Classroom Training Courses

  • General Courses

    • Quality Management Systems Training Course (T57)
      The Pharmaceutical Quality System (PQS), supported by ICH Q10, is the key foundation on which product realization depend. 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. We will be using QMS and PQS terms interchangeably throughout this course to establish a holistic approach. Source: International Conference on Harmonization of Technical....
  • Biotechnology

    • Biotechnology Basics Training Course (T18)
      This fundamental course is ideal for professionals that are new to the biotechnology industry, professionals entering new work assignments encompassing biotechnology operations or individuals with previous pharmaceutical industry experience that want to learn the basics of biotechnology . This is a course that is ideal for individuals involved in human resources, economic development, and business and strategic planning efforts. Professionals in quality control, quality assurance, and technical management support will also find it beneficial. Participants in this classroom course will explore the history of the biotechnology industry and will learn the fundamental concepts of biotechnology science. Participants will also learn....
    • Biotechnology Manufacturing Facility Design Training Course (T31)
      Using case studies and exercises this course in facility design provides an overview of the concepts utilized in the development and renovation of sound designs for facilities that manufacture biopharmaceutical products. The course includes a review of biopharmaceutical manufacturing facility design and regulatory issues important in the US and Europe that involve industry trends and changing regulatory policy. Participants will discuss current case studies on a wide array of facility topics, and complete class exercises that involve developing facility scope of work and deliverables to meet corporate economic goals and regulatory requirements. Immediately apply the course objectives using the complimentary....
    • Overview Biotechnology Manufacturing Processes Training Course (T24) - Updated!
      This course provides a comprehensive understanding of biotech manufacturing processes - what makes biopharmaceutical processes different from small molecules. Course content explores the underlying principles of proteins and cells to provide the foundation for how and why processes manufacture therapeutic proteins. The course studies commonly used manufacturing process operations including cell culture and fermentation; harvest and recovery; viral removal and inactivation; purification processes such as tangential flow filtration, centrifugation, size exclusion and adsorptive chromatography. Course topics include: Biotechnology basics Identify and discuss important operating parameters for each bioprocess unit operation and how they impact process performance What parameters are important....
    • Process Validation in Biotechnology Manufacturing (T32)
      The inherent complexity and uncertainty of biotechnology make developing and validating bioprocesses for manufacturing proteins and biopharmaceuticals very difficult. Understanding and using FDA's Process Validation Guideline is critical to establishing and maintaining control of complex processes, as well as achieving regulatory approval of new products. 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. Topics include a comprehensive strategy to process validation; a review of important biotechnology manufacturing processes,....
  • Cleaning

    • CIP System Design, Integration and CIP Chemicals Training Course (T03)
      Clean-in-place design integration and cleaning chemical selection are vital components of every pharmaceutical manufacturing process; indeed, all pharmaceutical companies employ some type of cleaning application every day. As a result, FDA inspections of cleaning processes have been occurring with greater frequency in today's highly regulated manufacturing environment. To achieve effective and easily validated cleaning methods is to gain a thorough understanding of cleaning methods. 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....
    • Cleaning Validation Principles Training Course (T17)
      As cleaning technology and detection methodology advance, so do the challenges associated with establishing, managing, and maintaining a scientifically sound cleaning validation program. With the FDA's risk-based regulatory initiatives focusing new attention on the risks of cross-contamination understanding lifecycle management techniques for an effective cleaning validation program is paramount. 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. Additional content includes elements of a cleaning validation program from start to finish, exploring such concepts....
  • Commissioning and Qualification

    • Commissioning and Qualification for New and Renovated Facilities: Guidance and Improvements for Successful Delivery (T55) - New Course!
      The successful delivery of manufacturing facilities , (including small, large, new, expansion, or renovation type projects) regulated by various authorities, poses significant challenges to manufacturers, engineering professionals, and equipment suppliers. These facilities are required to meet all applicable GxP regulations, and to comply with all other relevant local and international governing codes, laws, and regulations. This classroom course is designed to improve the way in which the industry delivers regulated manufacturing capacity: improving the ability to meet documented process requirements, control risks within the manufacturing process, produce high-quality products and consistently operate to meet product and process requirements. Course topics....
    • Commissioning and Qualification Training Course (T40)
      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; producing high quality products and consistent operation to meet product user requirements. Guidance on the transition of an organization’s approach to Commissioning....
    • Quality Assurance for Facilities Management Training Course (T48)
      The successful delivery of manufacturing facilities regulated by various authorities, poses significant challenges to manufacturers, engineering professionals, and equipment suppliers. 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. Through interactive workshops, participants will more fully understand and apply the principles of ASTM E2500-07 and ICH documents (Q8 (R2), Q9, and Q10) to the documented verification of pharmaceutical and biopharmaceutical facilities, systems....
  • Facilities

    • CIP System Design, Integration and CIP Chemicals Training Course (T03)
      Clean-in-place design integration and cleaning chemical selection are vital components of every pharmaceutical manufacturing process; indeed, all pharmaceutical companies employ some type of cleaning application every day. As a result, FDA inspections of cleaning processes have been occurring with greater frequency in today's highly regulated manufacturing environment. To achieve effective and easily validated cleaning methods is to gain a thorough understanding of cleaning methods. 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....
    • Commissioning and Qualification Training Course (T40)
      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; producing high quality products and consistent operation to meet product user requirements. Guidance on the transition of an organization’s approach to Commissioning....
    • 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. The Guide provides valuable information on design, while the USFDA's Guidance helps professionals understand the regulatory context and expectations for sterile drug manufacturing. Immediately apply the course learning objectives using the complimentary copy of the ISPE Baseline ® Guide: Sterile Product Manufacturing Facilities (Third Edition). Using the referenced documents, this course....
    • 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. Participants will review global cGMP regulations, including an update of ISO14644-1 & 2 reflecting 2015 changes, as well as common interpretations of those regulations and how they may apply to their facilities. The class will explore critical issues at each stage of the product lifecycle, from R&D to Manufacturing,....
    • Pharmaceutical Facilities Management Training Course (T26)
      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 facility projects are managed. Each course module introduces key....
    • Pharmaceutical Water Systems (T35)
      Pharmaceutical Water is, perhaps, the most important of all pharmaceutical utilities. It is used as an excipient in many pharmaceutical formulations, as a cleaning agent, and as a separately packaged product diluent. In addition to non-compendial systems, pharmaceutical facilities typically include systems for delivering pharmacopoeial Purified Water (PW) Water for Injections (WFI), and Highly Purified Water (HPW). 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....
    • Quality Assurance for Facilities Management Training Course (T48)
      The successful delivery of manufacturing facilities regulated by various authorities, poses significant challenges to manufacturers, engineering professionals, and equipment suppliers. 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. Through interactive workshops, participants will more fully understand and apply the principles of ASTM E2500-07 and ICH documents (Q8 (R2), Q9, and Q10) to the documented verification of pharmaceutical and biopharmaceutical facilities, systems....
    • 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. The course material will cover methods for determining the appropriate distribution and storage strategy, including sanitization method, for various operating circumstances including an overview of optional distribution approaches and the advantages and disadvantages of each. Microbial....
  • GAMP®

    • GAMP 5 GxP Process Control Training Course (T21)
      This highly interactive classroom 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. The course covers recommended good practice based on a lifecycle approach for the development and management of process control systems and shows how the principles and concepts of GAMP 5 may be practically applied to process control systems. The course covers both regulated company and supplier quality management systems and the full system life cycle from concept to retirement.....
    • GAMP 5, Annex 11/Part 11 Basic Principles Training Course (T45)
      This Classroom training course has been updated to include the new revised EU GMP Annex 11 , and an update on 21 CFR Part 11 . This 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. The course does not aim to cover detailed and highly technical aspects of software and hardware engineering, but rather gives the principles and....
    • GAMP Basic Principles Training Course (T07)
      This classroom course has been updated to include the new revised EU GMP Annex 11 , and an overview of 21 CFR Part 11 . 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. The course does not aim to cover detailed and highly technical aspects....
    • GAMP Data Integrity 21 CFR Part 11 Training Course (T50)
      The importance and amount of data being generated to ensure product quality and patient safety continues to grow and proper controls around that data continue to be questioned. Regulatory agencies across the world are noticing a significant increase in data integrity issues. As a result, they are being forced to re-evaluate industry guidance and their enforcement strategies. Regulatory concerns and warning letters have extended to all areas of the pharmaceutical business, including manufacturing, development, clinical, pharmacovigilance and other areas of the product lifecycle. This course will cover data integrity , electronic records and signatures, and the compliant operation of GxP....
    • GAMP® Part 11 Training Course (T08)
      Using the GAMP® Guide: Records and Data Integrity as a resource, this course will give participants a practical introduction to the 21 CFR Part 11 regulation, which affects all aspects of computerized systems in the pharmaceutical industry and up-to-the-minute information on current FDA interpretations. Taught through classroom presentations, workshop sessions, and team exercises, the course will present an overview of Part 11 including its objectives, benefits, and potential problems. This will be followed by a detailed analysis of Part 11 requirements, a discussion of electronic records and signatures, and key industry issues. A central element of this classroom course will....
    • Practical Application of Computerized Systems Compliance: Applying the GAMP® 5 Guide: A Risk-based Approach to Compliant GxP Computerized Systems (T11)
      This highly interactive classroom workshop gives participants hands-on experience in applying practical techniques and solutions to solve computerized systems compliance challenges. Participants will discuss and analyze case studies, apply newly acquired knowledge to hypothetical case-study systems, and have the opportunity to discuss their own real-life challenges with other participants and an expert trainer. Participants should come prepared to work in groups to devise workable and creative solutions to realistic problems and case study scenarios, facilitated by the instructor. Immediately apply the course learning objectives using the complimentary copy of the GAMP® 5 Guide: A Risk-based Approach to Compliant GxP Computerized....
  • 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. The regulation will be divided into six elements: materials, buildings, equipment, records, procedures, and people. Participants will focus on compliance strategies for interpreting the controls needed to continuously operate in a state-of-control, validation, cleaning, and training interpretations will be....
    • GMP Auditing for Quality Assurance Training Course (G07)
      You may also be interested in our training course on Auditing for Medical Devices . Auditing is a critical function within a pharmaceutical company. It provides management with information about how effectively the company controls the quality of their processes and products. Auditors must perform their jobs competently to ensure their company’s compliance with pharmaceutical USFDA GMP regulations and other quality standards like ICH Q10. This Auditing for GMP course is specifically designed to address the challenges of GMP auditing for the pharmaceutical industry and present the basic competencies required to effectively perform the auditor's assigned responsibilities and contribute to....
    • GMP Fundamentals for the Pharmaceutical Industry (G01)
      Through hands-on exercises and lectures , you will discuss and explore GMP principles and approaches for active pharmaceutical ingredients (APIs), excipients, and finished pharmaceuticals. Learn easy-to-grasp basics of regulatory requirements, current issues, and trends in the pharmaceutical industry with an emphasis on applying GMP in day-to-day operations. After understanding the "whys" behind the GMP regulations, participants discuss the history of the GMP regulations, the regulatory process, and the concept of operating in a "state of control," with an emphasis on the regulation of pharmaceutical products. This classroom course is designed to help participants understand the GMPs as they relate to....
    • ICH Q7A GMPs for Active Pharmaceutical Ingredients Training Course (T30)
      Due to the growing pressures from global competitors, high marketing demands, and the requirements of GMP compliance, the bio-pharm industry (brand drugs and generic drug companies) are looking beyond the usual group of closely-knit suppliers. India and China engage in bulk activities and have been generating new dimensional API products with more specialized capabilities than those required by traditional drug products. In order to remain competitive, API manufacturers will need to attune themselves to this evolving dynamic global market. This classroom course covers areas in which compliance requirements differ most from traditional pharmaceuticals and biologics and will review common deficiencies....
  • 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. Participants will review global cGMP regulations, including an update of ISO14644-1 & 2 reflecting 2015 changes, as well as common interpretations of those regulations and how they may apply to their facilities. The class will explore critical issues at each stage of the product lifecycle, from R&D to Manufacturing,....
  • Manufacturing

    • Clinical Trial Materials Training Course (T13)
      CTM Managers continue to play a critical role in a company’s ability to efficiently bring life-saving products to market. Unfortunately in today’s high-pressure and time sensitive research environment, CTM Managers frequently learn while focusing on the specific requirements of an assigned trial, with less priority being given to the critical need for solid training in all aspects of CTM management. 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....
    • Combination Products: Challenges and Expectations Training Course (T47)
      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 for the product, testing, and specifications including....
    • ICH Q7A GMPs for Active Pharmaceutical Ingredients Training Course (T30)
      Due to the growing pressures from global competitors, high marketing demands, and the requirements of GMP compliance, the bio-pharm industry (brand drugs and generic drug companies) are looking beyond the usual group of closely-knit suppliers. India and China engage in bulk activities and have been generating new dimensional API products with more specialized capabilities than those required by traditional drug products. In order to remain competitive, API manufacturers will need to attune themselves to this evolving dynamic global market. This classroom course covers areas in which compliance requirements differ most from traditional pharmaceuticals and biologics and will review common deficiencies....
    • Implementing Process Analytical Technology Training Course (T29)
      Process analytical technology (PAT) is becoming a very important tool for controlling pharmaceutical processes and when implementing Quality by Design. As defined by the USFDA, PAT is "a system for designing, analyzing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-process materials and processes with the goal of ensuring final product quality." As a scientific, risk-based framework, PAT is intended to support innovation and efficiency in pharmaceutical development, manufacturing, and quality assurance and is being seen as a very important tool for Quality by Design. The PAT framework is founded....
    • Managing Cross Contamination with Risk-MaPP Training Course (T41)
      As regulations worldwide are moving to risk-based approaches to determine when shared facilities can be used, manufacturers need tools to help meet the new requirements. The tools include setting appropriate health-based limits, technical and organizational controls, risk management processes, and understanding how to pull it all together in a succinct package for regulators, auditors as well as senior management. When applied properly risk management processes can help reduce costs and increase efficiencies while maintaining patient safety and product quality. This is important as patients and regulators are pushing for lower cost medicines. The key is to understand your risk of....
    • Operational Excellence in Pharma Operations Training Course (T56)
      Operations are defined as the transformative process within a series of activities, along a value chain extending from supplier to customer. Operations Management designs, operates, and improves supply chain systems and provides the pharmaceutical industry with a knowledge base to promote the use of best practices and operational excellence within pharmaceutical operations management. This classroom course is designed to provide participants with a deep understanding of how to measure operational excellence including insights on relevant qualitative enablers as well as meaningful quantitative performance indicators. Using the well-established architecture of the St. Gallen OPEX Benchmarking, this course also leverages this well-established....
    • Oral Solid Dosage Manufacturing Process Training Course (T10)
      Current manufacturing challenges for OSD forms (tablets and capsules), that include Quality, Safety, and Productivity (QSP) continue to be paramount. This interactive course focuses on the quality controls, new technical advancements, production management and operational excellence for raw materials, processes and applications to improve manufacturing. 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. Using a Process and Production Video Simulation for Unit Ops, including Mixing, Blending, Drying, Sizing, Tableting, Encapsulating and Coating provides....
    • Pharmaceutical Technology Transfer Training Course (T19)
      Technology transfer (TT) includes knowledge transfer, science and risk-based principles including ICH Q8, Q9, Q10, Q11 and efficient processes to meet evolving business needs. As the industry continues to experience changes, technology transfer for active pharmaceutical ingredients (APIs), finished dosage forms and analytical methods between development and manufacturing sites and contract manufacturing organizations (CMOs) has become increasingly important. This classroom course identifies criteria for successful technology transfer and provides ‘how to’ examples which can be individually tailored, depending on the type and scope of transfer. It takes into account current industry challenges and real-world examples as tools for industry and....
    • Quality Risk Management Workshop (T42)
      Quality Risk Management (QRM) principles require the evaluation of risk to patient safety and product quality based on scientific knowledge, data and experience. Regulators expect that QRM is inherently built into the backbone of the Quality Management System (QMS) by using a lifecycle approach to implement both formal and informal risk tools that support the elements defined in ICH Q9 for risk assessment, risk control, risk review, communication of identified risks, and acceptance of residual risks. Figure 1: Overview of a typical quality risk management process. ICH Quality Risk Management, Q9 The application and the complexity of risk management tools....
    • Turning QbD into a Practical Reality Training Course (T43)
      Substantial business benefits are emerging from industry when Quality by Design (QbD) principles are used for new and existing drug products yielding reduced operating costs, enabling significantly more efficient manufacturing processes and better positioning companies to meet increasing regulatory expectations. For example, the completion of ICH Guidelines, Q8 (R2): Pharmaceutical Development, Q9: Quality Risk Management and Q10: Pharmaceutical Quality System and the recent USFDA guidance on Process Validation contain recommendations for building and capturing process knowledge and understanding and establishing a strategy for process control during Stage 1, process design. There is evidence from 483s and warning letters that FDA....
  • Project Management

    • Pharmaceutical Facilities Management Training Course (T26)
      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 facility projects are managed. Each course module introduces key....
  • Quality by Design

    • Implementing Process Analytical Technology Training Course (T29)
      Process analytical technology (PAT) is becoming a very important tool for controlling pharmaceutical processes and when implementing Quality by Design. As defined by the USFDA, PAT is "a system for designing, analyzing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-process materials and processes with the goal of ensuring final product quality." As a scientific, risk-based framework, PAT is intended to support innovation and efficiency in pharmaceutical development, manufacturing, and quality assurance and is being seen as a very important tool for Quality by Design. The PAT framework is founded....
    • Process Validation Training Course (T46)
      Lifecycle Process Validation (PV) remains one of the most important and commonly misunderstood topics in the pharmaceutical industry. How many lots should I make? Are we taking enough samples? Do we need to use statistics in our protocols? The real question may be: am I even focusing on the right questions? Course participants will focus on the practical application of the lifecycle approach to all stages of PV to gain valuable knowledge and insight on the regulations, guidance, and best practices currently utilized across the industry. This classroom course is relevant to individuals working throughout the pharmaceutical product lifecycle in....
    • Turning QbD into a Practical Reality Training Course (T43)
      Substantial business benefits are emerging from industry when Quality by Design (QbD) principles are used for new and existing drug products yielding reduced operating costs, enabling significantly more efficient manufacturing processes and better positioning companies to meet increasing regulatory expectations. For example, the completion of ICH Guidelines, Q8 (R2): Pharmaceutical Development, Q9: Quality Risk Management and Q10: Pharmaceutical Quality System and the recent USFDA guidance on Process Validation contain recommendations for building and capturing process knowledge and understanding and establishing a strategy for process control during Stage 1, process design. There is evidence from 483s and warning letters that FDA....
  • Validation

    • Cleaning Validation Principles Training Course (T17)
      As cleaning technology and detection methodology advance, so do the challenges associated with establishing, managing, and maintaining a scientifically sound cleaning validation program. With the FDA's risk-based regulatory initiatives focusing new attention on the risks of cross-contamination understanding lifecycle management techniques for an effective cleaning validation program is paramount. 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. Additional content includes elements of a cleaning validation program from start to finish, exploring such concepts....
    • GAMP 5 GxP Process Control Training Course (T21)
      This highly interactive classroom 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. The course covers recommended good practice based on a lifecycle approach for the development and management of process control systems and shows how the principles and concepts of GAMP 5 may be practically applied to process control systems. The course covers both regulated company and supplier quality management systems and the full system life cycle from concept to retirement.....
    • Process Validation in Biotechnology Manufacturing (T32)
      The inherent complexity and uncertainty of biotechnology make developing and validating bioprocesses for manufacturing proteins and biopharmaceuticals very difficult. Understanding and using FDA's Process Validation Guideline is critical to establishing and maintaining control of complex processes, as well as achieving regulatory approval of new products. 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. Topics include a comprehensive strategy to process validation; a review of important biotechnology manufacturing processes,....
    • Process Validation Training Course (T46)
      Lifecycle Process Validation (PV) remains one of the most important and commonly misunderstood topics in the pharmaceutical industry. How many lots should I make? Are we taking enough samples? Do we need to use statistics in our protocols? The real question may be: am I even focusing on the right questions? Course participants will focus on the practical application of the lifecycle approach to all stages of PV to gain valuable knowledge and insight on the regulations, guidance, and best practices currently utilized across the industry. This classroom course is relevant to individuals working throughout the pharmaceutical product lifecycle in....
  • Water

    • Pharma Water Generation USP WFI & Purified Water Training Course (T04)
      Note: ISPE has two Pharmaceutical Water training courses that we deliver consecutively at our training events. You might also be interested in the Storage Delivery and Qualification of Pharmaceutical Waters training course . Pharmaceutical water is perhaps the most important of all pharmaceutical utilities. It is used as an excipient in many pharmaceutical formulations, as a cleaning agent, and as a separately packaged product diluent. In addition to non-compendial systems, pharmaceutical facilities typically include systems for generating USP Purified Water (PW) and USP Water-For-Injection (WFI). This course has been substantially updated to feature the guiding principles of the ISPE Baseline....
    • Pharmaceutical Water Systems (T35)
      Pharmaceutical Water is, perhaps, the most important of all pharmaceutical utilities. It is used as an excipient in many pharmaceutical formulations, as a cleaning agent, and as a separately packaged product diluent. In addition to non-compendial systems, pharmaceutical facilities typically include systems for delivering pharmacopoeial Purified Water (PW) Water for Injections (WFI), and Highly Purified Water (HPW). 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....
    • 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. The course material will cover methods for determining the appropriate distribution and storage strategy, including sanitization method, for various operating circumstances including an overview of optional distribution approaches and the advantages and disadvantages of each. Microbial....