Drug Manufacturing Facility Design and Development (T09)

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

Description

This course provides an overview of the concepts utilized in the development of sound designs for facilities that manufacture pharmaceutical products in today's regulatory environment. The course will include a review of facility design and regulatory issues in the U.S. and Europe that involve industry trends and changing regulatory policy.

The course will include current case studies on a wide array of facility topics as well as a class exercise in developing a facility scope of work and deliverables.

Course Modules

• GMPs
• Regulatory Review
• Guidance
• Facility Issues
• Process Basics
• Architecture Design
• Process Equipment Design
• Mechanical/HVAC Design
• Pharmaceutical Water Design
• Utilities Design
• Project Management
• Cost Impacts & Metrics
• Qualification & Commissioning
• Validation
• Change Control
• Facility Licensing
• Industry Trends
• Appendix

Take Back to Your Job

• Discuss facility design concepts related to current Good Manufacturing Practices (cGMPs)
• Explain the roles and responsibilities of project team members in defining facility needs and scope
• Cite engineering design principles related to sterile product manufacturing
• Identify pharmaceutical and biotechnology process attributes that impact facility design
• Locate current industry guidance documents that impact facility design
• Define the facility licensing process and project life cycle definitions
• Discuss project economics and its impact on facility design
• Describe current industry trends impacting facility design and construction

Attendance Suggested For

• Individuals who want to improve their working knowledge of pharmaceutical manufacturing facility design concepts.
• Professionals who need a focused understanding of the issues a pharmaceutical manufacturing company must address when designing a facility that meets current regulatory requirements and corporate economic goals.
• Individuals who provide services and/or assistance to pharmaceutical manufacturing companies to design, construct, validate, and finance facilities.

Includes Webinar 

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 one week prior to the start of the training event.

Webinar Learning Objectives

• Understand introductory GMP design issues
• Utilize industry guidance references

CPIP™ Technical Knowledge 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.