Engineering

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)

 

                 EXAM APPLICATION DEADLINE
   
February 27 January 22, 2022
March 24 February 22, 2022
April 21 March 22, 2022
May 18 April 22, 2022
June 22 May 24, 2022
July 27 June 22, 2022
Aug 24 July 22, 2022
September 21 August 24, 2022
October 19 September 15, 2022
November  23 October 13, 2022
December 18 November 11, 2022

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