• What is GMP?
• The history behind GMP
• Why is there a need for GMP?
• Quality assurance links to GLP, GCP, GDP, and GAMP®
• GMP and its link with Quality Assurance and Quality Control
• The importance of the quality unit
• Change control and its impact
• The new focus of applying risk assessment
• What are the relevant regulations?
• The Orange Guide and European Directives
• Change control and its impact
• The Code of Federal Regulations
• Who the regulatory agencies are, how they audit and enforce the regulations, including legal requirements
• MHRA
• FDA
• Types of audit including the FDA systems approach
• Internal audits
• Current hot topics in the regulatory world
• Investigate the 4 Ps:  People; Procedures and documentation; Production areas and equipment; Products and components 
• People - Adequacy, experience, training and the role of the Qualified / Responsible Person
• Organisational structure and adequacy
• The importance of training, experience and qualification as viewed by the regulators
• Personal hygiene requirements
• Procedures and documentation - from the completion of SOPs to in-process controls
• Document control
• Sufficient and efficient use of SOPs
• Packaging instructions, batch manufacturing records, in-process controls and associated documents
• Warehouse and logistics; status labelling, and FIFO
• Associated errors with documentation
• Production areas and equipment - premises, layouts and considerations
• The importance of cleanliness; clean rooms, sterile operations and gowning operations (including links to micro-biological and cross contamination)
• An overview of basic microbiology and GMP
• Layout of facilities and equipment
• Packaging and manufacturing equipment; design, validation, line clearance, components and materials, label control and reconciliation
• Products and components
• Incoming, handling, storage, packaging, labelling and non-conforming products
• Threat of mix-up and contamination
• Importance of change control and purchasing
• Printing on packaging
• Product security attention through on-line controls
• Process validation and change control; life cycle concepts
• Understand good documentation practices
• Basic terms and definitions relating to manufacturing and packaging operations
• Types of documents; records and instructions
• Legal requirements; retention period and completion
• Lifecycle of an SOP
• Regulatory requirements
• How to complete a document correctly
• Electronic records and signatures and 21 CFR Part 11
• The importance of Standard Operating Procedures (SOPs)
• Managing SOPs effectively
• Everyday use of SOPs
• What makes a good SOP?
• Training requirements and best practices
• Explore errors in documentation using examples and case studies
• Common everyday occurrences which affect businesses and customers
• SOP problems
• Common highlighted FDA warning examples
• Investigate why healthcare manufacturing companies have to carry out validation
• History of validation and links to GMP
• What is validation and its purpose?
• Understand the key stages of the validation model, terminology, and processes for new and other projects
• What is GAMP®?
• The principles of validation
• European and USA regulations and validation, including 21 CFR Part 11 and Annex 11 and 14 (EU GMP Guidance)
• What can go wrong in companies?
• Solve problems for GMP improvements
• Understand creative thinking techniques
• Select and apply problem solving techniques to a real scenario
• Apply previous course learning to
• Identify potential GMP violations and their consequences
• Use interactive video case studies of real events in manufacturing plants
• Team activities, analysing problems and identifying solutions
• Review of recorded real events; FDA warning letters and latest topics
• Use interactive case studies to analyse scenarios
• Reflect that people are the biggest threat to GMP
• Examine real reported incidents
• Determine behaviours that improve GMP
• Relate to real work activities
• Plan for workplace improvements
• Action plan for applying learning

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