ISPE CEUs: 1.5
PMI® PDUs: 2.0
Type: Classroom Training Course
ISPE has been reviewed and approved as a provider of project management training by the Project Management Institute (PMI®).
This course has been updated to include content from the Project Management Institute, A Guide to the Project Management Body of Knowledge (PMBOK Guide®, Fifth Edition, Copyright 2013).
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 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.
- Introduction: Biomanufacturing design considerations
- The role of Quality by Design (ICH Q8) in facility design
- Regulatory expectations - Designing for Compliance
- QbD in Facility Design
- Defining the process - CQAs, CPPs, Design Space
- Equipment considerations
- Facility considerations
- Utility and Support systems
- Facility Qualification, Verification, and Process Validation
- Risk Assessment (ICH Q9)
- Reference materials: ICH Q8, ICH Q9, ASTM E2500, 2011 FDA Guidance for Process Validation
This course includes a pre-recorded Webinar that provides a review of the basics prior to the classroom course. Access information will be provided via email one week prior to the start of the training event.
Webinar Learning Objectives:
- Define controlled processing, primary and secondary segregation, personnel flow, open versus closed systems, and single-product versus multi-product manufacture.
- Discuss regulatory philosophy, manufacturing operations, process and equipment considerations, process support, facility integration, process controls, automation, and commissioning and qualification of biopharmaceutical manufacturing facilities.
- Describe additional references available in the Biopharmaceutical Manufacturing Facilities Baseline® Guide.
Take Back to Your Job
- Discuss facility design concepts related to current Good Manufacturing Practices (cGMPs)
- Describe the regulatory review process
- Apply engineering design principles related to biotechnology product manufacturing
- Understand biotechnology process attributes that impact equipment and facility design
- Utilize current industry guidance documents that impact facility design
- Describe impact of critical utilities on facility design
- Understand project economics and their impact on facility design
- Discuss current industry trends impacting facility design and construction
Attendance Suggested For
- Individuals who want to improve their working knowledge of biotechnology manufacturing facility design concepts
- Professionals who need a focused understanding of the issues a biotechnology manufacturing company must address in order to develop a facility design that meets current regulatory requirements and corporate economic goals
- Individuals who provide services and/or assistance to biotechnology manufacturing companies to design, construct, validate, and finance facilities
Community of Practice (COP)
This training course is of particular interest to existing and future members of the ISPE Biotechnology Community of Practice (COP).
Continuing Education Units
ISPE will provide continuing education units (ISPE CEUs) for all North American and European courses. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be available for download in your ISPE account within four weeks of the completion of training. Instruction for download will be sent when the CEUs are available. One hour of education programming equals 0.1 ISPE CEU credits.