• Topic-5 API Regulatory Guidelines
  In this lesson, we describe the characteristics of a GMP that can be followed to manufacture an API.
• Topic-6 ISO-9001 ‘Continual Improvement’ & 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.
• Topic-7 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.
• Topic-8 FDA Medical Device Rules-CFR820
  In this lesson, we look at how the FDA classifies medical devices and explore the basis of that classification system.
• Topic-9 Medical Device Regulations and Guidelines – ISO 13485 / CFR 820
  In this lesson, we look at some GMP regulatory and ISO guidance documents that are associated with the manufacture of medical devices.

• Topic-1 Process Validation
  In this lesson, we will learn about the various definitions of ‘validation’, as well as for ‘commissioning’, ‘qualification’ and ‘verification.
• Topic-2 ASTME2500 – Standard Guide for Specification, Design and Verification
  In this lesson, we will describe a specification, design, and verification approach for equipment systems associated with the pharmaceutical, biopharmaceutical and medical device industries.
• Topic-3 PQ,OQ and IQ
  In this lesson, we are going to define the terms installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ), and we will also list what typical project design documents are required to prepare such testing protocols.
• Topic-4 Cleaning Validation
  This class takes a high-level look at a typical cleaning validation sequence. It looks at how to determine the basis for quantification limits and explains how to determine cleanliness levels on the basis of the analytical testing of representative samples. Sampling is described in terms of sampling-equipment, sampling -locations, and sampling –procedures.

• Topic-1 Introduction to Quality Risk Management (QRM)
  In this lesson, we will develop an understanding of the history and the crucial importance of risk management as well as the basic steps involved in its application.
• Topic-2 Fault Tree Analysis (FTA) – step 4 ‘Workshop’ exercise
  In this lesson, we learn about the risk management tool ‘Fault Tree Analysis’ and see an example of where and how we can use it.
• Topic-3 Failure Mode, Effects (and Criticality) Analysis (FMEA / FMEAC) – Step 4 ‘Workshop’ exercise
• This presentation shows an example of the main steps in performing a ‘Failure Mode, Effects Analysis’ (FMEA) and describes how this risk management technique summarizes the important modes of (a) failure, (b) factors causing these failures, and (c) the likely effects of these failures.
• Topic-4 Documenting the Quality Risk Management Process
  In this lesson, we take a practical look at managing a complete risk management process in terms of identifying risk, analyzing risk, evaluating risk, and controlling risk.

• Topic-1 Batch Organic Chemical Synthesis
  In this lesson, we describe the typical equipment and process stages of the manufacture of active pharmaceutical ingredients (API) using batch organic chemistry synthesis
• Topic-2 Biopharmaceuticals Manufacturing, Upstream, Fermentation
  This lesson describes a conventional biotechnological process and introduces the following process sequences:
  • Stage-I – Upstream Processing
  • Stage-II – Fermentation / Bio-reaction
  • Stage-III – Downstream Processing

• Topic-1 Tablet Manufacturing
  In this lesson, we will explore the critical process parameters and quality attributes associated with the manufacture of medicinal tablets.
• Topic-2 Aseptic & Sterile Manufacturing
  In this lesson, we look at critical process parameters and quality attributes associated with aseptic processing and terminal sterilization products for parenteral products.

• Topic-1 Purified Water (PUW) Generation, Storage and Distribution
  In these presentations we look at methodologies to generate, store and distribute pharmacopeia grade purified water (PUW).
• Topic-2 Clean Steam Generators
  The objective of this lesson is to demonstrate how we produce clean steam using ‘Single-Effect Distillation’ ‘Multiple-Effect Distillation
• Topic-3 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
• Topic-4 Engineering Aspects of Cleaning, and Cleaning Equipment
  This class discusses how to clean and decontaminate surfaces using CIP (clean-in-place), agitated Immersion, static Immersion (Soaking), and automated parts washers, ultrasonic cleaning, high-pressure spraying, and manual cleaning
• Topic-5 Chemistry Aspects of Cleaning
  This lesson explores chemistry aspects of cleaning in terms of solubility, solubilisation, emulsification, dispersion, wetting, hydrolysis, oxidation and physical removal.
• Topic-6 Steam Sterilization in Place
  In this lesson, we look at the mechanism behind the sterilization of process equipment using saturated steam.

• Topic-1 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.
• Topic-2 Cleanroom Layout
  In these presentations, 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.
• Topic-3 Area Classification Protection
  In this lesson, we observe a range of airlock configurations typically used in combination with safety 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.
• Topic-4 Cleanroom Gowning
  In this lesson, we describe clothing that will minimize dispersion from skin and clothing for personnel working within a cleanroom environment
• Topic-5 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.

Write a 4-5 page essay, which you could present at a job interview to clearly demonstrate your Technical Knowledge and Understanding of the Quality Culture necessary to work in a GMP regulated manufacturing environment. It will confirm your understanding of how to Manufacture Safe Medicines and Medical Devices in a GMP regulated environment and will include the following topics:

• The key requirements of a quality management system
• The manufacturing responsibilities for quality systems
• The cleaning validation sequence and how to determine cleanliness levels
• The documentation of a complete risk management process in terms of identify risk, analyzing risk, evaluating risk and controlling risk.
• The typical equipment and process stages used in the manufacture of active pharmaceutical ingredients
• The critical process parameters and quality attributes associated with the manufacture of tablets.
• The generation, storage and distribution of pharmacopeia grade Purified Water (PUW).
• The common cleanroom configuration and airflow direction that governs personnel and material flows in a biopharmaceutical manufacturing environment

Now you will start the Advanced Career Coaching elements of this course to develop the skills you will need to find a job in this industry.