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- Email : info@mctimothyassociates.com
Why Attend
Course Objectives
• To review general requirements for documents
• To review specific requirements for each document
• To consider current issues applicable to your organisation
• To identify the role of self-inspection in the quality management system
• To review the way in which a self-inspection programme should be carried out
• To discuss what to inspect and verify in a company’s self-inspection system
• Discuss aspects of good practices in production
• Discuss aspects of good practices in quality control
• Group session
Event Date: –
Course Objectives
• To review general requirements for documents
• To review specific requirements for each document
• To consider current issues applicable to your organisation
• To identify the role of self-inspection in the quality management system
• To review the way in which a self-inspection programme should be carried out
• To discuss what to inspect and verify in a company’s self-inspection system
• Discuss aspects of good practices in production
• Discuss aspects of good practices in quality control
• Group session
Course Content
• Introduction to the GMP
• Quality Management
o Sanitation and hygiene
o Qualification and Validation
o Complaints and recalls
o Contract production and analysis
o Self-inspection and Quality Audits
o Personnel
o Premises
o Equipment
o Materials
o Documentation
o Good Practices in Production and Quality Control
o Quality Assurance and Quality Control
• GMP Inspection CAPA Process
o Introduction
o The role of the inspector
o Preparation for an inspection
o Types of GMP inspection
o The inspection
• Continuous Improvement
o CAPA Overview
o Conducting Effective Investigations and Root Cause Analysis
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