• Process Flow Diagram (PFD)
• Controlling Air Quality
• Heating, Ventilation, and Air Conditioning (HVAC) Systems
• Biopharmaceutical Unit Operations – Drug Substance
• Biopharmaceutical Unit Operations – Drug Product
• Pharmacopeia Grade Waters
• Process Support and Utilities
• Introduction to ISO 9001:2008
• Typical GMP list for drug substance
• Operational Activities
• GMP for Personnel
• Quality Systems Approach to Pharmaceutical cGMP Regulations – The Quality Systems Model
• Maintenance: Good and Best Practices

• Finished Medicinal Products
• Introduction to Quality Risk Management (QRM)
• Risk Management Tools – Fault Tree Analysis (FTA)
• Clinical Trials
• Focus on Patient Safety and Product Quality
• Process Validation

• ISPE Baseline Guide 5 – Commissioning & Qualification Practices
• Risk Management Tools – Cause and Effect Diagram
• ISO 9001:2008 ‘Quality Management Systems – Requirements’
• Good Engineering Practices (GEP)
• ASTM E 2500– 07 Standard Guide for Specification, Design, and Verification of Equipment

• GAMP5 – Software Categories & Scalable Validation Deliverables
• GAMP5 – Operation Activities
• Risk Management Tools – Failure Mode, Effects (and Criticality) Analysis (FMEA / FMEAC)
• GAMP5 – Risk-Based Decision Making
• Product Quality and Current Good Manufacturing Practices (cGMP)

• Chemical Reactions
• Separation Technologies
• Batch Organic Chemical Synthesis
• Risk Management Tools – Preliminary Hazard Analysis (PHA)
• Multi-Stage Sequence API Synthesis
• Regulatory guidelines for synthetic API Manufacturing
• Relationship Between BPC and API

• Biopharmaceuticals Manufacturing, Upstream, Fermentation
• Cellular Protein Synthesis
• Risk Management Tools – Hazard Operability Analysis (HAZOP) –TC
• Biopharmaceuticals Manufacturing – Downstream Processing – Column Chromatography
• Biopharmaceuticals Manufacturing: Special Considerations

• Engineering Aspects of Cleaning, and Cleaning Equipment
• Chemistry Aspects of Cleaning
• Risk Management Tools – Event Tree Analysis (ETA)
• Cleaning Validation
• ISO-9001 ‘Continual Improvement’ & ICH Q10 Pharmaceutical Quality System

• Tablet Manufacturing
• Vial Filling & Freeze Drying
• FDA Medical Device Rules
• Risk Management Tools – Hazard Analysis and Critical Control Points (HACCP)
• Medical Devices – EU Classification
• Aseptic & Sterile Manufacturing
• Medical Device Regulations and Guidelines

• PQ, OQ IQ
• Documenting the Quality Risk Management Process
• Product Realization & Pharmaceutical Development

Write a paper on “Why cGMPs are required for the manufacture of a life sciences product”.

You will receive an end of course certificate from GetReskilled which along with others modules can build into an academic accreditation from the Dublin Institute of Technology (Ireland) subject to the following criteria;

• Passing a written or oral exam on the materials.
• The submission of all assessments and the end of module assignment.