Session 3 – Process & Cleaning Validation and Documentation

• 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.

Session 4 – Risk Management Tools for Scientific Based Decisions

• 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.

Deliverables

• Complete two workshops on Fault Tree Analysis (FTA) and Failure Mode Effect Analysis (FMEA)
• Complete a question booklet that will summarise what you have learnt for the week and help ensure you retain and understand the information.

Session 5 – Chemical and Biopharmaceutical Manufacturing

• 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

Session 6 – Tablet, Aseptic and Sterile Manufacturing

• Topic-3 Tablet Manufacturing
  In this lesson, we will explore the critical process parameters and quality attributes associated with the manufacture of medicinal tablets.
• Topic-4 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.

Deliverables – Complete a question booklet that will summarise what you have learnt for the week and help ensure you retain and understand the information.

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 identifying 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

You will receive an end of course certificate from GetReskilled 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.