Charisma

#	Content
1	Module 1: Introduction to Aberrant Laboratory Results
2	Module 2: Classification of Aberrant Results
3	Module 3: Laboratory Investigation Process
4	Module 4: Root Cause Analysis
5	Module 5: Corrective and Preventive Actions (CAPA)
6	Module 6: Regulatory Compliance and Documentation
7	Module 7: Practical Applications
8	Module 8: Case Studies and Exercises

#	Outcomes
	• Define aberrant laboratory results and distinguish between OOS, OOT, and atypical results.
	• Conduct laboratory investigations using risk-based and scientific approaches.
	• Evaluate potential laboratory and manufacturing-related causes of aberrant results.
	• Perform root cause analyses and recommend appropriate CAPA measures.
	• Document investigation findings in accordance with GMP requirements.
	• Assess the impact of aberrant results on product quality and regulatory compliance.
	• Apply best practices to improve laboratory performance and data integrity.

#	Participants
1	� • Quality Assurance (QA) professionals.
2	� • Quality Control (QC) analysts and supervisors.
3	� • Microbiology laboratory personnel.
4	� • Regulatory Affairs specialists.
5	� • Manufacturing and Production staff.
6	� • Validation and Compliance professionals.
7	� • Laboratory managers and supervisors.
8	� • Pharmaceutical industry professionals involved in laboratory investigations and quality management.