Online training Package ISO 22716 version 2007

Discover the ISO 22716 standard and

• its contents
• its principles
• its requirements
• its stakes

Get used to

• Good Manufacturing Practices for cosmetic products
• Cosmetic Regulation
• process approach
• cosmetic terminology
• applicable regulatory requirements
• risk management
• the specificities of cosmetic products

The important and fundamental elements of a medical device quality management system

• quality approach (quality management principles, PDCA cycle)
• standards
• process approach (definitions, process types, mapping)
• personnel hygiene
• premises and requirements
• equipment
• raw materials
• production
• finished products
• laboratory
• nonconforming products
• subcontracting
• internal audit
• documentation
• placing on the market

The menu of the course

• Presentation
• MCT (multiple-choice test) Beginning (10 questions)
• 1 Good Manufacturing Practices (GMP)
  • 1.1 History
  • 1.2 Benefits
  • 1.3 Application
  • 1.4 Standards, definitions, books
  • 1.5 Principles and steps
• MCT GMP (7 questions)
• 2 Process approach
  • 2.1 Processes
  • 2.2 Mapping
  • 2.3 Approach
• MCT Process approach (6 questions)
• 3 Personnel
  
  • 3.1 Principle
  • 3.2 Organization
  • 3.3 responsibilities
  • 3.4 Training
  • 3.5 Hygiene
  • 3.6 Visitors
• Case Clean room
• Summary of clause 3
• MCT Personnel (6 questions)
• 4 Premises
  • 4.1 Principle
  • 4.2 Areas
  • 4.3 Space
  • 4.4 Flow
  • 4.5 Floors
  • 4.6 Toilet facilities
  • 4.7 Lighting
  • 4.8 ventilation
  • 4.9 Pipework
  • 4.10 Cleaning
  • 4.11 Maintenance
  • 4.12 Consumables
  • 4.13 Pest control
• Summary of clause 4
• MCT Premises (6 questions)
• 5 Equipment
  • 5.1 Principle
  • 5.2 Design
  • 5.3 Installation
  • 5.4 Calibration
  • 5.5 Cleaning
  • 5.6 Maintenance
  • 5.7 Consumables
  • 5.8 Authorizations
  • 5.9 back-up
• Summary of clause 5
• MCT Equipment (6 questions)
• 6 Raw materials
  • 6.1 Principle
  • 6.2 Purchasing
  • 6.3 Receipt
  • 6.4 Identification
  • 6.5 release
  • 6.6 Storage
  • 6.7 Re-evaluation
  • 6.8 Water
• Case Selecting suppliers
• Summary of clause 6
• MCT Materials (6 questions)
• 7 Production
  • 7.1 Principle
  • 7.2 Manufacturing
  • 7.3 Packaging
• Case Task priority
• Case Process stability
• Case New line
• Case Change
• Summary of clause 7
• MCT Production (6 questions)
• 8 Finished products
  • 8.1 Principle
  • 8.2 release
  • 8.3 Storage
  • 8.4 Shipment
  • 8.5 Returns
• Summary of clause 8
• MCT Finished products (6 questions)
• 9 Laboratory
  • 9.1 Principle
  • 9.2 Test
  • 9.3 Criteria
  • 9.4 Results
  • 9.5 Out-of-specification
  • 9.6 Reagents
  • 9.7 Sampling
  • 9.8 Retain sample
• Summary of clause 9
• MCT Laboratory (6 questions)
• 10 Nonconforming products
  • 10.1 Rejected products
  • 10.2 Reprocessed products
• Case Communication
• Case Nonconformities
• Case Kaizen & problem
• Summary of clause 10
• 11 Wastes
  • 11.1 Principle
  • 11.2 Types of waste
  • 11.3 Flow
  • 11.4 Containers
  • 11.5 Disposal
• Case Customer and need
• Summary of clause 11
• MCT Nonconformities (6 questions)
• 12 Subcontracting
  • 12.1 Principle
  • 12.2 types
  • 12.3 Contract giver
  • 12.4 Contract acceptor
  • 12.5 Contract
• Summary of clause 12
• MCT Subcontracting (6 questions)
• 13 Deviations
• Summary of clause 13
• 14 Complaints and recalls
  • 14.1 Principle
  • 14.2 Complaints
  • 14.3 Recalls
• Summary of clause 14
• 15 Change controls
• Summary of clause 15
• 16 Internal audit
  • 16.1 Principle
  • 16.2 Approach
  • 16.3 Follow-up
• Case Audit readiness
• Case Audit program
• Case Auditor question
• Case Audit report
• Summary of clause 16
• MCT Audit (6 questions)
• 17 Documentation
  • 17.1 Principle
  • 17.2 Types
  • 17.3 Writing
  • 17.4 revision
  • 17.5 Archiving
• Summary of clause 17
• MCT Documentation (6 questions)
• 18 Placing on the market
  • 18.1 Cosmetic Regulation
  • 18.2 Before placing on the market
  • 18.3 After placing on the market
• MCT End (20 questions)