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Good Engineering Practices Certificate

Overview

Level: Intermediate
Type: Certificate

ISPE Continuing Education Units (CEUs):  2.8

ISPE’s Good Engineering Practices certificate program is a comprehensive program designed to equip professionals with the knowledge and skills required to effectively manage engineering projects in the pharmaceutical industry. The purpose of this course is to define Good Engineering Practices (GEP) that support and enable the design, delivery, and operation of engineered systems in a regulated industry.  

GEP provides a foundation required across the pharmaceutical industry that other areas, such as GxP, build upon. The curriculum considers the entire range of pharmaceutical engineering activities and identifies key attributes of GEP within it, including how GEP relates to and interfaces with GxP. The scope of GEP covers the complete lifecycle of engineering projects and engineered systems from conceptual design to retirement.  

In the context of pharmaceutical engineering and GxP guidance, GEP is frequently referred to as a prerequisite to compliance activities and may be loosely defined in documents. GEP is often used to describe an engineering management system that is expected in a regulated company, but which is not mandated by GxP regulations.  Effective project progress monitoring and control are — therefore the certificate program emphasizes facility project management skills and offers practical insights into the unique challenges and regulatory requirements of the pharmaceutical industry.  

Benefits

  • Enhanced Competence:  
    • Equip yourself with the latest knowledge and skills in pharmaceutical project management, ensuring you are well-prepared to handle complex projects.
  • Professional Growth:
    • Enhance your career prospects with certificates from a globally recognized organization, demonstrating your commitment to excellence and continuous improvement.
  • Networking Opportunities:
    • Connect with industry experts, peers, and thought leaders, expanding your professional network and gaining insights from diverse experiences.
  • Practical Application:
    • Apply the learned principles through case studies, real-world scenarios, and interactive sessions, ensuring practical understanding and capability.
  • Improved Project Outcomes:
    • Increase the likelihood of project success by adopting proven practices in project management, risk mitigation, and quality assurance, leading to efficient and compliant project delivery. 

The ISPE Good Engineering Practices Certificate is an invaluable investment for professionals aiming to excel in managing pharmaceutical engineering projects, ensuring they are equipped to meet the demands of the industry while adhering to the highest standards of engineering and regulatory compliance. 

Course Curriculum

Course NumberCourse TitleCourse TypeCEUsDays
T75Good Engineering Practices Instructor Led - Virtual1.52
T26Facility Project Management in the Regulated Pharmaceutical Industry ​  Instructor Led - Virtual1.32

Key Takeaways

Good Engineering Practices (GEP)

  • Gain in-depth knowledge of GEP and its application in pharmaceutical facility design, construction, and operation
  • Explore methodologies for ensuring compliance with industry standards and regulatory requirements
  • Understand the breadth and coverage of GEP as a lifecycle process
  • Define the core concepts, key practices, and enablers of GEP
    • Core concepts: risk Management, cost management, organization and control, innovation and continual Improvement
    • Key practices: system lifecycle processes, project engineering management practices, system design practices, system delivery practices, operational support practices, ancillary support practices
  • Enablers: engineering quality process (EQP)
  • Apply quality risk management (QRM) principles to GEP
  • Understand how GEP supports and is an enabler for the QRM-based integrated commissioning and qualification (C&Q) process

Project Management Fundamentals

  • Understand the core principles of project management, including planning, execution, monitoring, and closing
  • Learn to develop project charters, define scope, and set achievable objectives
  • Define a common language within the pharmaceutical project management community
  • Define the relationship between project management and the technical aspects of delivering a project; validation, design, procurement, construction, commissioning and qualification
  • Identify the key areas where compliance to Current Good Manufacturing Practices (CGMP) can be positively impacted by using good practice project management and appropriately manage risk at all stages in the project lifecycle
  • Articulate the key project management concepts, methodologies, and tools applicable to each stage in the lifecycle of a typical pharmaceutical facility project
  • Understand the role of risk management and how it should be integrated into each aspect of a project
  • Effectively integrate hard project management skills (such as cost, change, and schedule controls) with “soft” project management skills (such as project team building, management of sponsors and customers, etc.) to ensure that project objectives are achieved and business benefits delivered
  • Apply the principles of good practice project management within the regulated pharmaceutical environment appreciating the similarities and the differences between facility projects and other project types
  • Understanding of the project management delivery system 

ISPE CEUs

Participants in the Biopharmaceutical Essentials certificate program will earn CEUs for each completed course. These CEUs are valuable for maintaining professional certifications and demonstrating ongoing commitment to professional growth and industry expertise.

Embark on the Biopharmaceutical Essentials certificate program to enhance your skills, expand your knowledge, and advance your career in the dynamic and evolving field of biopharmaceutical manufacturing.

Program Format

The instructor-led course will be presented through lectures, articles, and videos reflecting current pharmaceutical industry requirements, and includes team activities and discussions. 

Course Modules

GEP

  • Introduction:  
    • Module 01: Introduction and Overview of GEP Good Practice Guide  
    • Module 02: Overview of GEP in Support of QRM-Based C&Q  
  • GEP Core concepts  
    • Module 03: Risk Management  
    • Module 04: Cost Management  
    • Module 05: Operations and Control  
    • Module 06: Innovation and Continual Improvement  
  • GEP Practices  
    • Module 07: System Lifecycle Processes  
      • Engineering Change Management  
      • Engineering Issue Management  
      • Engineering Document/Drawing Mgt  
    • Module 07 Workshop 01: Engineering Change Management  
    • Module 08: Project Engineering Management Practices  
    • User Requirement Specification (URS)/Scope Definition  
      • Project Infrastructure  
      • Project Planning and Organization  
      • Project Monitoring and Planning  
    • Module 09: System Design Practices  
      • Boundary Definition  
      • Requirements Definition  
      • Design Development  
      • Design Review  
    • Module 09 Workshop 02: System Boundary Definition  
    • Module 09 Workshop 03: Design Development/Design Review  
    • Module 10: System Delivery Practices  
      • Vendor Management  
      • Construction Quality  
      • Commissioning  
      • Turnover  
    • Module11: Operational Support Practices  
      • Asset Management  
      • Calibration  
      • Maintenance  
      • Decommissioning  
    • Module12: Ancillary Support Practices  
      • Engineering Storage  
      • Waste Management  
      • Facility/Equipment Repurposing  
  • GEP Enablers  
    • Module 13: Engineering Quality Process  
      • Specific tie-ins to BG5 process  
    • Module 13 Workshop 04: Equipment Qualification Plan (EQP) Deliverables  
  • Facility Project Management
    • Guide Introduction
    • Human Resource Management
    • Risk Management
    • Project Initiation
    • Project Delivery Planning
    • Pharmaceutical Specific Design Planning and Delivery
    • Implementation: Procurement
    • Implementation: Construction
    • Implementation: Testing and Commissioning
    • Project Closeout 

Who Should Attend

  • Those new to the pharmaceutical industry or those in the industry, wanting to expand their knowledge
  • Engineering/Project Engineers
  • Commissioning/Validation roles
  • Development/Manufacturing Operations
  • Facilities support functions
  • Quality Assurance, Quality control, Compliance
  • Qualified Persons in Europe
  • Managers/Supervisors
  • Service Providers/Consulting/Contractors/Suppliers 

Community of Practice (COP)

This certificate is of particular interest to:  

  • Existing members of the various ISPE CoPs, with an interest in engineering requirements
  • Existing and future members of the ISPE ATMP CoP
  • Existing and future members of the ISPE Process/Product Development CoP
  • Members focused on manufacturing risk assessment/mitigation 

Pricing

Ala Carte PriceNon-Member Certificate PriceMember Certificate PriceEE/Gov/Academia
$4,520.00$2,950.00$2,450.00$720.00

Now Your Whole Team Can Participate in an ISPE Learning Experience

  • 3 - 5 participants - Save 10%
  • 6 - or more participants - Save 20%

Group discount applies to Member/Nonmember rate only. To qualify, all registrant information must be submitted at the same time. Registrations that arrive later will NOT be eligible for the group discount. Cannot be combined with other offers. To register as a group, please contact ISPE by telephone, +1-813-960-2105 or by email, ask@ispe.org.


Cancellations/Refunds

Cancellations must be made in writing. If cancellations are received by 60 days prior to event start date, a full refund, minus a $150 handling fee, will be issued. After that time, no refunds will be granted. Please be advised that if your payment or written cancellation notice is not received prior to the cancellation date, your credit card will be charged the prevailing rate. Refund requests must be in writing and emailed or faxed to +1 (813)-264-2816. (Telephone messages are not accepted). ISPE reserves the right to modify the material or presenters for this event without notice, or cancel an event. If an event must be canceled, registrants will be notified by ISPE. ISPE will not be responsible for airfare penalties or other costs incurred due to cancellation.

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For an enhanced learning experience, ISPE also offers these learning activities as live courses and gives you an opportunity to learn with a live instructor, ask questions, and participate in exercises. View Upcoming Courses