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GMP Auditing for Quality Assurance Course Description
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.
Perfect for professionals seeking to strengthen their auditing skills and contribute to maintaining high standards in pharmaceutical and healthcare industries
Training Agenda
GMP Auditing for Quality Assurance – 2-Day Course Agenda
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
Take the next step in mastering GMP auditing! This intensive 2-day training will equip you with the knowledge, tools, and confidence to ensure compliance and quality excellence.
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
Don't risk non-compliance—master GMP auditing today!
🚀 Enroll now to protect your business, ensure quality, and pass audits with confidence!
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
This live training seminar includes the following for each registered attendee:
- A copy of the presentation slides by download
- A certificate of participation for attendee training records
- Q/A Session
- Free Handouts on GMP Auditing
How to Attend:
All WCS Seminar live training programs audio and visuals are delivered via Go to Webinar with a basic system requirement of a computer with internet access. You do not require a Go to Webinar account to join WCS Seminars live training courses, participants receive an email invitation that provides the access you need to join the meeting.
Kelly Thomas (25+ year exp.)
Vice President, Americas Quality Operations at Stallergenes Greer - Charlotte Metro USA
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.
Over 20 years’ experience leading facility start-ups, PAI and Routine cGMP Surveillance inspections. Highly successful global regulatory and ISO compliance history with inspections including FDA, EMEA, IMB, JP, Health Canada, and ANVISA. Highly committed to implementing effective contract manufacturing, supplier management and Internal audit programs.
Strengths include developing staff, maintaining and developing budgets, implementing robust quality systems, communicating and implementing clear Key Performance Metrics (KPIs), conducting Quality Management Reviews and Executive Reports, implementing Lean Six Sigma programs, influencing and implementing positive change, and leading cross-functional teams.
