Applying the Biopharmaceutical Manufacturing Facilities Baseline® Guide Principles (T31)

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Training

Level: Advanced
ISPE CEUs: 1.5
Type: Classroom Training Course
Includes Webinar

Date	Location	Country	Instructor(s)
This course is not currently scheduled, but may be conducted at your company. Please contact ISPE for more information.

Description

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.

Baseline Guide Cover Image

Immediately apply the course objectives using the complimentary copy of the Biopharmaceutical Manufacturing Facilities Baseline^® Guide.

Course Modules

Day 1

Introduction: Biomanufacturing design considerations
The role of Quality by Design (ICH Q8) in facility design
Regulatory expectations - Designing for Compliance
Defining the process - CQAs, CPPs, Design Space
Equipment considerations

Day 2

Facility considerations
Utility and Support systems
Facility Qualification, Verification, and Process Validation
Risk Assessment (ICH Q9)
Project Delivery platform impact
Reference materials: ICH Q8, ICH Q9, ASTM E2500, 2011 FDA Guidance for Process Validation

Includes Webinar

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).

CPIP™ Technical Knowledge and Competency Elements

This course contains knowledge related to the CPIP™ technical knowledge competency element Facilities and Equipment: Design and Construction / Installation. For complete information concerning the knowledge elements or the CPIP Credential, please visit www.ISPE-PCC.org.

Continuing Education Units

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 sent via email within four weeks of evaluation materials. One hour of education programming equals 0.1 ISPE CEU credits.

Last Update: 19 June 2013