GMP Auditing for Quality Assurance Training Course for FDA Regulated Industries | Key Skills, cGMP Knowledge, and Effective Audit Execution Strategies (ONLINE EVENT: August 21-22, 2025) - ResearchAndMarkets.com

DUBLIN--(BUSINESS WIRE)--The "GMP Auditing for Quality Assurance Training Course for FDA Regulated Industries" training has been added to ResearchAndMarkets.com's offering.

Auditing is a critical function within a pharmaceutical company. It provides management with information about how effectively the company controls the quality of their processes and products. Auditors must perform their jobs competently to ensure their company's compliance with pharmaceutical USFDA GMP regulations and other quality standards like ICH Q10. This Auditing for GMP course is specifically designed to address the challenges of GMP auditing for the pharmaceutical industry and present the basic competencies required to effectively perform the auditor's assigned responsibilities.

Learning Objectives:

• Effectively evaluate audit and report findings
• Identify critical components for a good audit report
• Conduct an audit using an audit trail and checklist
• Understand the concepts behind compliance auditing
• Increased knowledge of cGMP concepts and regulatory requirements related to auditing
• Prepare and conduct audits using an audit trail and checklists
• Identify the critical competencies needed to be a conscientious auditor

RAPS - This course has been pre-approved by RAPS as eligible for up to 8.0 credits towards a participant's RAC recertification upon full completion.

Who Should Attend:

• Quality Assurance & Quality Control (QA/QC) professionals
• Regulatory compliance managers
• Manufacturing & production supervisors
• GMP auditors & consultants
• Anyone responsible for GMP compliance in pharmaceuticals, supplements, or food industries

Key Topics Covered:

Day 1: Foundations of GMP Auditing & Regulatory Requirements

Welcome & Course Introduction

• Overview of GMP and its importance in quality assurance
• Understanding the role of auditing in compliance & risk management

GMP Regulatory Frameworks

• FDA, EU GMP, WHO, PIC/S, and other global guidelines
• Key differences and harmonization efforts

Types of GMP Audits & Audit Planning

• Internal audits vs. supplier audits vs. regulatory inspections
• Developing an effective audit plan & checklist

Conducting a GMP Audit - Step-by-Step Guide

• Opening meetings & setting audit objectives
• Interview techniques & document review best practices

Identifying Non-Conformities & Risk Assessment

• Categorizing major vs. minor observations
• Evaluating risk impact & root cause analysis

Q&A & Recap of Day 1

Day 2: Corrective Actions, CAPA, & Regulatory Inspections

Recap of Day 1 & Key Takeaways

Writing Effective Audit Reports

• Key elements of a strong audit report
• Using clear, objective, and actionable language

Coffee Break

CAPA (Corrective and Preventive Actions) Implementation

• Addressing audit findings with root cause analysis
• Developing CAPA plans & ensuring follow-ups

Preparing for Regulatory Inspections

• Mock audits & real-world case studies
• How to respond to FDA/EU regulatory auditors

Speakers:

Kelly Thomas

Vice President

Stallergenes Greer

Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.

Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.

For more information about this training visit https://www.researchandmarkets.com/r/uxy72l

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