger inspection preparation across regulated operations.

If you would like to request a Proforma invoice to sign up for this course. please click here

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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Testimonials

This is an upcoming session. Feedback below reflects experiences from similar programs delivered by our expert faculty.

“Presenter didn’t overcomplicate things. Kept it moving. That helped keep the team engaged.”
- Director, Quality
“Flow was good. You could see the structure behind it. Not just information dump.”
- Engineer, Production
“Support team was quite responsive before the session. That made it easier to get aligned internally. Presenter kept things simple, not overloaded.”
- Manager, Regulatory Affairs

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