By the end of this course, participants will:

• Gain an in-depth understanding of GLP regulations and compliance.
• Learn advanced techniques for laboratory quality assurance and data integrity.
• Develop strategies for handling audits and inspections.
• Enhance proficiency in laboratory documentation and record-keeping.
• Implement risk management practices in GLP environments.

This course is ideal for:

• Laboratory managers and supervisors
• Quality assurance (QA) and compliance professionals
• Scientists and research analysts
• Regulatory affairs personnel
• Anyone responsible for GLP compliance in research and testing laboratories

Day 1: Fundamentals & Advanced Principles of GLP

• Overview of GLP and its significance in regulated industries
• International GLP regulations (OECD, FDA, WHO, EPA, EMA)
• Responsibilities of laboratory personnel under GLP
• Common challenges in maintaining GLP compliance
• Case study: Real-world GLP violations and corrective actions

Day 2: Laboratory Quality Systems & Data Integrity

• Establishing and maintaining an effective quality system
• Ensuring data integrity: ALCOA+ principles
• Good documentation practices (GDP) and record management
• Electronic data management and compliance (21 CFR Part 11)
• Workshop: Identifying data integrity risks and solutions

Day 3: Equipment, Facilities & Method Validation

• GLP-compliant laboratory facility design and maintenance
• Calibration, validation, and qualification of laboratory equipment
• Method validation: Accuracy, precision, specificity, and robustness
• Handling deviations, non-conformities, and out-of-specification (OOS) results
• Workshop: Developing a validation protocol

Day 4: Audits, Inspections & Risk Management in GLP

• Preparing for internal and external audits (FDA, OECD, EPA inspections)
• Common GLP audit findings and remediation strategies
• Implementing risk-based approaches to GLP compliance
• Corrective and preventive action (CAPA) planning
• Case study: Successful GLP audit case analysis

Day 5: GLP Best Practices & Continuous Improvement

• GLP training and competency development for laboratory staff
• Ethics and regulatory expectations in laboratory research
• Emerging trends in laboratory automation and compliance technology
• Developing a roadmap for GLP excellence in laboratories
• Final review, Q&A, and certification

CDGA attendance certificate will be issued to all attendees completing minimum of 80% of the total course duration