Biopharmaceutical Manufacturing Facilities: Applying the Biopharmacetucial Manufacturing Facilities Baseline® Guide
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ISPE CEUs*: 1.5 |
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Date |
Location |
Country |
Instructor(s) |
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17-18 Nov 2008 |
San Diego Classroom Training Series |
United States |
Description
This advanced course in facility design provides an overview of the concepts utilized in the development of sound designs for facilities that manufacture biopharmaceutical products in today’s regulatory environment. The course will include a review of facility design and regulatory issues important in the US and Europe that involve industry trends and changing regulatory policy, using the Biopharmaceutical Manufacturing Facilities Baseline® Guide as the primary reference tool. 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.
Experienced individuals who want to improve their working knowledge of biotechnology manufacturing facility design concepts will find this course beneficial. The course has been developed for 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 will also find value in this course.
Course participants will receive a complimentary copy of the Biopharmaceutical Manufacturing Facilities Baseline® Guide.
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
- Utilize terminology
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; and individuals who provide services and/or assistance to biotechnology manufacturing companies to design, construct, validate, and finance facilities
Communities of Practice (COPs)
Biotechnology
Related Technical Documents
Biopharmaceutical Manufacturing Facilities Baseline® Guide
Important Course Notes
- Includes Webinar, a pre-recorded, Web-based session providing a review of basics prior to the classroom course
- Course contains information related to the Certified Pharmaceutical Industry ProfessionalSM ( CPIPSM ) technical knowledge competency element of Facilities and Equipment - www.ISPE-PCC.org
This course includes a pre-recorded Webinar that provides a review of the basics prior to the classroom course. You will receive information via email on how to access the Webinar two weeks prior to the start of the training event.
ISPE will provide continuing education units (ISPE CEUs) for all North American seminars and courses, including educational programming at the ISPE Annual Meeting. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession.
Delegates attending European seminars and courses will receive a Certificate of Attendance, as ISPE CEUs are currently not offered at European events. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be mailed within four weeks of evaluation materials. One hour of education programming equals 0.1 ISPE CEU credits.