> ISO22000
> ISO17025
> ISO13485
> GMP
> GWP
> VALIDATION
> QUALITY AWARENESS
ISO22000
3 or 5 days
Includes 1.5 day internal auditing
- Overview of Food safety & Regulations
- Regulation 918 & 908 27 , Codex Alimentarius Commission, Labelling of foodstuffs
- Introduction to Risk / Hazard management Process & Control
- SANS 10330, ISO9001 & ISO22000 Overview
- HACCP study – 7 principles
- OVERVIEW OF ISO22000 FOOD SAFETY MANAGEMENT STANDARD
- Food Safety Management System (FSMS) Documentation & Records
- Overview of Prerequisite programmes
- Planning and realisation of SAFE products
- Food Standards Programme Codex Alimentarius Commission’s general requirements
- SANS 10049 (SABS 049: 2001), PAS 220
- Operational pre-requisite programs (OPRPs)
- Continual improvement
- Food Hazards: Microbiology, Allergens, Toxicity
- Exposure to the international ISO2000 standard to ensure all the elements are addressed for certification purposes and ensure the companies good food safety corporate governance
- Enlighten the delegates to the conditions and types of document control
- Experience with the auditing concepts and practical coverage of the auditing process for the planning, preparation, practice, reporting and follow up
|
ISO17025
3 days
Includes 1.5 day internal auditing
- Introduction to Good Laboratory Practices (GLP)
- OVERVIEW OF ISO17025 General requirements for the competence of testing and calibration laboratories
- Organization, Management System, Management Review, Document & Record Control, Contracts & Services, Complaints, non-conformance handling and Corrective and Preventive Action
- Technical Requirements; Personnel, Accommodations and Environmental Conditions, Test and Calibration Methods and Method Validation, Equipment, Measurement Traceability, Sampling, Handling and Transportation of Test and/or Calibration Items, Assuring the Quality of Test and Calibration Results and Reporting the Results
- Outline of documentation requirements, benefits and outline the typical documentation structure
- Document control
- Experience with the auditing concepts and practical coverage of the auditing process for the planning, preparation, practice, reporting and follow up
|
ISO13485
5 days
Includes 1.5 day internal auditing
- Introduction to ISO 13485 management system
- Definitions of a medical device
- Role Players and Legislation
- ISO 13485 Management System review
- Organization, Management System, Management Review, Document & Record Control, Contracts & Services, Complaints, non-conformance handling and Corrective and Preventive Action
- Processes & Quality
- ISO9001 vs 13485
- GMP, CAPA & Continual improvement
- ISO14971 Risk Management system
- Risk analysis, 5 Risk evaluation, 6 Risk control
- Overall residual risk evaluation
- Risk management report
- Post-production information
- Experience with the auditing concepts and practical coverage of the auditing process for the planning, preparation, practice, reporting and follow up
|
GMP (GOOD MANUFACTURING PRACTICES)
1 day
- GMP Principles
- Quality, QC and QA
- Process definition
- Good document management system, principles of documentation
- General requirements of GMP
- Management & Supervision
- Production
- Premises & Equipment
- Personal Hygiene & Health
- Control of Operation
- Maintenance & Sanitation
- Transport
- Product information
- Training
- Cleanroom & HVAC
|
GWP (GOOD WHOLESALE / WAREHOUSE PRACTICES)
1 day
- GWP Principles
- Quality, QC and QA
- General requirements of GWP
- Principles of documentation
- Control of Operation
- Pick & Pack
- Good HOUsekeeping practices
- Cold chain management
- Personal Hygiene & Health
- Strorage & Transport
- Training
- Self Inspection
|
VALIDATION
2 days
- Validation & Verification
- Process Capability
- Equipment Validation definitions & approach
- Test Method Validation
- Accuracy, Precision, Specificity, Limit of detection, Limit of quantitation, Linearity and range, Ruggedness
- FDA , ICH & PIC GMP
- Strategy & Methodology of Analytical validation
- Validation Report
- Cleaning Validation
|
QUALITY AWARENESS (Shopfloor, Basic)
1/2 day
- What is & Why Quality
- How do I do and where is Quality
- How do I measure Quality
- Concept of Quality Management, QA & QC
- Concept of Cost of Quality
- Positive and Negative Results of Quality
|
