Cognicert GMP Professional

Cognicert Good Manufacturing Practices (GMP) Professional Course

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

• PGMP Assessment Fundamentals
• Principles of audit and Challenges of PGMP Assessment
• Internal Assessments
• Management Reviews
• Stages of external Assessments
• Creating a Corrective Action Plan
• The Root Cause Analysis Process
• Corrective and Preventive Actions
• External audit follow –up
• Continuous Improvement

Duration: 5 days

Training Methodologies

• Case Study
• Individual Exercises
• Role Play
• Group Exercises
• Group Presentation
• Examination

Assessment and Qualification
Learning is assessed through:

• 4 hours open examination. Passing the exams qualifies the candidate for Cognicert GMP Professional (CPD Certificate)
• Practical experience of 25 days with activity log qualifies participants for our Cognicert GMP Professional (Implementer Category) I.D Card and Certificate
• Practical experience of 50 days with activity log qualifies participants for Cognicert GMP Professional (Lead Implementer Category) I.D Card and Certificate

Self-Study Material, Exam and Certification 

Online Training, Material, Exam and Certification 

Classroom Training Location Here (Fee to be decided by delivery partners)

Cancellation: 3 weeks before examination attract 100% refund. 0% refund after.