Training Modules
 Introduction to Bio-pharma Industry

 Lyophilization for Biologics

 Integrated Commissioning & Qualification

 cGMP Clean-in-Place (CIP) Development

 cGMP Clean-in-Place (CIP) Operations

 cGMP Sterilization

 Quality in Bio-pharma Automation

 Clean Utilities in cGMP Operations


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Introduction to Bio-pharma Industry

This module provides an introduction to the Bio Pharmaceutical Industry. A basic overview of the process of manufacturing a bulk drug substance & drug product will be provided. It highlights the diverse business models that exist in the industry including: Large Scale Manufacturing, Basic Research, Virtual Enterprises, Contract Manufacturing Organizations, Contract Research Organizations, the role of Universities, and Consulting. The role of the FDA and similar regulatory agencies is discussed along with the various industry professional organizations and their role. The module also covers unique aspects on Good Manufacturing Practice, and Good Laboratory Practice. Finally the module will discuss the current industry trends in terms of manufacturing migration, international equipment vendors, and the latest FDA positions and rulings.

Target Audience: Professionals looking to get a basic understanding of the biologics industry in terms of looking for new opportunities.

Length: 4 hrs

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Lyophilization for Biologics

This module, provides the basic physicochemical foundations of lyophilization and the engineering aspects of an industrial lyophilization process. Most industrial freeze-drying used to manufacture stable drug products, is accomplished using four (4) sub-processes: Refrigeration, Vacuum, Drying (Primary & Secondary), & Final Stoppering. The module discusses each of these sub-processes in detail and demonstrates their sequence in an industrial lyophilizer to produce an acceptable final product. The module addresses steps taken to qualify a typical industrial lyophilizer from installation (IQ), operation (OQ) through Performance (PQ). The module discusses sterilization and cleaning processes used to maintain the lyophilizer in a validated state during production. After completing this module, the trainee should have a basic understanding of lyophilization as well as be able to participate in a team for operation and qualification of a cGMP Lyophilizer.
Target Audience: Process, plant and project engineering, Operations/Manufacturing and Quality professionals attempting to develop a working understanding of the freeze-drying of drug products
Length: 4 hrs

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Integrated Commissioning & Qualification

This module provides personnel a working understanding to completing commissioning and qualification of cGMP process equipment/utilities.

Target Audience: Engineering, Quality and Operations personnel
Length: 4 hrs x 2

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cGMP Clean-in-Place (CIP) Development

This module provides engineering personnel with an overview of key Clean In Place (CIP) concepts required for successful cleaning of Process Equipment.

Target Audience: Process, plant and project engineering, professionals attempting to develop a CIP cycles
Length: 4 hrs

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cGMP Clean-in-Place (CIP) Operations

This module provides Operations personnel with an overview of key Clean In Place (CIP) concepts required for successful cleaning of Process Equipment.

Target Audience: Operations running daily CIP cycles
Length: 4 hrs

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cGMP Sterilization

Sterilization is used to render process equipment used in cGMP manufacturing free of viable organisms. This module focuses on steam sterilization with a brief overview of other sterilization processes, i.e. Dry heat, Ethylene Oxide gas, Vaporized Hydrogen Peroxide, High energy radiation (Gamma and Electron beam). The theoretical discussion on Sterility Assurance limits, D value, Z value, Biological indicators, Lethality calculations, “Cold spots” is combined with achieving successful daily sterilization. The module provides steps taken to complete the IQ, OQ, and PQ of an Industrial Steam Sterilizer. Guidelines are provided to develop and validate sterilization processes for cGMP manufacturing process equipment e.g. Fermentors, Vessels, Lyophilizers, In-line Air filters, Transfer lines. After completing this module, the trainee should have a basic understanding of steam sterilization as well as be able to participate in a team for operation and qualification of a cGMP Autoclave.
Target Audience: Process, plant and project engineering, Operations/Manufacturing and Quality professionals attempting to develop a working understanding of steam sterilization of process equipment.
Length: 4 hrs

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Quality in Bio-pharma Automation

This module provides Quality insight of automation systems used within the bio-pharma manufacturing industry including Building Automation Systems (BAS), Distributed Control Systems (DCS), Programmable Logic Controllers (PLCs), Information Management Systems.

Target Audience: Quality Associates & Managers, Validation Specialists & Managers, QA Auditors, Production Supervisors
Length: 4 hrs

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Clean Utilities in cGMP Operations

This module provides experienced mechanics with an overview of key maintenance and troubleshooting concepts associated with Clean Utilities (e.g. Clean Steam, Water-for-injection, Compressed Air).

Target Audience: Facility Services - Maintenance and Instrumentation Technicians
Length: 4 hrs

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