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I first joined ISPE when I was a 28-year-old manager of maintenance. I wanted to get active in an organization of professionals who had a passion for making a difference. ISPE is the only society that provides a global opportunity for members of the industry, regulators, and academics to come together to analyze current approaches and find more effective solutions to the challenges facing us today.
Timothy Tyson, President/CEO
Valeant Pharmaceuticals International, USA
Watch the Video:
True Stories: What it means to be an ISPE Member - (WMV, 16 MB)
(Click to begin, or right-click to download and view later)
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Training |
Drug Manufacturing Facility Design (Includes On-line Essential)
Upcoming Dates and Locations
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.
This course contains knowledge related to the CPIP™ technical knowledge competency element Facilities and Equipment. For complete information concerning the knowledge elements or the CPIP Credential, please visit www.ispe-pcc.org.
On-line Essentials Learning Objectives
- Understand introductory GMP design issues
- Utilize industry guidance references
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
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 mailed within four weeks of evaluation materials. One hour of education programming equals 0.1 ISPE CEU credits.
About On-line Essentials
This course includes On-line Essentials, a pre-recorded, Web-based session that provides a review of the basics prior to the classroom course. You will receive information via email on how to access the On-line Essential two weeks prior to the start of the training event.
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