• 2.1 Introduction to ISO 9001:2008 and ISO9001:2015
  This lesson is about the key requirements of a quality management system.
• 2.2 Typical GMP list for drug substance
  This lesson explores the content of ICH Q7 “Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients”.
• 2.3 Operational Activities
  In this lesson, we take a look at how to maintain a critical computerized system in a state of operational control using standard procedures.
• 2.4 GMP for Personnel
• 2.5 Quality Systems Approach to Pharmaceutical cGMP Regulations – The Quality Systems Mode
  In this lesson, we describe a quality system model in accordance with management responsibilities, resources, manufacturing operations and evaluation activities.
• 2.6 Maintenance: Good and Best Practices
  In this lesson, we describe basic and good practices associated with maintenance in a regulated environment.

• 3.1 Project Lifecycle for New and Modified Facilities
  In this lesson, we describe the typical phases of a project lifecycle: conceptual design, tender contract analysis, basic engineering, detailed design, and project realization.
• 3.2 Plant Layout
  In this lesson, we explore the vertical distribution of process equipment for a bulk process building, the horizontal layout for a bulk process building, and an entire site layout for an integrated biopharmaceutical manufacturing site.
• 3.3 Zoned Air-Conditioning Systems
  In this lesson, we look at a practical example where a HVAC system can be dynamically operated to control the temperature of a room (space
• 3.4 Isolator Technology
  In this lesson, we explain the principles behind the use of ‘isolators’ and Restricted Access Barrier Systems (RABs) for critical ‘open processing’ operation.
• 3.5 Cell Breakage
  In this lesson, we describe a mechanism for bacterial cell disruption for the recovery of intracellular products.

• 4.1 Purified Water (PUW) Generation, Storage and Distribution
  In these lessons, we look at methodologies to generate, store and distribute pharmacopeia grade purified water (PUW).
• 4.2 Clean Room and Clean Air Device monitoring 
• 4.3 Good Engineering Practices Procedures
  In this lesson, we will develop an understanding of good engineering practices, and learn about some various organizations that produce them.
• 4.4 GMPs for Buildings and Facilities 
• 4.5 Quality Systems Approach to cGMP Regulations – Management Responsibilities
  In this lesson, we outline management’s role in the design, implementation, and management of the quality system.
• 4.6 Maintenance Program
  In this lesson, we describe the key aspects of a typical maintenance program.

• 5.1 Conceptual Design – Part-1
  In this lesson, we begin to explore a quantified effort in how to size, shape, program, and cost an investment.
• 5.2 HVAC Requirements for Non-Sterile API Manufacturing
  In this lesson, we look at how to use airflow direction as a means of a containment barrier between operational areas in a non-sterile multi-product active pharmaceutical ingredient (API) manufacturing facility.
• 5.3 Plant Automation
  This lesson is an introduction to conventional process control using one-way digital and analogue signals.
• 5.4 Plant Steam
  In this lesson, we describe a process for generating and distributing plant steam to various processes within a manufacturing facility, and also describe how to manage any resultant condensate.
• 5.5 Clean Steam Generators
  The objective of this lesson is to demonstrate how we produce clean steam using ‘Single-Effect Distillation’ ‘Multiple-Effect Distillation. 
• 5.6 Steam Sterilization in Place
  In these lessons, we look at the mechanism behind sterilization of process equipment using saturated steam.
• 5.7 GMPs for Process Equipment 
• 5.8 Quality Systems – Resources
  In this lesson, we describe what resources need to be allocated for a quality system and operational activities.

• 6.1 Conceptual Design – Part-2
  This lesson describes what influences the layout of a facility in terms of: Layers, Preliminary Layout, Process Layouts, Media and Buffer Preparation, Clean Utilities and CIP, Access Corridors, Warehouse / Material Movements, Personnel Movements, Decisions on Height, Air Handling, General Utilities, Electrical, Controls & Automation, Finishes, Structural / Civil, Cost Estimate, and Schedule.
• 6.2 Air Flow Patterns 
  In these lessons, we look at laminar air-flow patterns in the context of filling open vessels aseptically, and at the configuration and operation of both a laminar flow booth and a laminar flow cabinet typically found in the biopharmaceutical industry.
• 6.3 Cleanroom Layout 
  In this lesson, we take a high-level look at a common cleanroom configuration and discuss items such as airflow direction, filter arrangements, cleanroom garments, and personnel and material flows. Another objective of this lesson is to also gain an understanding of personnel and material flows in a controlled airflow environment designed to contain high potency chemicals. 
• 6.4 Filter Ratings
  In these lessons, we look at the particle retention efficiencies of air filters of various grades rated in accordance with European normalisation standards EN779 and EN1822. We also look at the particle arrestance efficiency of air filters of various grades rated in accordance with the ASHRAE standard 52-2 ‘Minimum Efficiency Reporting Value (MERV Rating)’.
• 6.5 Logic Gates Functions and PLC 
• 6.6 WFI Storage and Distribution
  In this lesson, we take a look at a process for the storage and distribution of pharmacopeia grade water for injection (WFI) and how to maintain its specification.
• 6.7 Good Engineering Practices Procedures
• 6.8 Quality systems Approach- Manufacturing
  In this lesson we describe Manufacturing’s responsibilities for (a) designing, developing, and documenting product and processes, (b) examining inputs, (c) performing and monitoring operations, and (d) addressing nonconformities.
• 6.9 Maintenance- Work Executions
  In this lesson we describe the following Maintenance tasks and activities: (a) work request, (b) work order management, (c) information requirements for work orders, and (d) performance measurement.

• 7.1 Site Master Planning – Part-I
  In this lesson, we take our first look at site master planning based on: planning rationale, assumptions, prerequisites, typical bulk production unit, site scope, flexibility, expandability, & future-proofing, determining size requirements, sizing & shaping, and broad rules.
• 7.2 Classification of Clean Areas – Vial Filling 
  In these lessons, we look at: (1) how to classify areas for aseptic operations, (2) typical configurations of air handling units (AHU’s), terminal filters, zone air-inlets and -exhausts to support various classified environments, (3) filter arrangements in air handling units and in their supply air ducting, (4) particles limits associated with various classified air environments, and (5) viable microbial limits, measured as Colony Forming Units (CFU), associated with various classified air environments.
• 7.3 Area Classification Protection
  In this lesson, we observe a range of airlock configurations typically used in combination under operational conditions to maintain the specification of critical environmental zones, such as those used in open processing, that have a major impact on product quality and patient. 
• 7.4 Compress Air and Pneumatics 
• 7.5 Aseptic Filling
  In this lesson, we describe the process equipment for the filling of medicinal vials aseptically in the sequence of: washing, dehydrogenation, filling and their subsequent inspection.
• 7.6 Cleanroom Gowning
  In this lesson, we describe clothing that will minimize dispersion from skin and clothing for personnel working within a cleanroom environment.
• 7.7 Aseptic Processing 
  In these lessons, we look at various manual and automated processes and facility layouts for vial filling operations.
• 7.8 Cleanroom Monitoring – Physical Tests
  In this lesson, we discuss typical physical tests to monitor cleanroom environments: non-viable particle counts, pressure differentials, airflow velocity, air change rate, and filter integrity testing.
• 7.9 Quality System – Evaluation Activities 
• 7.10 Maintenance Management
  This lesson describes the processes and controls used in the delivery of maintenance services and work execution.

• 8.1 Site Master Planning – Part-II
  We continue in this lesson exploring the configuration philosophy for a site specifically layering configuration options, fermentation/bioreactor, media and buffer preparation. We also look at the shaping and sizing options for fermentation, media preparation, buffer preparation, downstream processing, process and general utilities, buildings, and expansion.
• 8.2 Open Versus Closed Processing  
• 8.3 Facility Layout Concept 
• 8.4 Blow/Fill/Seal Technology 
• 8.5 PLC Programming
  In this lesson, we describe how to program a PLC to automate a machine using ladder logic diagrams.
• 8.6 PLC Program Case Studies 
• 8.7 Cleanroom Monitoring – Microbiological Tests
  In this lesson, we look at a range of typical microbiological measurements to monitor a cleanroom environment for conformance to specifications.
• 8.8 Cleanroom Monitoring – Cleanrooms Cleaning Procedures 
• 8.9 Terminally Sterilised Products 
• 8.10 EU Guidelines on Cleanroom Aseptic Preparation 

• 9.1 HVAC Critical Parameters for Sterile and Non-Sterile Manufacturing 
• 9.2 Batch Process Control
  In this lesson, we discuss the ISA-88.01 modularization software standard for segmenting a process into physical entities, and into procedural models for instructional recipes. The physical model is used to describe equipment, and the procedural model used to describe recipes (process sequencing).
• 9.3 Nitrogen Supply and Distribution
• 9.4 Environmental Monitoring Program 
  In this lesson, we describe how to monitor a cleanroom environment in order to identify actual and potential sources of contamination using both physical and microbiological techniques.
• 9.5 ICH Q10 – Pharmaceutical Quality System
  This lesson explains the concept of ‘continual improvement’ as part of a company’s quality management system and describes an effective corrective action process and a preventive action process (CAPA). It also gives details on the product-lifecycle for a pharmaceutical product and describes the monitoring of process performance and product quality.
• 9.6 FDA Guidance on Aseptic Processing 

• 10.1 Construction Lifecycle
  In the first lesson for construction lifecycle, we explore the following: choosing a construction type, substructure, options for super-structure, internal building fabric, mechanical installation, electrical & instrumentation, construction sequence for new build, constructability, construction management, construction safety, construction costs, schedule, and quality management. In the second lesson, we look at the contents of clean utility piping test packs. In the third lesson, we look at modular construction and sustainable construction.
• 10.2 Software Functional Block Diagram (FBD)
• 10.3 ASTM E 2500
  In this lesson, we review the ASTM International standard E 2500 – 07 ‘Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment’.

• Calculating Mass Balances and Equipment Sizing
• Designing a Clean Utility generation and distribution system
• Defining the cleanroom layout for safe material and personnel flows
• Describing the Quality System necessary for manufacturing safe medicines

You will receive an end of course certificate from GetReskilled which along with others modules can build into an academic accreditation from the Technological University Dublin (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.

• What’s new in Quality and in Validation
• International Conference on Harmonization (ICH) Overview
• ICH Q8, Q9, Q10 & Q11
• Regulatory & Industry Reaction to ICH Guidelines

• ASTM E 2500-07 “Standard Guide for Specification, Design, and Verification of Equipment”
• ISPE Baseline Guide 5 “Commissioning & Qualification”
• ISPE Good Practice Guide “Applied Risk Management for Commissioning & Qualification” (2011)
• ISPE Guide “Science Risk-Based Approach for the Delivery of Systems & Equipment” (2011)

• FDA Guidance for Process Validation (2011)

• The Concept of Quality
• Evolution of Regulations in the EU & US
• Quality Management Systems
• The Quality Manual
• Validation Master Plan
• Supplier & Vendor Qualification

• Process Validation – Critical Quality Attributes (CQA’s)
• Process Validation – Critical Process Parameters (CPP’s)
• Process Validation Protocol
• Executing the Process Validation Study4

• Process Validation Report
• Preparing for the Regulatory Audit
• Periodic Review & Continuous Validation

• Cleaning Validation Strategy
• Cleaning Validation Report

• The Operator/Product Interface
• Health & Safety Regulations

Complete this module with 8 weeks of study and an extra 2 weeks to complete the end of module assignment.

• Risk management during validation planning
• Auditing suppliers and vendors and their quality plans and documentation
• Prepare a product validation strategy and plan
• Prepare a summary validation report