This course enables participants to understand how FDA selects inspection targets, how FDA evaluates quality system health before arrival, and how to build a continuous state of control aligned with FDA expectations under 21 CFR regulations.
Why This Training Matters
This course concentrates on pre-inspection readiness—what FDA evaluates long before the investigator presents FDA Form 482. Participants explore the FDA’s risk-based inspection philosophy, including how internal Agency models prioritize sites for inspection and how seemingly minor data inconsistencies can elevate inspection scope. The session examines what FDA truly means by being “inspection ready,” emphasizing the difference between having procedures in place and demonstrating real-world process control. Special attention is given to documentation practices, investigation quality, CAPA effectiveness, and management oversight, all of which are consistently cited in FDA Form 483 observations when they fail to demonstrate control.
Agenda:
Lecture 1 - The FDA Inspection Model Today
- FDA’s risk-based inspection approach under FDA’s Site Selection Model
- How FDA uses registration data, submissions, recalls, and prior history
- Difference between routine surveillance and “for-cause” inspections
Key FDA References
- FDA Compliance Program Guidance Manuals (CPGMs)
- FDA Risk-Based Site Selection Model (public descriptions)
Lecture 2 - What FDA Means by “Inspection Ready”
- FDA’s expectation of a continuous state of control
- Why passing a prior inspection does not indicate current compliance
- FDA focus on process control, not document presence
Key Regulations
- 21 CFR Part 210/211 (Drugs)
- 21 CFR Part 820 / QMSR transition considerations (Devices)
Lecture 3 - FDA Data Signals That Drive Inspection Focus
- How FDA evaluates:
- Deviations and investigations
- CAPA effectiveness
- OOS/OOT trends
- Complaints and MDRs
- What inconsistent trending tells an investigator
Key FDA Guidance
- FDA Guidance on Investigating OOS Results
- FDA Quality Systems Inspection Technique (QSIT)
Lecture 4 - Documentation FDA Relies on to Assess Control
- Good Documentation Practices as interpreted by FDA investigators
- Common documentation deficiencies cited in FDA 483s
- How FDA evaluates:
- Root cause quality
- CAPA linkage
- Management oversight documentation
Key Regulations
- 21 CFR 211.100, 211.192
- 21 CFR 820.70, 820.100
Lecture 5 - FDA-Focused Readiness Assessments
- Why internal audits often fail to predict FDA outcomes
- Aligning readiness assessments to FDA inspection techniques
- Using prior FDA 483 trends to assess site vulnerability
Lecture 6 - Management Responsibility Under FDA Scrutiny
- FDA expectations for executive oversight
- How FDA evaluates management knowledge and engagement
- Common leadership missteps cited during inspections
Key Regulations
- 21 CFR 211.22
- 21 CFR 820.20
Wrap-Up and Transition to Module 2
- Key readiness gaps FDA consistently identifies
- Preparing for investigator interaction and inspection execution
- Setting expectations for real-time inspection control
This is Module 1 of Practitioner Course "FDA Inspection Readiness - Modular Course for Practitioners".
You can either sign up only for this Module here.
Or the entire course → Here
Who This Training Is Designed For
- Quality Assurance Departments
- Quality Control Departments
- Quality Systems Manager
- Regulatory Affairs Departments
- Compliance Departments
- Manufacturing Departments
- Operations Departments
- Production Departments
- Engineering Departments
- Validation Managers
- Process Development Leads
- Maintenance and Facilities Managers
- Calibration and Metrology Managers
- Laboratory Managers
- Analytical Development Leads
- Stability Program Managers
- Microbiology Supervisors
- Data Integrity Leads
- Training Managers
- Document Control Managers
- Supplier Quality Managers
- Complaint Handling Managers
- CAPA Program Owners
- Change Control Managers
Course Director: Charles H. Paul
Charles H. Paul is the President of CHP Consulting LLC – a regulatory, training, and technical documentation consulting firm. Charles has been a regulatory consultant for over 25 years and has published numerous white papers on varies subject from project management and technical writing to regulatory compliance in the life sciences. The firm works with both domestic and international clients designing solutions for complex training and documentation issues within the life sciences.