Live GMP Auditing Seminar Offers Compliance Insights For Pharma & Med Device Pros (ONLINE EVENT: April 23-24, 2025)

(MENAFN- GlobeNewsWire - Nasdaq) Tailored for pharmaceutical and medical device professionals, this live seminar equips attendees with essential skills to conduct internal and vendor GMP audits in line with USFDA and ICH Q10 standards. Participants will learn to use audit trails and checklists, evaluate findings, and enhance their understanding of cGMP compliance. Led by industry expert Kelly Thomas, the course includes downloadable slides, Q&A, worksheets, and a participation certificate. Ideal for QA/QC specialists, auditors, engineers, and regulatory professionals aiming to strengthen audit capabilities and ensure compliance excellence.

Dublin, April 01, 2025 (GLOBE NEWSWIRE) -- The "GMP Auditing for Quality Assurance: Online Training for Compliance & Regulatory Readiness (ONLINE EVENT: April 23-24, 2025)" 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.

The 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

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

Who Should Attend:

• This course is recommended for individuals with two to three years of direct experience working with the USFDA and PIC/S GMP guidelines who want to develop additional expertise in GMP Auditing
• New auditors or individuals wanting to become auditors
• Professionals who are responsible for conducting internal or vendor GMP audits
• Suppliers and others who are audited, such as quality assurance and quality control specialists, validation scientists, manufacturing supervisors, technical support personnel, engineers, and all levels of management

Course Agenda:

Auditing Department Basics

• Exercise: Be, Know, Do

Traits/Skills of a Good Auditor

• Group discussion: Fishbone Diagram
• Group discussion: Exercise: Potential Interview Problems
• Group work: Exercise: Getting it Right

GMP Background Information for Auditors

• Exercise: Home Base Worksheet
• Exercise: Preamble Activity

Pre-Audit Information

Conducting the Audit

• Group work: Common Items to look for in an Audit

Post Audit

• Group work: Classifying, Managing, Justifying your findings
• Exercise: cGMP Compliance
• Exercise: Ranking - GMP Observations
• Group work: Root Cause Analysis 5 Why's
• Group work: Root Cause Analysis From Fishbone

Additional Resources and Worksheets/Checklists

• Calibration, Equipment and Validation Information
• Audit Strategies
• Additional Considerations for GMP Auditing
• Audit Report Examples

For more information about this training visit

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