FDA Inspection Readiness (GMP Auditing)

How To Be An Effective GMP Auditor – Part 3

The US Food and Drug Administration (FDA) is responsible for regulating the safety, efficacy, and quality of therapeutic products that save or improve human lives. Firms looking to approve pharmaceuticals, biopharmaceuticals, and medical devices must comply with these regulations or face sanctions and/or setbacks. FDA pre-approval inspections will focus on the past (corroboration of the data on which approval will be based), present (your organizational structure, delegation of responsibilities, written procedures, quality systems, culture of compliance) and future (your understanding and readiness for post-approval statutory obligations, including commercial vigilance plans).

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CEU Credits: 0.1
Course Code: ELM-124
Duration: 45 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.0

Curriculum for this course

Overview
Learning objectives
Who should take this course?
Course modules
What is an audit?
Why GMP audit?
Safety, business and compliance
Types of GMP audits
Internal audit (Self inspection)
Regulatory audits
Who conducts GMP audits?
Key principles of GMP audits – Auditors
Key Principles of GMP audits – Process
Benefits of GMP audits
The GMP audit process
Determine the basis for the audit
What is the purpose of the audit?
What is your role?
What are the standards?
What is the scope?
Determine the feasibility of the audit
Review documents
Prepare the audit plan
Audit plan communication
Prepare work documents
The audit process
The opening meeting
Avoid unproductive meetings
The site area tour
Collect information
Interviews
Records review
Observations
Beginning the conference room pilot
Auditing techniques
Horizontal auditing
Vertical auditing
The ideal combination
Other auditing techniques
General audit findings
The daily wrap up
Classify audit observations
Critical deficiency
Major deficiency
Minor/Other deficiency
The close-out meeting
Preparation of the audit report
Report comments
What should not be in the report
Approve and distribute the audit report
Conduct follow up audit

Phase 4: Audit Closure

Typical systems
Quality assurance system
Validation / qualification system
Material system
Premises and equipment systems
Packaging and labelling systems
Laboratory control systems (LIMS)
Research and development systems (R&D)
Engineering and maintenance systems
Utilities systems
Warehousing systems
How to be a successful auditor
Professional experience
Knowledge and skills
Audit principles
Management systems and references
Organizational situations
Law and regulatory requirements
Personal suitability
Difficult situations
Examples of GMP non-compliance
Quality systems
Facility systems
Equipment systems
Material systems
Production and process control systems
Packaging and labelling
Laboratory control systems
Organizational and personnel
Records and reports
Returned and salvaged products

Conclusion

Final Assessment

Certification

Updated name from "FDA Inspection Readiness – Part 3" to "How to be an Effective GMP Auditor – Part 3"
V2.0
Redesigned course with new Articulate Storyline player
V2.0
Added new final exam question to align with learning objectives
V2.0
Updated Glossary links
V2.0

Author

Joginder Mittal

Manager - Quality Compliance Glatt Pharma Engineering

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