GMP Training

• What is Current Good Manufacturing Practice and how this impacts product quality and food safety
• Understand the elements of Current Good Manufacturing Practice cGMP
  • Personal Hygiene
  • Critical Redline Procedures
  • Pathogen Management
  • Illness Management including Covid 19 and Norovirus
  • Standard Operating Procedures SOPs
  • Statistical Process Control SPC
    • Six Sigma Introduction
  • Problem-solving and Root Cause Analysis
  • Integrated Pest Management
  • Cleaning and Sanitizing
  • Microbiological Controls
  • HACCP Risk Knowledge
• How to target and improve risk knowledge around cGMP and HACCP
• Check-list for improving audit scores

Additional add-on technological options for dairy companies include:

• Alkaline phosphatase testing guidance
• Collection of milk not intended for supply
• Risk organism preparedness and response
• Maintenance compounds procedure for approval
• Criteria relating to factory water
• Managing dairy material or products potentially exposed to chemical residues
• Guideline for RMP manufacturers of colostrum products
• Labeling requirements for retail & exports of dairy-based infant formula products and formulated supplementary food for young children

• History of GMP and why we need regulations and guidelines.
• Current GMP – FSMA 2015
• Terms such as quality systems, quality control (QC), quality assurance (QA), self-inspection, documentation, problems (e.g. mix-ups, cross-contamination), complaints, recalls, deviations, etc.
• Basic principles of GMP and the challenges within them.
• Pharmaceutical Chain which contains Raw Materials, API (Active Pharmaceutical Ingredient), Excipients, Formulation, Packaging, QC-testing, Release, and Distribution.
• Terms ICH (International Council for Harmonisation), IMP, GCP (Good Clinical Practise), GDP, QTPP (Quality Target Product Profile), CQA (Critical Quality Attribute).
• GMP quality systems (Deviations, Change Control, Out of Specifications (OOS)).
• CAPA (Corrective Action Preventive Action), KPI (Key Performance Indicators).
• Quality Risk Management and terms such as FMEA (Failure Mode Effect Analysis).
• Documentation – hierarchy, batch records, document attributes, revisions.
• SOP (Standard Operating Procedure), batch production records, and certificates.
• Infrastructure, Air Locks, Pressure Cascade, HVAC (Heating Ventilation, and Air Conditioning), Laminar Air Flow (LAF).
• Line Clearance, Cleaning and Disinfection.
• Aseptic handling.
• Deviations and OOS. Root cause analysis, Impact assessment, CAPA, and KPI.
• Case study regarding deviations and root cause analysis.
• Change control, how it differs from the deviation, and how to make an action plan.
• Material Flow.
• The different types of incoming goods and risk assessment in material management.
• Labeling & packaging (primary, secondary), the related guidelines, reconciliation, blinding, randomization.
• Equipment qualification, V-model, User Requirement Specification (URS), IQ, OQ, PQ (Installation, Operational or Performance Qualifications), risk assessment, FMEA, validations in USP, DSP, line clearance, cleaning process (CPP).
• Development, life cycle, and validation of an analytical method, the difference between validation and qualification.
• Testing parenteral (e.g. sterility, bioburden, endotoxin, mycoplasma)
• What to do in case of “Out of Specifications (OOS)” (e.g. lab investigation, root cause analysis, reporting, instability, recall).