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Training Courses

> ISO22000
> ISO17025
> ISO13485
> GMP
> GWP
> VALIDATION
> QUALITY AWARENESS

ISO22000

3 or 5 days
Includes 1.5 day internal auditing
Food safety & Regulations

  • 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
Good Laboratory Practices (GLP)

  • 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
Management system & Medical device

  • 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
Quality, QC and QA

  •  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
Quality, QC and QA

  •  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
    • IQ,OQ & PQ
  • 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
Quality Awareness

  • 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

NEXT course:

 

BOOK ASAP ISO 13485 MEDICAL DEVICE REGULATORY COURSE LIMITED ATTENDANCE
,
JHB (Johannesburg).
CTN COURSE dates To follow - email info@r-sctraining.co.za to pre-book - Click here to APPLY

 

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Quick contact

Tel: +27 31 563 3271
Cell: +27 82 871 5740
Email: shortt@gns.co.za

 

 

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