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ISPE’s Body of Knowledge is viewed by manufacturing professionals and regulators worldwide as the go-to resource for information.

We draw from the expertise of our members to develop training courses that address industry demands and deliver in-depth knowledge, utilizing ISPE Guidance documents, team exercises and case studies to provide tangible take-a-ways.

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Questions?Contact us during regular business hours, Monday through Friday, 08.00 to 17.00 EST at +1-813-960-2105 or ask@ispe.org.

Gain solutions to your company's immediate goals to lower production costs, improve process efficiency, increase production quality and meet regulatory requirements.

Biotechnology

  • An Overview of Biopharmaceutical Manufacturing Processes (T24)
    Gain an in-depth understanding of how and why biotech processes work. Discuss the relationships between product, process, and facility attributes and current regulatory guidance impacting process development and execution. Compare various process aspects of upstream and downstream operations and recognize options available for single use technologies.

  • Applying the Biopharmaceutical Manufacturing Facilities Baseline® Guide Principles (T31)
    Use case studies and exercises to understand the concepts used in development and renovation of sound designs for facilities that manufacture biopharmaceuticals. The course includes a review of facility design and regulatory issues important in the US and Europe. Using current case studies on a wide array of facility topics, the class exercises involve developing facility scope of work and deliverables to meet corporate economic goals and regulatory requirements.

  • Biotechnology Basics (T18)
    Explore the history of the biotechnology industry and learn the fundamental concepts of biotechnology science, basic terminology and how it applies in the industry. Identify basic process science and unit operations for the manufacture of products learn the regulatory foundation that makes biological products different from traditional pharmaceutical products.

  • Process Validation in Biotechnology Manufacturing (T32)
    Understanding and using USFDA's Process Validation Guideline is critical to establishing and maintaining control of complex processes, as well as achieving regulatory approval of new products. Learn to develop and execute validation master plans and validation protocols and successfully run conformance lots for process qualification. Apply strategies and fundamental approaches for process validation of upstream and downstream processes for clinical and commercial manufacturing and discuss validation documentation requirements.

Cleaning

  • Clean in Place Fundamentals (T03)
    Discuss an overview of clean-in-place (CIP) systems including design, integration, and selection of cleaning chemicals. Learn 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 residues.

  • Cleaning Validation Principles (T17)
    Understand the elements of a cleaning validation program from start to finish, exploring such concepts as the determination of residues to be targeted, selection of analytical and sampling methods, determination of appropriate limits in various pharmaceutical and biotechnology processes, and establishment of scientific rationales acceptable to regulatory inspectors. For mature cleaning validation programs, concepts such as understanding process control, capability, learning to effectively self-audit a cleaning validation program, and documentation will be essential takeaways.

Commissioning and Qualification

Facilities

  • Clean in Place Fundamentals (T03)
    Discuss an overview of clean-in-place (CIP) systems including design, integration, and selection of cleaning chemicals. Learn 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 residues.

  • Facility Project Management in the Regulated Pharmaceutical Industry (T26)
    Develop the concept of the project lifecycle from initiation through delivery of business benefits using the tools provided in this course to manage all facility projects. A case study will be used illustrate key points for Project Initiation, Design Planning and Delivery, Procurement, Construction, C&Q and Project Close-Out and Review.

  • HVAC (T14)
    Review global cGMP regulations and their common interpretations and explore critical issues at each stage of the product lifecycle, from R&D to manufacturing, such as: controlling cross-contamination between products, determining the correct classification of spaces, maintaining proper control of storage temperature and humidity, setting acceptance criteria for HVAC systems and using risk assessment to set environmental criteria. Workshops include templates to immediately apply the course objectives.

  • Pharmaceutical Water Generation (T04)
    Review regulatory requirements for water treatment systems, unit process performance characteristics and design parameters. Understand the quality requirements and the difference between compendial, non-compendial and laboratory water systems; system alternatives and maintenance practices to identify issues and troubleshoot components.

  • Pharmaceutical Water Systems (T35)
    Differentiate regulatory requirements from myths relative to water generation, distribution and storage systems; identify alternative system designs and their advantages and disadvantages; understand the importance of microbiological control and analyse the principles behind water system testing and qualification. Understand the impact of water quality requirements (compendial and non-compendial) on water system operations; define the basic requirements for water distribution system component installation and overall system construction, and integrate and streamline commissioning and validation activities.

  • Risk-Based Verification of Facilities, Systems and Equipment Workshop (T48)
    Using interactive workshops apply ASTM E 2500-07 principles and ICH Q8(R2), Q9, and Q10 to the documented verification of pharmaceutical and biopharmaceutical facilities. Templates will be developed to facilitate the translation of the scientific knowledge about the product and process into documented specification, design, and verification of facilities, systems, and equipment.

  • Science and Risk-based Commissioning and Qualification - Applying the ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification (T40)
    Through interactive workshops, apply the science and risk-based approach to verification of systems, equipment and facilities in accordance with the ICH Q8, Q9, and Q10 and ASTM E-2500. Guidance will be provided to transition to a C&Q program that incorporates a science and risk-based approach.

  • Sterile Product Manufacturing Facilities: Applying the ISPE Baseline® Guide and FDA Guidance Principles to Design and Operation (T12)
    Review regulatory philosophy, aseptic process and equipment considerations, aseptic clean room design and operation, differential pressure requirements, airlocks, and basic utility systems. European HVAC considerations and a brief introduction to barrier isolation technology along with. Exercises in the layout of an aseptic filling facility are included.

  • Storage Delivery and Qualification of Pharmaceutical Waters (T23)
    Learn alternative designs for water storage and distribution systems and the advantages and disadvantages of each. Analyze the principles behind water system testing and qualification; understand the impact of water quality requirements on system operations, define basic requirements for distribution system components and overall system construction while integrating commissioning and validation activities.

GAMP

GMPs

  • Applying the GMPs (G03)
    Use extensive exercises examine and interpret cGMP regulations with emphasis on applying the GMPs 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 is into six elements: materials, buildings, equipment, records, procedures, and people.

  • GMP Auditing for the Pharmaceutical Industry (G07)
    Understand the competencies, tools and techniques required to effectively perform internal audits and improve processes and product quality. This course does not prepare companies to be audited and does not contain content for medical device auditing.

  • GMP Fundamentals for the Pharmaceutical Industry (G01)
    Explore GMP principles and approaches for APIs, excipients, and finished pharmaceuticals. Learn the basics of regulatory requirements, current issues, and trends with an emphasis on applying GMP in day-to-day operations. 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.

  • Q7A: Implementing Good Manufacturing Practices (T30)
    Biotech and pharmaceutical companies that manufacture APIs face a host of compliance issues unique to their processes. This course reviews and interprets the key GMP requirements specific to bulk biopharmaceuticals and familiarizes participants with the USFDA's interpretation of ICH Q7, as defined in Q7A.

HVAC

  • HVAC (T14)
    Review global cGMP regulations and their common interpretations and explore critical issues at each stage of the product lifecycle, from R&D to manufacturing, such as: controlling cross-contamination between products, determining the correct classification of spaces, maintaining proper control of storage temperature and humidity, setting acceptance criteria for HVAC systems and using risk assessment to set environmental criteria. Workshops include templates to immediately apply the course objectives.

Manufacturing

  • Applying Quality Risk Management (QRM) (T42)
    Through interactive workshops, QRM program principles that need to include ICH Q10 within the product/system lifecycle will be explored including the application of a holistic QRM process through the development of a QRM plan; implementing a risk decision tree; appropriate use of risk assessment tools; applying risk management methodologies to design and verification phases; a Risk Dashboard; and US/EU/FDA/ and WHO regulatory requirements.

  • Clinical Trial Materials: Applying Production, Quality Assurance and Packaging Processes (T13)
    Understand the clinical supply chain and translate a clinical study protocol to define CTM supply requirements and use documentation, cGMPs, and regulatory considerations specifically affecting CTM. Know how to prepare a project plan for all major steps in CTM production, Identify the roles of the project team and how CTM interacts with each one and apply real-life case studies to your own projects.

  • Combination Products: Challenges and Expectations (T47)
    With the increasing regulatory scrutiny on combination products this highly interactive course provides combination product GMPs, the criticality of design input, design verification and validation, considerations for clinical trials, human factors and post market considerations.

  • Implementing Process Analytical Technology (T29)
    This 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. Concepts to help organizations meet regulatory requirements for validating and controlling the manufacturing process also are provided.

  • Managing the Risk of Cross Contamination: Applying the Risk-MaPP Baseline® Guide (T41)
    By properly managing the risk of cross contamination, manufacturers can reap the benefits of lower costs and higher efficiency while maintaining product quality and patient safety. Using ICH Q9 , this course will focus on using the logic diagram, how health based limits are developed, setting cleaning validation limits, risk assessments for cross contamination and formulating a Quality Risk Management Plan as part of a Quality System.

  • Oral Solid Dosage Forms: Understanding the Unit Operations, Process, Equipment and Technology for OSD Manufacture (T10)
    Understand unit operations; explain different methods for performing a unit operation and how product characteristics dictate the unit operations method. Identify the types of equipment; how cGMP influences unit operations; production suite design, and control and monitoring requirements. Learn to use process monitoring techniques during the scale-up and technology transfer exercises.

  • Practical Application of Technology Transfer (T19)
    This 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 regulators to use when conducting and evaluating technology transfer activities.

  • Q7A: Implementing Good Manufacturing Practices (T30)
    Biotech and pharmaceutical companies that manufacture APIs face a host of compliance issues unique to their processes. This course reviews and interprets the key GMP requirements specific to bulk biopharmaceuticals and familiarizes participants with the USFDA's interpretation of ICH Q7, as defined in Q7A.

  • Turning QbD into a Practical Reality (T43)
    Through group exercises the course will delve into implementation and operation of an effective and efficient control strategy in manufacturing which is a key element of process performance and product quality monitoring and continual improvement.

Project Management

  • Facility Project Management in the Regulated Pharmaceutical Industry (T26)
    Develop the concept of the project lifecycle from initiation through delivery of business benefits using the tools provided in this course to manage all facility projects. A case study will be used illustrate key points for Project Initiation, Design Planning and Delivery, Procurement, Construction, C&Q and Project Close-Out and Review.

Quality by Design

  • Implementing Process Analytical Technology (T29)
    This 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. Concepts to help organizations meet regulatory requirements for validating and controlling the manufacturing process also are provided.

  • Practical Implementation of Process Validation Lifecycle Approach (T46)
    Improve process design, qualification of equipment and process performance with technical approaches to reduce operating costs and enable more efficient manufacturing processes. Leverage process design information to establish a process validation strategy and monitoring programs for process performance and product quality. Minimize validation failures with adequate preparation in process understanding and ancillary systems. Understand a variety of methods for expectations of the lifecycle approach to PV, including number of sampling, acceptance criteria and determining the number of batches for PPQ/PV. Define attributes and parameters to be evaluated during PV Stage 3. Gain tools to ensure compliance with USFDA Process Validation guidance and EMA's Process Validation guidelines.

  • Turning QbD into a Practical Reality (T43)
    Through group exercises the course will delve into implementation and operation of an effective and efficient control strategy in manufacturing which is a key element of process performance and product quality monitoring and continual improvement.

Validation

  • A Risk-Based Approach to GxP Process Control Systems: Applying the GAMP® Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems (2nd Edition) (T21)
    This highly interactive course describes how GAMP® principles may be applied to achieve process control systems that are fit for intended use and meet current regulatory requirements. Additional topics include recommended good practice based on a life cycle approach for regulated company and supplier quality management systems; full system life cycle from concept to retirement, and supplier documentation and activities to avoid unnecessary duplication.

  • Cleaning Validation Principles (T17)
    Understand the elements of a cleaning validation program from start to finish, exploring such concepts as the determination of residues to be targeted, selection of analytical and sampling methods, determination of appropriate limits in various pharmaceutical and biotechnology processes, and establishment of scientific rationales acceptable to regulatory inspectors. For mature cleaning validation programs, concepts such as understanding process control, capability, learning to effectively self-audit a cleaning validation program, and documentation will be essential takeaways.

  • Practical Implementation of Process Validation Lifecycle Approach (T46)
    Improve process design, qualification of equipment and process performance with technical approaches to reduce operating costs and enable more efficient manufacturing processes. Leverage process design information to establish a process validation strategy and monitoring programs for process performance and product quality. Minimize validation failures with adequate preparation in process understanding and ancillary systems. Understand a variety of methods for expectations of the lifecycle approach to PV, including number of sampling, acceptance criteria and determining the number of batches for PPQ/PV. Define attributes and parameters to be evaluated during PV Stage 3. Gain tools to ensure compliance with USFDA Process Validation guidance and EMA's Process Validation guidelines.

  • Process Validation in Biotechnology Manufacturing (T32)
    Understanding and using USFDA's Process Validation Guideline is critical to establishing and maintaining control of complex processes, as well as achieving regulatory approval of new products. Learn to develop and execute validation master plans and validation protocols and successfully run conformance lots for process qualification. Apply strategies and fundamental approaches for process validation of upstream and downstream processes for clinical and commercial manufacturing and discuss validation documentation requirements.

Water

  • Pharmaceutical Water Generation (T04)
    Review regulatory requirements for water treatment systems, unit process performance characteristics and design parameters. Understand the quality requirements and the difference between compendial, non-compendial and laboratory water systems; system alternatives and maintenance practices to identify issues and troubleshoot components.

  • Pharmaceutical Water Systems (T35)
    Differentiate regulatory requirements from myths relative to water generation, distribution and storage systems; identify alternative system designs and their advantages and disadvantages; understand the importance of microbiological control and analyse the principles behind water system testing and qualification. Understand the impact of water quality requirements (compendial and non-compendial) on water system operations; define the basic requirements for water distribution system component installation and overall system construction, and integrate and streamline commissioning and validation activities.

  • Storage Delivery and Qualification of Pharmaceutical Waters (T23)
    Learn alternative designs for water storage and distribution systems and the advantages and disadvantages of each. Analyze the principles behind water system testing and qualification; understand the impact of water quality requirements on system operations, define basic requirements for distribution system components and overall system construction while integrating commissioning and validation activities.

Upcoming Training Locations

2016 ISPE Training Institute - September
01 September 2016 - 30 September 2016, Tampa, FL USA

Topics include: Application of GAMP 5 ♦ Biopharmaceutical Overview ♦ Risk-based C&Q
2016 San Diego Training
12 September 2016 - 14 September 2016, San Diego, CA USA

Topic: Basic GAMP® 5 Annex 11/ Part 11
2016 Atlanta Training
22 September 2016 - 23 September 2016, Atlanta, GA USA

Topics include: Clean in Place * Updated! ♦ Technology Transfer ♦ Bio Manufacturing Facilities ♦ Risk-MaPP
2016 Barcelona Training
26 September 2016 - 28 September 2016, Barcelona, Spain

Topics include: HVAC ♦ Technology Transfer ♦ GAMP® 5 Process Control Systems ♦ QRM ♦ Facilities, Systems & Equipment ♦ GAMP Data Integrity - T50 So
2016 Boston Training
17 October 2016 - 20 October 2016, Boston, MA USA

Topics include: Water Generation ♦ Cleaning ♦ Water Storage ♦ Project Management ♦ Biotech Process Validation ♦ QRM ♦ GAMP Data Integrity
2016 Copenhagen Training
31 October 2016 - 02 November 2016, Copenhagen, Denmark

Topic: Basic GAMP® 5 Annex 11/ Part 11
2016 ISPE Training Institute - November
01 November 2016 - 30 November 2016, Tampa, FL USA

Topics include: Auditing ♦ HVAC ♦ GAMP 5 Process Control Systems ♦ Q7A ♦ Facilities, Systems & Equipment
2016 ISPE Training Institute - December
01 December 2016 - 31 December 2016, Tampa, FL USA

Topics include: Oral Solid Dosage Forms ♦ Sterile Facilities ♦ Cleaning ♦ Basic GAMP® 5 Annex 11/ Part 11

* ISPE has been reviewed and approved as a provider of project management training by the Project Management Institute (PMI®)

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On-site Training

ISPE will customize an on-site training program to help you meet specific employee productivity and knowledge requirements. The program will cost less than sending groups to off-site training and can work to fit employee work schedules. More information…

Training Event Sponsorships

Interested in networking with training attendees on topics your firm may specialize in? The majority of training course attendees, depending on the course selected, have been working within their specific area of expertise from 5 to 10 years or more and travel nationally or regionally to attend the event. Although the composition of each class can vary, we frequently have attendees with senior level responsibilities or those who have assumed new responsibilities and projects. Sponsor space is limited; for further information please contact:

Rich Ryan
Telephone: +1-419-734-5545, email: rryan@ispe.org

Save on travel expenses, and learn on your own schedule.

ISPE’s eLearning offerings include online courses and webinars to help you expand your skills and knowledge from the comfort of your desk.

  • New! Expanded Online Training
    With ISPE eLearning Expanded Courses, you can take ISPE's signature training, the type usually delivered over two to three days in a distant classroom, from your home or office.
  • General Industry Knowledge
    These courses offer general industry knowledge while providing an industry overview, historical background and the basic building blocks to get you started and understand more advanced and specific industry topics.
  • Fundamental Industry Knowledge Courses
    ISPE’s pre-recorded courses, which were developed and reviewed by expert instructors and international regulatory advisors.
  • GMP Courses
    Learn the U.S. Food and Drug Administration’s Systems-based GMP Inspection Approach
  • Webinars
    Pre-recorded webinars for over 20- topic specific areas.

eLearning Details »

eLearning Catalog

Through our Learning Dashboard you can find courses by topic or format, customize your learning, track your learning history, and print and track CEUs.

Browse by Topic »

On-site TrainingConvenient, cost-effective and customizable.

A well-trained staff is critical to meeting cGMP regulations. Training can also be the difference between successful operations and regulatory violations.

ISPE can help you prevent performance lapses and stretch your training budget by bringing our courses to you.

By leveraging the combined knowledge of our global membership, our courses provide the practical, "real world" information to meet and exceed regulatory requirements — from instructors who work in the industry and face the same daily challenges you do.

Our instructors will work with you to create a dynamic instructional program where your employees will have the opportunity to apply best practices and seek practical solutions.

For more information contact training@ispe.org, or call ISPE Member Services at +1-813-960-2105.

ISPE onsite training courses have supported the business initiatives of the following companies:

Abbott Laboratories
AbbVie
Alkermes
Allergan, Inc.
Amgen, Inc.
AstraZeneca
Bausch & Lomb, Inc.
Baxter BioScience Manufacturing
Bayer CropScience AG
Elan Corporation
Eli Lilly and Company
Emergent BioSolutions, Inc.
F. Hoffmann-La Roche, Ltd.
Genentech, Inc.
Genzyme Corp.
Gilead Sciences, Inc.
GlaxoSmithKline
H Lundbeck A/S

Health Canada
Johnson & Johnson
Merck & Co., Inc.
Mylan, Inc.
National Centers for Animal Health USDA
National Institutes of Health
Novartis International AG
Ortho-Clinical Diagnostics
Pfizer, Inc.
Regeneron Pharmaceuticals, Inc.
Sanofi Pasteur
Synthes, Inc.
U.S. Department of Veterans Affairs
Ulma Packaging
USFDA
W.L. Gore Associates

ISPE Training Institute

The ISPE Training Institute is located within the ISPE offices in Tampa, FL. With a world-class airport just minutes away and several hotels within easy walking distance, we can provide pharmaceutical manufacturing professionals with the high quality, globally-vetted, in-depth knowledge needed to develop practical solutions.

Scheduled for 2016:

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