Effective Internal Audit Program
2-Day Seminar Completed | Recording and Pre-Registration Available
- Faculty: MEREDITH CRABTREE
- Product ID: SEM3112
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PRE-REGISTRATION AVAILABLE If you want to have this training scheduled Live and Exclusively for your company, we will arrange it for you. Pre-Register now and pay only once the training is scheduled on your preferred days.
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Join this 2-day seminar to master the creation and implementation of an efficient internal audit program. Internal audits are not just regulatory requirements; they are crucial for a robust Quality Management System (QMS) and a powerful tool for identifying areas of non-compliance. A well-structured audit program enhances understanding, communication, and mitigation of quality and compliance risks. Shockingly, up to 75% of companies conduct audits only to meet regulations, leading to ineffective outcomes and potential regulatory actions like FDA 483s, Warning Letters, or even Consent Decrees. This seminar transforms your audit approach into a proactive risk management tool, boosting awareness, identifying gaps, and reducing compliance risks. Learn to build a quality culture that values clear communication and continuous improvement.
WHY YOU SHOULD ATTEND: This seminar will revolutionize your internal audit process, transforming it from a regulatory burden into a strategic asset. Discover how to develop a meaningful audit structure that promotes proactive issue identification and resolution. Effective audits highlight QMS gaps, providing management with critical insights to prevent compliance issues and enhance product quality. Without a robust internal audit program, companies remain blind to potential risks, impacting compliance and customer satisfaction. Equip yourself with practical tools and techniques to create a transparent, efficient audit process supporting continuous improvement and regulatory compliance. Elevate your audit program and empower your team to drive quality and compliance excellence. | WHO SHOULD ATTEND:
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SEMINAR OBJECTIVES:
- Understand regulatory expectations for internal audits in the pharmaceutical and medical device industries, including ISO 13485 and FDA regulations.
- Develop and implement a streamlined, effective audit program for GMP (Good Manufacturing Practice) compliance.
- Identify and address common audit problems and red flags using root cause analysis.
- Utilize risk analysis techniques such as FMEA (Failure Modes and Effects Analysis) for a comprehensive audit strategy.
- Structure your audit program for maximum effectiveness and alignment with QMS (Quality Management System) standards.
- Master the auditing process, including preparation, conducting, interviewing techniques, and follow-up.
- Ensure thorough documentation and communication using industry best practices and compliance tools.
- Link audits to your quality system for sustained improvement and regulatory compliance.
- Train audit staff for proactive issue management, CAPA (Corrective and Preventive Actions), and continuous improvement.
- Foster a culture of quality and compliance to enhance audit effectiveness and regulatory adherence.
- Prioritize and implement corrective actions efficiently using CAPA methodologies.
- Monitor and communicate risk and improvement over time using key performance indicators (KPIs) and audit tracking systems.
- Identify residual and unnecessary compliance risks through comprehensive audit reviews.
- Provide management with valuable audit insights for strategic decision-making and risk mitigation.
- Manage corrective and preventive actions effectively to ensure continuous quality improvement and regulatory compliance.
AGENDA
DAY 1 (9 AM to 2 PM) Lecture 1: Overview and Regulatory Expectations
Lecture 2: Quality Systems Requirements
Lecture 3: The Audit Program
Lecture 4: Linkages in Your Quality System
Lecture 5: Auditor Qualifications and Skills
| DAY 2 (9 AM to 2 PM) Lecture 1: The Auditing Process
Lecture 2: Focus on Supplier Auditing
Lecture 3: Red Flags and Warning Signs
Lecture 4: Best Practices
Lecture 5: Interactive Discussion and Exercises
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Course Director: MEREDITH CRABTREE
 | Meredith Crabtree has over 30 years’ experience in regulated industries, ranging from Blood, Plasma, Tissue, Laboratory, Pharma, Medical Device, Cosmetics, Supplements, and Animal Health. This includes manufacturing, packaging, labelling and distribution operations. Meredith is the owner of MLKC Consulting is s a Quality Consultant specializing in product label reviews, 3rd party inspections, Consent Decree and Recall support. She also performs regulatory assessments and Quality trainings. |