Cognicert Pharmaceutical GMP Professional

• Members of a Quality team
• Professionals wanting to gain a comprehensive knowledge of the main processes of a Pharmaceutical Good Manufacturing Practices (PGMP)
• Staff involved in the implementation of the PGMP
• Staff involved in operations related to a PGMP
• Auditors

• To Understand the implementation of a Pharmaceutical Good Manufacturing Practice
• To Understand the relationship between a Pharmaceutical Good Manufacturing Practice and compliance with the requirements of different stakeholders of the organization
• To Know the concepts, approaches, standards, methods and techniques allowing to effectively manage a Pharmaceutical Good Manufacturing Practice
• To acquire the necessary knowledge to contribute in implementing a Pharmaceutical Good Manufacturing Practices (PGMP).

• What are the GMPs
• Intro to the FDA
• Intro to the FD & C

• EU and other regulations
• Importance to our manufacturing

• Department Roles/Functions
• Interactions
• Training
• Change Control

• Types of Facilities – Solid Dose, Aseptic, Biologic, API
• Facilities and Equipment – the role they play
• Flows – Material, Air, Personnel
• Lighting, Plumbing, & Containment/Contamination

• Classification of materials according to function
• Material specifications
• Vendor Auditing - qualifying, and controlling suppliers and contractors
• Control of incoming materials
• Container Closure and other GMP functions
• What the regulations require for reduced testing

• The Validation Master Plan
• Review and Approval of Master Records
• Converting the Master Record to a Batch or History Record
• Predicate rules and Part 11 – What are they really
• Another new paradigm-Process Analytical Technology (PAT)

• Why is packaging and labeling is so important?
• Controlling Labels and other Printed Materials
• Examining and storing Packaging & Labeling Materials
• Controlling labeling operations

• Qualification v. Validation
• Protocol Development
• Types of Validation
• Executions
• Final Reports

• Sampling
• Analytical methods-Scientific Basis, Approval, & Validation
• Pharmacopeias
• Methods Validation Requirements
• Equipment Qualification Requirements
• Controlling Reagents & Reference Standards
• Laboratory Data-Notebooks, LIMS, & Disks
• Equipment Controls
• Using a Contract Laboratory

• QA Responsibilities in Product Release
• Why perform testing on finished products?
• Batch Record Review
• Recalls

• Storing Documents and Retains
• When Things Go Wrong
• Getting to the Root Cause

• 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

• Build a clear working understanding of Pharmaceutical GMP Professional.
• Apply relevant principles, requirements and good practice in realistic organisational contexts.
• Prepare participants to contribute confidently to implementation, assurance or professional practice.

By the end of the programme, participants should be able to explain the core concepts, identify practical requirements, evaluate evidence and plan appropriate improvement actions.

The programme draws on recognised international standards, professional guidance and current good practice relevant to Pharmaceutical GMP Professional.

Suitable for managers, practitioners, auditors, implementers, consultants and other professionals whose responsibilities relate to Pharmaceutical GMP Professional.

• Stronger practical capability and professional confidence
• A structured approach that can be transferred to the workplace
• Assessment and a verifiable Cognicert certificate where the course requirements are met

The programme covers essential concepts, requirements, implementation considerations, evidence-based evaluation, common challenges and practical improvement planning.

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

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