Good Manufacturing Practice (GMP) and FDA Compliance Auditing

Operational Auditing and Quality Assurance October 25, 2025
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Introduction

This intensive course is designed for professionals who need to audit manufacturing operations for compliance with Good Manufacturing Practice (GMP) standards, particularly those enforced by the U.S. Food and Drug Administration (FDA). It provides a detailed review of the Code of Federal Regulations (CFR), focusing on parts related to quality systems, documentation, facilities, and process control. Participants will learn how to conduct a compliance audit that mirrors an FDA inspection, identifying potential 483 observations and warning letter risks. The training emphasizes the critical role of GMP in ensuring product safety, quality, and efficacy in regulated industries like pharmaceuticals, medical devices, and food.

Objectives

Upon completion of this course, participants will be able to:

  • Explain the legal framework and scope of GMP as enforced by the U.S. FDA (21 CFR).
  • Interpret the key requirements for Quality Systems (e.g., 21 CFR Part 820 for Medical Devices).
  • Apply audit techniques to assess facility design, equipment control, and sanitation practices.
  • Conduct effective audits of documentation practices, including batch records and validation protocols.
  • Identify critical non-compliances that are likely to result in FDA Form 483 observations.
  • Audit the processes for handling nonconforming product, complaints, and corrective/preventive actions (CAPA).
  • Understand the audit differences between internal audits, supplier audits, and regulatory inspections.
  • Prepare audit reports that clearly communicate compliance risk and proposed corrective measures.

Target Audience

  • Quality Assurance and Quality Control personnel in FDA-regulated industries.
  • Internal and Supplier Auditors for pharmaceutical, biotech, and medical device companies.
  • Regulatory Affairs and Compliance Specialists.
  • Manufacturing Supervisors and Process Engineers.
  • Consultants specializing in GMP and FDA compliance.
  • Top Management responsible for regulatory risk.

Methodology

  • Case Studies focused on actual FDA Form 483 observations and warning letters.
  • Group Activities: Auditing a sample batch record for GMP compliance gaps.
  • Role-Playing: Simulating an FDA interview and response strategies.
  • Practical Exercises in identifying data integrity failures in documentation.
  • Discussions on the legal and business consequences of major GMP violations.

Personal Impact

  • Gain specialized competence in auditing highly regulated GMP environments.
  • Develop skills to identify compliance gaps with the rigor of a regulatory inspector.
  • Enhance career prospects in Quality and Regulatory Affairs within the life sciences.
  • Improve ability to conduct robust supplier audits of critical material providers.
  • Confidence in preparing the organization for internal, customer, and regulatory inspections.
  • Master the interpretation of complex regulatory text (21 CFR).

Organizational Impact

  • Significant reduction in regulatory non-compliance and the risk of FDA action (483, Warning Letters).
  • Ensured product safety, quality, and efficacy, protecting consumers and the brand.
  • More robust quality system controls and documentation practices.
  • Improved efficiency in manufacturing by ensuring consistent, controlled processes.
  • Stronger compliance posture and faster response capability to regulatory inquiries.
  • Avoidance of costly product recalls and market withdrawal expenses.

Course Outline

Unit 1: The Regulatory Landscape and GMP Fundamentals

Section 1.1: FDA and GMP Framework
  • Overview of the U.S. FDA, its authority, and the role of the CFR in GMP compliance.
  • Interpreting the general principles of GMP across different regulated sectors (e.g., Part 210/211, Part 820).
  • The importance of the Quality System Regulation (QSR) and the role of quality unit independence.
  • Auditing the control of incoming materials and components.

Unit 2: Auditing Facility, Equipment, and Process Control

Section 2.1: Physical and Operational Audits
  • Auditing facility design, maintenance, cleaning, and environmental controls.
  • Techniques for auditing equipment calibration, validation, and maintenance records.
  • Auditing the control of manufacturing operations and critical process parameters.
  • Auditing sampling procedures and laboratory controls (GLP principles).

Unit 3: Auditing the Quality System Documentation

Section 3.1: Documentation Integrity
  • Auditing the control of documents and records (electronic and paper).
  • Reviewing Batch Production Records (BPR) and Device History Records (DHR) for completeness.
  • Auditing data integrity principles (ALCOA+).
  • Auditing training and personnel qualification records.

Unit 4: Auditing Core Quality Subsystems

Section 4.1: CAPA and Nonconformance
  • Auditing the handling and disposition of nonconforming materials and finished products.
  • Auditing the Complaint Handling and Medical Device Reporting (MDR) systems.
  • In-depth auditing of the Corrective and Preventive Action (CAPA) process effectiveness.
  • Auditing management review and quality system review activities.

Unit 5: FDA Inspection Readiness and Reporting

Section 5.1: Compliance Reporting and Follow-up
  • Simulating an FDA inspection and understanding investigator authority.
  • Identifying and documenting potential 483 observations and critical non-compliances.
  • Structuring the audit report to communicate regulatory risk clearly.
  • Auditing the follow-up process to address regulatory findings (e.g., warning letter responses).

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