Classroom Training Courses

  • Cleaning

    • CIP System Design, Integration and CIP Chemicals Training Course (T03)
      This course will provide a fundamental overview of clean-in-place (CIP) systems including design, integration, and selection of cleaning chemicals. Participants will discuss engineering concepts, principles, and integration of CIP systems, clean-out-of-place (COP) systems, or immersion parts washers. While there will be some discussion of manual cleaning practices, cleaning principles will be primarily introduced as they relate to the dynamics of CIP and COP technologies, with an emphasis on selecting the right cleaning chemistries for specific soil residue
    • Cleaning Validation Principles Training Course (T17)
      This course covers the risk-based approach to cleaning development and verification; risk analysis; procedures and evaluation tools including FMEA / FMECA, master planning, risk control, PAT, periodic assessment and monitoring, risk review and communication.
  • Commissioning and Qualification

    • Commissioning and Qualification Training Course (T40)
      Science and Risk-based Commissioning and Qualification - Applying the ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification (T40) Overview Through interactive workshops, this course will explain and apply the science and risk-based approach to verification of systems, equipment and facilities in accordance with the ICH documents Q8 (R2), Q9, and Q10 and ASTM E2500. Topics covered include the principles and activities that constitute an efficient and acceptable approach to demonstrating facility and equipment fitness for use as required by major global regulatory authorities; improving the ability to meet documented process requirements; controlling risks within the manufacturing process;
    • Facilities Management Training Course (T48)
      This interactive classroom course will provide the learner with tools on how to implement a sustainable approach to a risk-based C&Q program, integrate the new C&Q program into existing quality systems, Quality Assurance and Engineering Management Systems and define organizational capabilities to support the new C&Q program.
  • Facilities

    • CIP System Design, Integration and CIP Chemicals Training Course (T03)
      This course will provide a fundamental overview of clean-in-place (CIP) systems including design, integration, and selection of cleaning chemicals. Participants will discuss engineering concepts, principles, and integration of CIP systems, clean-out-of-place (COP) systems, or immersion parts washers. While there will be some discussion of manual cleaning practices, cleaning principles will be primarily introduced as they relate to the dynamics of CIP and COP technologies, with an emphasis on selecting the right cleaning chemistries for specific soil residue
    • Commissioning and Qualification Training Course (T40)
      Science and Risk-based Commissioning and Qualification - Applying the ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification (T40) Overview Through interactive workshops, this course will explain and apply the science and risk-based approach to verification of systems, equipment and facilities in accordance with the ICH documents Q8 (R2), Q9, and Q10 and ASTM E2500. Topics covered include the principles and activities that constitute an efficient and acceptable approach to demonstrating facility and equipment fitness for use as required by major global regulatory authorities; improving the ability to meet documented process requirements; controlling risks within the manufacturing process;
    • Facilities Management Training Course (T48)
      This interactive classroom course will provide the learner with tools on how to implement a sustainable approach to a risk-based C&Q program, integrate the new C&Q program into existing quality systems, Quality Assurance and Engineering Management Systems and define organizational capabilities to support the new C&Q program.
    • GMP Sterile Pharmaceutical Manufacturing Facility Training Course (T12)
      This classroom course uses the second edition of the ISPE Baseline® Guide: Sterile Product Manufacturing Facilities and the FDA's Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice to provide an understanding of the key requirements and GMPs for sterile manufacturing facilities.
    • HVAC cGMP Regulations Training Course (T14)
      This classroom course focuses on common issues and problems in the operation of a facility and maintaining readiness for cGMP inspection. Topics include control system alarm management, common system construction deficiencies, cGMP documentation, maintaining an "inspection ready" state, frequency of testing and balancing, airflow visualization, air change rate reduction and more.
    • Pharma Facilities Project Management Training Course (T26)
      Facility Project Management in the Regulated Pharmaceutical Industry (T26) Overview This classroom course aims to deliver more than the usual project basics and will develop the concept of the project lifecycle from initiation through to delivery of business benefits, providing tools to manage all project resources. It is specifically targeted to the needs of facility projects within the regulated pharmaceutical industry and demonstrates the value inherent in the use of “good practice” project management in the regulated pharmaceutical environment. Trends in regulatory compliance, environmental, health and safety legislation, project delivery methodologies and product speed to market expectations all impact how
    • Pharmaceutical Water Systems (T35)
      This classroom course has been substantially updated to feature the guiding principles of the ISPE Baseline Guide: Water and Steam Systems (Second Edition) with particular emphasis placed upon microbial control and laboratory water as well as key design philosophies. The principles of design and operation of water systems used directly in pharmaceutical manufacturing and laboratory applications, including the essential concepts and principles of systems used to generate USP, EP and non-compendial waters will be covered.
    • Storage, Delivery and Qualification Pharma Water Training Course (T23)
      This classroom course will explore the essential concepts and principles of specification, design, commissioning/qualification of equipment and systems used to store and distribute water in pharmaceutical manufacturing. The course has been substantially updated to feature the guiding principles of the ISPE Baseline® Guide: Water and Steam Systems (Second Edition) with particular emphasis placed upon the new chapters for microbial control, laboratory water and rouging.
  • GAMP®

    • GAMP® 5 GxP Process Control Training Course (T21)
      This GAMP 5 GxP Process Control Training Course describes how the GAMP® Good Practice Guide: A Risk Based Approach to GxP Process Control Systems, may be applied to achieve process control systems that are fit for intended use and meet current regulatory requirements.
    • GAMP 5®, Annex 11/Part 11 Basic Principles Training Course (T45)
      This two or three-day fundamental course introduces participants to regulatory requirements for computerized systems in the pharmaceutical industry and explores tried, tested, and internationally recognized methods of meeting those requirements. GAMP® guidance provides a pragmatic and effective framework for achieving computerized systems that are fit for intended use and meet current regulatory requirements. Please click the "Locations and Registrations" table to select the two or three-day sessions.
    • GAMP® Basic Principles Training Course (T07)
      This fundamental course introduces participants to regulatory requirements for computerized systems in the pharmaceutical industry and explores tried, tested, and internationally recognized methods of meeting those requirements. GAMP guidance provides a pragmatic and effective framework for achieving computerized systems that are fit for intended use and meet current regulatory requirements, by building upon existing industry good practice in an efficient and effective manner.
    • GAMP® Part 11 Training Course (T08)
      This classroom course will be an explanation of the GAMP approach to 21 CFR Part 11 compliance, as well as compliance with other international regulations covering electronic records and signatures.
  • GMPs

    • Applying the GMPs (G03)
      The highly interactive classroom course uses extensive exercises to provide an intense examination and interpretation of the cGMP regulations with special emphasis on applying the "right dose" of GMP to various situations to assure that methods, facilities, and controls are used for the manufacture processing, packing, or holding of drug products to meet requirements for safety, identity, strength, quality, and purity.
    • GMP Fundamentals for the Pharmaceutical Industry (G01)
      This classroom course is designed to help participants understand the GMPs as they relate to the pharmaceutical industry. Participants will gather information about both European regulators and the FDA, how the various agencies enforce GMP requirements, and what to expect during a routine GMP inspection. They will examine and discuss the process of a regulatory inspection and gain valuable insight into the compliance auditing process.
    • ICH Q7A GMPs for Active Pharmaceutical Ingredients Training Course (T30)
      This classroom course covers areas in which compliance requirements differ most from traditional pharmaceuticals and biologics and will review common deficiencies and problem areas related to the ICH Harmonised Tripartite Guideline Good Manufacturing Practice Guide For Active Pharmaceutical Ingredients Q7 and the USFDA's interpretation of ICH Q7, as defined in Q7A, the Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.
  • HVAC

    • HVAC cGMP Regulations Training Course (T14)
      This classroom course focuses on common issues and problems in the operation of a facility and maintaining readiness for cGMP inspection. Topics include control system alarm management, common system construction deficiencies, cGMP documentation, maintaining an "inspection ready" state, frequency of testing and balancing, airflow visualization, air change rate reduction and more.
  • Manufacturing

    • Clinical Trial Materials Training Course (T13)
      In this classroom course, you will receive a thorough overview of the clinical supply chain from beginning to end, including: designing appropriate packaging and labeling to match the study design, creating a plan of action to prepare the CTM and how to implement the plan and troubleshoot. The course will also cover the logistics of distribution of the CTM to the clinical sites globally. Important tools, such as outsourcing vendors for packaging and labeling and Interactive Response Technology will be covered to ensure familiarity with all the necessary concepts.
    • Combination Products: Challenges and Expectations Training Course (T47)
      Combination Products: Challenges and Expectations (T47) Overview With the increasing regulatory scrutiny on combination products, this new highly interactive course provides six (6) different aspects of a combination product which are: Combination Product GMPs Criticality of Design Input and how to define the requirements Design Verification and Validation approaches What to expect and considerations for Clinical Trial for Combination Products Human Factors for Combination Products Post Market Considerations An overview and the intricacies of the GMPs for combination products will be provided that specifically address the challenges and expectations from industry and global regulatory agencies. The development of the basis
    • ICH Q7A GMPs for Active Pharmaceutical Ingredients Training Course (T30)
      This classroom course covers areas in which compliance requirements differ most from traditional pharmaceuticals and biologics and will review common deficiencies and problem areas related to the ICH Harmonised Tripartite Guideline Good Manufacturing Practice Guide For Active Pharmaceutical Ingredients Q7 and the USFDA's interpretation of ICH Q7, as defined in Q7A, the Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.
    • Implementing Process Analytical Technology Training Course (T29)
      This classroom course is designed to help pharmaceutical manufacturing professionals chart a new course for innovation based on PAT. The course provides an overview to the tools and principles outlined in the FDA guidance, PAT - A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance.
    • Oral Solid Dosage Manufacturing Process Training Course (T10)
      This classroom course examines current technology and provides scenario-based exercises for system troubleshooting and investigational events for process deviations, discusses quality management and GMP inspection preparation, and provides guidance on advanced asset lifecycle management strategy.
    • Quality Risk Management Workshop (T42)
      This highly interactive, 3 day advanced workshop uses case studies to provide practical tools and techniques to identify solutions for applying QRM principles to current challenges and provides hands-on experience with preparing for and facilitating risk assessments.
  • Project Management

    • Pharma Facilities Project Management Training Course (T26)
      Facility Project Management in the Regulated Pharmaceutical Industry (T26) Overview This classroom course aims to deliver more than the usual project basics and will develop the concept of the project lifecycle from initiation through to delivery of business benefits, providing tools to manage all project resources. It is specifically targeted to the needs of facility projects within the regulated pharmaceutical industry and demonstrates the value inherent in the use of “good practice” project management in the regulated pharmaceutical environment. Trends in regulatory compliance, environmental, health and safety legislation, project delivery methodologies and product speed to market expectations all impact how
  • Quality Management Systems

    • Quality Management Systems Training Course (T57)
      Through lecture and group exercises this course illustrates how quality systems work, the purpose of the different elements, how they connect to each other and how to recognize and transfer knowledge/connectivity throughout the organization. The diagram below from ICH Q10, covers the product life cycle for a PQS/QMS system and all aspects will be covered by this course.
  • Validation

    • Cleaning Validation Principles Training Course (T17)
      This course covers the risk-based approach to cleaning development and verification; risk analysis; procedures and evaluation tools including FMEA / FMECA, master planning, risk control, PAT, periodic assessment and monitoring, risk review and communication.
    • GAMP® 5 GxP Process Control Training Course (T21)
      This GAMP 5 GxP Process Control Training Course describes how the GAMP® Good Practice Guide: A Risk Based Approach to GxP Process Control Systems, may be applied to achieve process control systems that are fit for intended use and meet current regulatory requirements.
    • Process Validation in Biotechnology Manufacturing (T32)
      This classroom course is designed to provide a clear understanding of the regulatory, scientific, and engineering tools required to successfully develop and validate bioprocesses. In addition, the course identifies the long list of activities required to validate biopharmaceutical processes.
    • Process Validation Training Course (T46)
      This classroom course is relevant to individuals working throughout the pharmaceutical product lifecycle in development, manufacturing, quality, and many other roles involved in validation of products and processes. It will help you integrate and link the science and risk-based lifecycle approach for Process Validation to your overall Pharmaceutical Quality System.
  • Water

    • Pharma Water Generation USP WFI & Purified Water Training Course (T04)
      This classroom course will cover the principles of design and operation of water systems used directly in pharmaceutical manufacturing and laboratory applications, including the essential concepts and principles of systems used to generate USP and non-compendial waters. These concepts include specification, design, operation, testing, and maintenance of equipment and systems for water generation.
    • Pharmaceutical Water Systems (T35)
      This classroom course has been substantially updated to feature the guiding principles of the ISPE Baseline Guide: Water and Steam Systems (Second Edition) with particular emphasis placed upon microbial control and laboratory water as well as key design philosophies. The principles of design and operation of water systems used directly in pharmaceutical manufacturing and laboratory applications, including the essential concepts and principles of systems used to generate USP, EP and non-compendial waters will be covered.
    • Storage, Delivery and Qualification Pharma Water Training Course (T23)
      This classroom course will explore the essential concepts and principles of specification, design, commissioning/qualification of equipment and systems used to store and distribute water in pharmaceutical manufacturing. The course has been substantially updated to feature the guiding principles of the ISPE Baseline® Guide: Water and Steam Systems (Second Edition) with particular emphasis placed upon the new chapters for microbial control, laboratory water and rouging.