Applying the Biopharmaceutical Manufacturing Facilities Baseline® Guide Principles
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.
What You Will Learn
- 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
Resources and Activities
- Pre-Course Work Materials
- Interactive Exercises
- Learning Assessments
- ISPE Baseline Guide Vol 6: Biopharmaceutical Manufacturing Facilities 2nd Edition
- 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
- Reference materials: ICH Q8, ICH Q9, ASTM E2500, 2011 FDA Guidance for Process Validation
Who Should Attend
- 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
Additional Course Details
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.
- 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.
Communities of Practice
This training course is of particular interest to existing and future members of the ISPE Biotechnology Community of Practice (COP).